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Study Objectives The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/CT. Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days. Conditions: Head and Neck Cancer Intervention / Treatment:
Inclusion Criteria: * A signed informed consent.* Known or suspected primary cancer of the upper aerodigestive tract, which may be determined by biopsy, physical examination- including upper endoscopy or noninvasive imaging studies including CT, MR, ultrasound, or prior PET.* Known or suspected metastatic disease to cervical lymph nodes based on physical examination, imaging studies or biopsy.* Scheduled for routine clinical imaging at the ACB PET/CT facility.* Participant must be at least 18 years of age. Exclusion Criteria: * Prior treatment (chemotherapy, radiotherapy) for cancer of the upper aerodigestive tract.* Prior biopsy procedures, including resection of the primary cancer, will not exclude the patient from participation.* Uncontrolled blood glucose levels (>200 mg/dl).* Patient is unable to comprehend the requirements of the study.* Patient is unable to undergo scanning of the neck with the PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).
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Study Objectives The aim of the study is to evaluate the efficacy and safety of the various types of stents available for biliary drainage in patients with neoplastic stenosis of the common bile duct and to evaluate the adherence to the current guidelines available. Conditions: Common Bile Duct Stricture, Jaundice; Malignant Intervention / Treatment:
Inclusion Criteria: * Common bile duct stricture (i.e. jaundice and/or cholangitis) of malignant origin * Patients > 18 years old * Obtaining informed consent Exclusion Criteria: * Lack of sufficient clinical and laboratory data to define clinical efficacy and/or follow-up available <1 month
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Study Objectives The presence of portal vein tumor thrombosis (PVTT)in patients with HCC is one of the most significant prognostic factors for poor prognosis, without treatment, their survival is less than 3 months. In the HCC patients who combined with PVTT, RT showed 50% of local control and about 10 months survival duration. Despite the standard treatment of the HCC combined with PVTT is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an option in those patients. Investigators previously reported the retrospective study that the scheduled interval TACE followed by RT for HCC combined with PVTT and 60% of the patients showed objective response without significant elevation of complication. It is reported that hyperthermia considered as the most valuable radiosensitizer in cancer treatment, theoretically. Based on those studies, we start this prospective study to evaluate the objective response and adverse event in the combination treatment of RT and hyperthermia after Transarterial chemoembolization (TACE) in the unresectable HCC patients who combined with PVTT. Conditions: Carcinoma. Hepatocellular Intervention / Treatment: RADIATION: RT and hyperthermia after TACE
Inclusion Criteria: * Patients must have a diagnosis of HCC by at least one criterion listed below (korean liver cancer study group (KLCSG) guideline 2009) 1.1 Pathologically (histologically or cytologically) proven diagnosis of HCC 1.2 Liver nodule in high risk group 1.2.1 If alpha fetoprotein (AFP) ≥200 ng/mL , ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI 1.2.2 If AFP<200 ng/mL, ≥2 typical HCC enhancing pattern on dynamic contrast enhanced CT, MRI, and angiography 1.3 ≥ 2 cm nodule in liver cirrhosis (LC), ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI* Patients must have a diagnosis of PVTT 2.1 Early arterial enhancement and delayed washout on multiphasic CT or MRI* Eastern cooperative oncology group performance status 0 1 2* Age ≥ 20* Unsuitable for resection or transplant or RFA* Unsuitable for or refractory to TACE or drug eluting beads (DEB)* Agreement of study-specific informed consent* Assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry?* Child-Pugh score A-B within 7 days prior to study entry* Normal liver (Liver minus gross tumor volume) ≥ 700 cc* Blood work requirements * Absolute neutrophil count (ANC) ≥ 1,500 /mm3, Platelet ≥ 70,000/mm3, Hgb ≥ 8 g/dl * Liver function test (LFT): Total bilirubin<3.0 mg/dL, International normalized ratio(INR) < 1.7, Albumin ≥ 2.8g/dL, Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT)< 6 X normal * Serum creatinine < 1.5 X normal, or creatinine clearance ≥ 60 mL/min* Male, consent contraception at least 6 months* Childbearing potential woman, consent contraception at least 6 months* Life expectancy more than 12 weeks* Stable breathing more than 5 minutes Exclusion Criteria: * Complete obstruction of main portal vein* Pregnant and/or breastfeeding woman* Previous upper abdominal RT history* Uncontrolled active co-morbidity* Another primary cancer history within 2 years* Uncontrolled ascites or hepatic encephalopathy* Connective tissue disease which known as radiation hypersensitivity* Uncontrolled moderate to severe gastroduodenal ulcer or esophagogastric varices
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Study Objectives RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: A phase I trial to study the side effects of vaccine therapy in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer. Conditions: Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer Intervention / Treatment: BIOLOGICAL: NY-ESO-1 peptide vaccine
Inclusion Criteria * Histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, from Stage II-IV at diagnosis, receiving initial cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen.* High risk feature defined as suboptimal primary debulking (remaining tumor masses with diameter ≥ 1.0 cm) or failure to normalize CA125 during primary therapy by the end of the third cycle or positive second-look surgery.* Patients must be in complete clinical remission defined as CA125 < 35 units, negative physical examination and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm that are often present in the pelvis may not be considered definite evidence of disease.* Expected survival of at least 6 months.* Karnofsky performance scale ≥60%.* Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified: * Absolute neutrophil count (ANC) ≥1000/mm\^3 * Platelets ≥ 80,000/mm\^3 * Creatinine ≤ 1.5mg/dL * Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and total bilirubin all < 2.5 x upper limit of normal (ULN) 7 Age ≥ 18 years. * Able and willing to give valid written informed consent. 9. HLA A02 positive. Exclusion Criteria Patients were excluded from the study for any of the following reasons: * Clinically significant heart disease (NYHA Class III or IV).* Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders.* Patients with serious intercurrent illness, requiring hospitalization.* Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.* Patients taking immunosuppressive drugs such as systemic corticosteroids or non-steroidal anti-inflammatory drugs.* Known HIV positivity.* Other malignancy within 3 years prior to entry into the study, except for treated nonmelanoma skin cancer and cervical carcinoma in situ.* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.* Lack of availability for immunological and clinical follow-up assessments.* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.* Pregnancy or breastfeeding.* Women of childbearing potential: Refusal or inability to use effective means of contraception.
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Study Objectives The home confinement caused by the COVID-19 pandemic has aroused the need to use telematic communication systems to provide remote treatments. More and more research is being done on preoperative respiratory physiotherapy in patients undergoing thoracic surgery with lung cancer. It is a treatment that has great relevance in the prevention of postoperative complications and in the quality of life of the patient. Therefore, this study is proposed to highlight the applicability of a telematic system of preoperative physiotherapy treatment with the FISSIOS application at the Hospital de la Santa Creu i Sant Pau (HSCSP). Conditions: Lung Cancer, Physical Therapy, Thoracic Surgery, Preoperative Intervention / Treatment: DEVICE: mobile app
Inclusion Criteria: * Patients aged 18-> 80 years. Candidates for CP resection with curative intent, either for VATS or thoracotomy, which meet the ppo-DLCO> 35% and ppo-FEV1> 35% surgical criteria, who agree to participate and sign the informed consent Exclusion Criteria: * Patients undergoing tumor resection for cancer requiring pneumonectomy, with cognitive impairment, which are outside the area of influence of the HSCSP or which do not have from an Android / iPhone Operating System (iOS) device. It is also considered an exclusion criterion not fulfilling 50% of the predefined time of the program (a week and a half) and surgical.
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Study Objectives Data on disease recurrence was collected for all primary colon cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locoregionally recurrent colon cancer were determined. Conditions: Colonic Neoplasms, Neoplasm Recurrence, Local Intervention / Treatment:
Inclusion Criteria: * Histologically confirmed stage I-III primary colon carcinoma; * Diagnosed between January 1st and June 30th of 2015; * Surgical resection of primary colon carcinoma. Exclusion Criteria: * Appendiceal localization; * Neuroendocrine tumor morphology;
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Study Objectives This is a Phase II, single-arm study of ofatumumab investigating the safety of an accelerated infusion schedule of ofatumumab in patients who have received at least one prior therapy for CLL. The primary endpoint is to evaluate the number of subjects able to complete infusion number 3 (2000 mg) within 15 minutes of the planned time. Conditions: Chronic Lymphocytic Leukemia Intervention / Treatment: DRUG: Ofatumumab
Inclusion Criteria: * CD20+ B-cell chronic lymphocytic leukemia (B-CLL) according to International Workshop on CLL Working Group (IWCLL WG) Diagnostic Criteria.* Have received at least one prior therapy for CLL. *If previously treated with ofatumumab must have achieved at least a partial response (PR) and maintained PR for >= 6 months.* Requires treatment according to IWCLL-Working Group guidelines.* Eastern Cooperative Oncology Group Performance Status (ECOG PS) <=1.* Laboratory parameters <=7 days prior to treatment initiation: 1. Creatinine <= 1.5 mg/dL upper limit normal (ULN) 2. Aspartate amino transferase (AST) or alanine amino transferase (ALT) <= 3.0 x ULN 3. Alkaline phosphatase (ALP) <= 3.0 x ULN 4. Total Bilirubin level of < 1.5 mg/dL x the institutional ULN unless secondary to Gilbert's disease (or pattern consistent with Gilbert's)* Hepatitis B sAg negative and HepB cAb negative. Note: Patients who are HepB sAg negative but are HepB cAb positive (regardless of HepB sAb status) will NOT be allowed.* Women of childbearing potential must have a negative serum pregnancy test performed <=72 hours prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.* Accessible for treatment and follow-up.* Able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.* No prior antibody therapy for CLL within the previous 3 months. Exclusion Criteria: * Previous treatment with ofatumumab that resulted in a Grade 3 or 4 infusion reaction.* Treatment for CLL within last 4 weeks. (Patients who have received steroids or IVIG for autoimmune complications of CLL are eligible).* Current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease, per assessment by the treating physician).* Active bacterial or viral infection or infection requiring intravenous antibiotic treatment at the time of accrual.* Central nervous system lymphoma/CLL.* Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (i.e., Richter's transformation).* History of other malignancy <= 2 years of study entry which could affect compliance with the protocol or interpretation of results. History of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, low grade, early-stage, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ (DCIS) of the breast treated with curative intent, are generally eligible.* Active hepatitis B or C or known HIV positive.* Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to visit 1, whichever is longer.* History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae.* Clinically significant cardiac disease including unstable angina, acute myocardial infarction (within 6 months of enrollment), congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.* Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.
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Study Objectives The primary objective is to estimate the proportions of vestibular schwannomas (VS) and meningiomas after 10 days of exposure to the study drug RAD001 at a dose of 10 mg daily, as determined by immunohistochemistry. This is a "phase 0" PK (pharmacokinetic) and PD (pharmacodynamic) study of RAD001 in patients with Neurofibromatosis Type 2-related and sporadic VS and meningiomas. Enrolled patients will take RAD001 prior to a scheduled VS or meningioma surgery, and blood and tissue samples will be obtained for further analysis. Conditions: Neurofibromatosis Type 2, Vestibular Schwannomas, Meningiomas Intervention / Treatment: DRUG: RAD001
Inclusion Criteria: * Patients must satisfy all of the following eligibility criteria: * Karnofsky performance status (KPS) ≥ 60% * Absolute neutrophil count ≥ 1,000/mm³ (unsupported) * Platelet count ≥ 100,000/mm³ (unsupported) * Hemoglobin ≥ 8 g/dl (transfusion support allowed) * Creatinine ≤ 1.5 times upper limit of normal (ULN\*) OR corrected glomerular filtration rate ≥ 70 ml/min * Total bilirubin ≤ 1.5 times ULN\* * ALT ≤ 2.5 times ULN\* * Serum albumin ≥ 2 g/dl * INR < 1.3 (or < 3 on anticoagulants) * Patients taking a cholesterol-lowering agent must be on a single medication and on a stable dose for at least 4 weeks * Fasting serum cholesterol ≤ 300 mg/dl OR ≤ 7.75 mmol/l AND fasting triglycerides ≤ 2.5 times ULN\*. * Fully recovered from acute toxic effects of any prior chemotherapy, biological modifiers or radiotherapy * Any neurologic deficits must be stable for ≥ 1 week * Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. The anti-proliferative activity of this experimental drug may be harmful to the developing fetus. * Able to provide written informed consent Exclusion Criteria: * Patients with any of the following are ineligible for this research study: * Patients with VS or meningiomas deemed very high surgical risk for stroke and/or other complications by the attending surgeon, such as meningiomas with major vascular or dural sinus infiltration. * Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety. * Symptomatic congestive heart failure or unstable angina pectoris. * Uncontrolled diabetes, as defined by fasting serum glucose >1.5 times ULN\*. * Current active hepatic or biliary disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis (with exception of patients with Gilbert's syndrome and asymptomatic gallstones). * History of hepatitis B or C. Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV serology, DNA and/or HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection. If no positive medical history for risk factors, serology is not required. * Seropositivity or DNA/RNA positivity for hepatitis B or C, with the exception of patients who have received prior Hepatitis B vaccination and are Anti-HBs positive only. * Known HIV seropositivity * Neurologic deficits that are rapidly progressing: all neurologic signs and symptoms must have been stable for a week prior to first dose * Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant. * Anti-tumor therapy (i.e. chemotherapeutics or investigational agents or immunotherapy) within 4 weeks prior to enrollment * Radiation therapy to a study target lesion within 6 months * Prior therapy with mTOR inhibitors, including sirolimus, temsirolimus, deforolimus within 6 months prior to enrollment * Known hypersensitivity to RAD001 or other rapamycins (sirolimus, temsirolimus, deforolimus) * Patients with a concurrent malignancy * Patients treatment with systemic steroids or another immunosuppressive agent. Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. * Patients cannot receive CYP3A4 inhibiting drugs including antibiotics (clarithromycin, erythromycin, troleandomycin), anti-HIV agents (delaviridine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, lopinavir), antifungals (itraconazole, ketoconazole, fluconazole at doses > 200 mg/day, voriconazole), antidepressants (nefazodone, fluovoxamine), calcium channel blockers (verapamil, diltiazem) oramiodarone * Patients should avoid CYP3A4 inhibiting foods including grapefruit and Seville orange juice. * Patients cannot receive CYP3A4 inducing anticonvulsants including carbamazepine, felbamate, phenobarbital, phenytoin, primidone and oxcarbazepine, or other CYP3A4 inducers such as St. John's Wort * Patients who previously received CYP3A4 inducers or inhibitors must have discontinued these medications within at least 1 week prior to study entry and can re-start them 1 week post-operatively (or earlier if determined to be of clinical benefit, as determined by the treating physician). * of institutional norms
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Study Objectives The study aims to assess the existence of intraluminal malignant cells and the appropriate fluid volume needed to perform rectal washout during transanal total mesorectal excision (taTME) for rectal cancer. Conditions: Rectal Cancer Intervention / Treatment: PROCEDURE: Rectal washout
Inclusion Criteria: * Surgery at Slagelse Hospital for rectal cancer with transanal mesorectal excision * Consent to participate in the study Exclusion Criteria: * No consent to participate * No surgery
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Study Objectives Use of oral contraceptives (OCs) reduces a woman's risk of ovarian cancer very significantly and the protective effect continues for at least 25 years after use of OCs is stopped; the mechanisms of how this occurs are not understood. We are proposing here to directly study the effect of OCs on the fallopian tube and inclusion cysts within the ovary - sites from which most ovarian cancers are thought to arise - in order to better understand the mechanistic basis for OC protection against ovarian cancer. We think the protection results from reduced cell proliferation. It will lay the foundation for further studies to ensure that the protection against ovarian cancer afforded by 'traditional' OCs is not lost with alterations in OC formulation, and, if possible, to guide development of OC formations to improve further on the protection afforded by OCs. Conditions: Ovarian Cancer Risk, Risk-reducing Surgery, Fallopian Tube Fimbriae, Ovarian Cortical Inclusion Cysts Intervention / Treatment: DRUG: OrthoNovum 1/35
Inclusion Criteria: * Premenopausal * 30 and 45 years of age * Scheduled to undergo a laproscopically conducted RR-BSO, risk reducing salpingectomy, salpingectomy for sterilization, or salpingectomy with hysterectomy for non-cancer related conditions * Have at least one ovary Exclusion Criteria: * Past hysterectomy * Past diagnosis of ovarian cancer * Use of Tamoxifen, Raloxifene or hormone replacement therapy in the past 3 months * Use of Chemotherapy in the last 6 months
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Study Objectives Radiotherapy (RT), at a total dose of 60-66 Gy over 6 weeks, combined with platinum-based chemotherapy, is the standard of care for stage III Non-Small Cell Lung Cancers (NSCLC) patients with unresectable or inoperable disease. However, the long-term outcomes are poor, with a 5-year overall survival (OS) rate of 15-35% for stage IIIA, and 5-10% for stage IIIB patients. The recent association of immunotherapy has been proven to improve Progression Free Survival (PFS) and OS for these patients and durvalumab consolidation following chemoradiotherapy (CT-RT) is now the new standard of care. Compared to older technics (2Dimensions(D) and 3D-RT), intensity-modulated radiotherapy (IMRT) allows for improved organs-at-risk sparing, owing to the high dose conformation to the target volume, thus reducing toxicity rates. In regard to the recent results of adjuvant immunotherapy, the benefits of concomitant chemotherapy with radiotherapy could be re-evaluated. With the changing landscape in the standard treatment of Local Advanced NSCLC (LA-NSCLC), the reduction in treatment-induced toxicity, while maintaining optimal tumor control, has become a priority, thereby warranting access to adjuvant immunotherapy for these patients. Due to the toxicity of the chemoradiotherapy, a large subset of patients may be unfit for the adjuvant immunotherapy. The use of immunotherapy concomitant to radiotherapy without chemotherapy may be the next step. Nevertheless, as immune cells are highly sensitive to conventional RT doses, the paradigm of the standard irradiation volumes should be reconsidered. In this context, the introduction of IMRT to spare lymphatic tissues and bone marrow deserves evaluation in prospective trials. A strong body of evidence supports the combination of RT with immunotherapy such as a Programmed cells Death-1 (PD1) inhibitor. Radiation alone can modify the immune response in several ways to allow for synergistic effects when combined with immunotherapy. The reduction in treatment-induced toxicity while maintaining optimal tumor control has become a priority, thereby warranting access to adjuvant immunotherapy for these patients. In this context, the introduction of IMRT to spare lymphatic tissues and bone marrow deserves evaluation in prospective trials. The timing of administration of immunotherapy seems to be a major point. Previous data in mice showed that an improved survival benefit with concurrent anti-PD-Ligand1 (PD-L1) and RT versus sequential administration. Moreover, for sequential schedule, an improved survival outcome was found for patients receiving first dose of durvalumab within 14 days of last radiotherapy fraction compared to 14 days or greater. Furthermore, immunotherapy combined with radiotherapy appears to be safe, without increase of the toxicity. In summary, there is a strong rationale for testing this new paradigm of accelerated IMRT combined with concurrent and maintenance nivolumab for locally advanced non-small lung cancer, due to: * The unmet medical need for new Standard Of Care (SOC) better tolerated and " as " or " more " effective treatment than CT-RT * The need to decrease radiation-induced toxicity * The limit of CT-RT followed by durvalumab consolidation, leading to a high rate of recurrence within the 18 months (18-month PFS rate of 44.2%) * The strong rationale to combine RT and PD-1 inhibition It is hypothesized this innovative concept to be safe in the context of this study for the following reasons: * The use of moderate accelerated intensity-modulated radiotherapy (H-IMRT) allows decreasing both the Overall Treatment Time (OTT) and the dose to the organs at risk * The decrease of the OTT (24 fractions instead of 33 fractions) combined with a decrease of the toxicity should represent a potential clinical benefit. Conditions: Non Small Cell Lung Cancer Stage III Intervention / Treatment: COMBINATION_PRODUCT: Nivolumab and Intensity Modulated Radiotherapy (IMRT)
Inclusion Criteria: * Stage III non-small lung cancer; * Patient with at least one of these fragility criteria: * Status ECOG 1 with multiple comorbidities, at least 2 pathologies with grade ≥ 2 (renal and/or cardiac and/or vascular and/or hepatic, and/or neurologic, and/or pulmonary) * Status ECOG = 2 * Age > 74 years * Age ≥ 70, unfit to receive chemotherapy * Eligible to radiotherapy, defined by multidisciplinary tumor board; * Performance Status Eastern Cooperative Oncology Group (ECOG) 0-2; * Age ≥ 18 years; * Metastasis (M)0 based on clinical, Magnetic Resonance Imaging (MRI) of brain and FluoroDeoxyGlucose (FDG)/ Positron Emission Tomography (PET)- computerized tomography (CT) examinations; * Written informed consent Exclusion Criteria: * Patients eligible to surgery * Any prior or current treatment for invasive lung cancer * History of other malignancy within the last 3 years (exception of in situ carcinoma, skin carcinomas, localized prostate carcinoma Gleason 6 and in situ breast carcinoma) * Significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial * Known hypersensitivity reaction to nivolumab * Prior organ transplantation including allogenic stem-cell transplantation * Any social, personal, medical and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent
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Study Objectives This study describes the survival outcomes of advanced stage breast, colorectal, ovarian and pancreatic cancer patients receiving advanced integrative oncology (AIO) treatment at participating North American integrative oncology clinics. This study also aims to describe the integrative treatments recommended by naturopathic doctors (NDs) for these participants alongside their conventional care treatments. Sub-studies will evaluate health-related quality of life, cost of cancer care, and qualitative experience of care in a subset of Canadian participants. Conditions: Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms Intervention / Treatment:
Inclusion Criteria: * A new patient coming in for a first office call (FOC) with a participating site investigator for their cancer or a current patient whose FOC with a participating investigator for their cancer was after study start date of January 1, 2015 * ≥18 years of age * Able to understand study design and provide signed informed consent to enrollment * Confirmed diagnosis of one of the following cancers: stage 4/metastatic breast, stage 4/metastatic colorectal, stage 3 or 4/metasatic ovarian, or stage 3 or 4/metastatic pancreatic * Canadian participants with a visit <3 months post-FOC are eligible for the HRQOL sub-study * Participants must be governed by the laws of the country within which they are receiving AIO care Exclusion Criteria: * None
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Study Objectives This is an observational, retrospective and monocentric study, conducted at the university Hospital of Brest The primary objective is to assess the association between the occurrence of thyroid dysfunction in patients treated with Nivolumab® for a non-small cell lung cancer and prognosis and therapeutic response The second objective is to assess prognosis and therapeutic response according to severity and subtype of thyroid dysfunction Conditions: Non Small Cell Lung Cancer Metastatic, Treatment Adverse Effect, Thyroid Dysfunction, Immune Checkpoint Inhibitor, Prognosis Intervention / Treatment:
Inclusion Criteria: * patients at least 18 years old and had histologically confirmed locally advanced stage (IIIB) or metastatic (IV) non-small cell lung cancer with disease progression; * treated with Nivolumab® as second or more therapeutic line * in the oncologic department university hospital of Brest * during the inclusion period between July 20, 2015 to June 30, 2018. Exclusion Criteria: * patients whose primary tumor was not from bronchopulmonary origin * patients with a history of total thyroidectomy and/or having previously treated with levothyroxine and/or having a thyroid dysfunction previously to the introduction of Nivolumab® * patients not having any thyroid monitoring during Nivolumab® treatment, and those for which data were missing * patients who expressed their opposition to participate in the study
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Study Objectives The purpose of this study is to see if the cells in rectal cancer are oxygen-starved, or hypoxic. We know that as cancers grow bigger, parts of them are cut off from the oxygen supply and they become hypoxic, basically, lacking oxygen. Research has shown that cells that are oxygen-starved respond differently to treatment such as chemotherapy and radiation when compared to cells that are oxygen rich. Conditions: Rectal Cancer Intervention / Treatment: PROCEDURE: Eppendorf hypoximeter
Inclusion Criteria: * Biopsy proven adenocarcinoma of the rectum. If a biopsy was taken at an outside hospital, the slides and diagnosis will be reviewed and confirmed by a pathologist at MSKCC. * Mid to distal rectal tumors not requiring pre-op radiation or chemotherapy * Age ≥ 18 * Age < 90 * Karnofsky performance status ≥ 60 * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Current pregnancy * Uncontrolled intercurrent illness that would limit compliance with study requirements.
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Study Objectives The pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response rate and increasing the resectability of initially inoperable rectal cancer. Conditions: Inoperable or Recurrent Rectal Cancer Intervention / Treatment: DRUG: Tomudex, PROCEDURE: Radiotherapy, PROCEDURE: Haematology, PROCEDURE: Biochemistry
Inclusion Criteria: * Confirmed diagnosis of inoperable/recurrent rectal cancer * Age > 18 years * At least 1 measurable lesion should be present * WHO performance score < 2 * Life expentancy of at least 12 weeks * Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy * Documented informed consent to participate in the trial Exclusion Criteria: * Previous systemic chemotherapy * Previous radiotherapy to the planned exposure area * Subjects with distant metastases * (a)white blood cell < 4.0x109/L (unless absolute neutrophil count is >2.0x109/L or (b) Platelet count < 100x109/L * Serum creatinine above the upper limit of the normal range * (a) Serum bilirubin > 1.25 times the upper limit of the normal range or (b) Asparate aminotransferase(AST) or Alanine amiontransferase (ALT) >2.5 times the upper limit of the normal range * Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial period * Pregnancy or breast feeding. Women of childbearing age must use effective contraception * Previous or current malignancies at other sites, with the exception of adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin * Patient participation in other studies
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Study Objectives The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in Adult Participants with Select Advanced Solid Tumors Conditions: Solid Tumors Intervention / Treatment: DRUG: Oleclumab, DRUG: Durvalumab
Inclusion Criteria: * Adult participants; age ≥ 18 * Written and signed informed consent must be obtained * Have histologic or cytologic documentation of solid tumor including EGFRm NSCLC * Participants must have at least 1 lesion that is measurable using RECIST guidelines * Participants must consent to provide archived tumor specimens or tumor biopsies for correlative biomarker studies. * Eastern Cooperative Oncology Group performance score of 0 or 1 * Adequate organ function Exclusion Criteria: * Prior treatment with tumor necrosis factor receptor superfamily agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR). One cohort also excludes anti CTLA-4, PD-L1, and anti PD-L1. * Participants who have received prior therapy with regimens containing CTLA-4, PD-L1, or PD-1 antagonists may be permitted to enroll under certain conditions * Cardiac or peripheral vascular disease meeting any of the following criteria: * Past history of myocardial infarction in the prior 12 months * Past history of stroke or transient ischemic attack requiring medical therapy * Congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification * Grade 3 or greater edema (eg, peripheral, pulmonary) * History of Grade 3 or greater thromboembolic events in the prior 12 months * Participants with active tuberculosis are ineligible. In settings where there is clinical or radiographic evidence of tuberculosis, active disease must be ruled out * Active or prior documented autoimmune or inflammatory disorders * Untreated central nervous system (CNS) metastatic disease * Known positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C * Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, uncontrolled hypertension, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirement
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Study Objectives The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Glufosfamide
Inclusion Criteria: * At least 18 years of age * Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided) * Metastatic pancreatic cancer * Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) for advanced/metastatic pancreatic cancer * Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion) * Recovered from reversible toxicities of prior therapy * Karnofsky performance status ≥70 * All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose * Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee Exclusion Criteria: * More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen) * Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to study start * Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects) * Active clinically significant infection requiring antibiotics * Known HIV positive or active hepatitis B or C * Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure * No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year * Major surgery within 3 weeks of the start of study treatment, without complete recovery * Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis) (Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain))
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Study Objectives This study will assess the safety, tolerability, and efficacy of every-3-week dosing (Q3W) of pembrolizumab (MK-3475) in participants with advanced melanoma; participants may receive pembrolizumab for up to 2 years if deriving clinical benefit. The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate. Conditions: Melanoma Intervention / Treatment: BIOLOGICAL: Pembrolizumab
Inclusion criteria: * Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * At least one measurable lesion * Adequate organ function Exclusion criteria: * Prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD ligand-1 (PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) agent * Is currently participating or has participated in a study with an investigational compound or device within 30 days, or 5X half-life of the investigational compound, whichever is longer, of initial dosing on this study * Chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (including monoclonal antibodies) within 4 weeks prior to the first dose of trial treatment, or not recovered (<= Grade 1 or baseline) from adverse events due to a previously administered agent * Expected to require any other form of systemic or localized antineoplastic therapy while in study * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents * Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study treatment * Received a live vaccine within 4 weeks prior to the first dose of trial treatment * Has a known hypersensitivity to the components of the study drug or another monoclonal antibody * History or evidence of active pneumonitis * Human immunodeficiency virus (HIV)-positive * Has known history of active Hepatitis B or C * Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial treatment through 120 days after the last dose of study medication
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Study Objectives The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve \[AUC1-85day\] for serum testosterone in patients with advanced prostate cancer. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
Inclusion Criteria: * Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy * Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start * Karnofsky performance index > 70 * Expected survival ≥ 9 months Exclusion Criteria: * Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (GnRH) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s) * Any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone * Patient at risk of spinal cord compression or ureter obstruction * Prior hypophysectomy or adrenalectomy
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Study Objectives This trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA) positron emission tomography (PET) works in patients with ovarian cancer to detect whether the tumor has spread to other places in the body. 68Ga-PSMA is a radioactive substance that binds to blood vessels around the ovarian cancer and can be imaged using PET. Diagnostic procedures, such as PET, may help find and diagnose find out how far the disease has spread. Conditions: Ovarian Carcinoma Intervention / Treatment: DRUG: Gallium Ga 68-labeled PSMA-11, PROCEDURE: Magnetic Resonance Imaging (MRI), PROCEDURE: Positron Emission Tomography (PET)
Inclusion Criteria: * Patients with one of the following, identified on prior imaging (CT, MRI or Ultrasound): 1. adnexal mass 2. abdominal or pelvic tumor suspicious for ovarian cancer metastases (either suspected on clinical grounds, or known from prior tissue sampling)* Female,* Age >= 18 years* Creatinine <= 1.5 mg/dL* Ability to understand a written informed consent document, and the willingness to sign it Exclusion Criteria: * Pregnant or breastfeeding women* Patient unlikely to comply with study procedure, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
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Study Objectives The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: 1. unknown adverse drug reactions (ADRs); 2. occurrence of ADRs; 3. factors that are likely to affect safety and efficacy; 4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; 5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression). Conditions: Partial Seizures (With or Without Secondary Generalized Seizures), Primary Generalized Tonic-clonic Seizures Intervention / Treatment: DRUG: Fycompa
Inclusion Criteria: * Epilepsy participants at least 18 years of age with: * Partial seizures (with or without secondary generalized seizures) * Primary generalized Tonic-clonic seizures Exclusion Criteria: * Participants previously treated with Fycompa
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Study Objectives Heparinized solution has been used for maintenance of arterial catheter during perioperative period. Although the infused dose of heparin is very low, the investigators examine whether the heparin effect is remained or not in blood using rotational thromboelastometry (ROTEM) analysis. Conditions: Brain Tumor, Spinal Stenosis, Cerebral Artery Anuerysm Intervention / Treatment: DRUG: Heparin
Inclusion Criteria: * Patients requiring continuous invasive arterial pressure monitoring during operation for anesthetic management. Exclusion Criteria: * heparin hypersensitivity * hematologic disease * anticoagulant medication
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Study Objectives The purpose of this research study is to test if Axitinib together with Pembrolizumab can slow tumor growth and know the side effects of the combination treatment. Conditions: Alveolar Soft Part Sarcoma, Soft Tissue Sarcomas Intervention / Treatment: DRUG: Axitinib, DRUG: Pembrolizumab
Inclusion Criteria: * Patients must have histologically confirmed sarcoma with pathology review required for any outside samples.* The following histologies may be enrolled without prior treatment: * alveolar soft part sarcoma, * clear cell sarcoma, * epithelioid hemangioendothelioma, and * chordoma.* The following histologies may be enrolled ONLY if refractory to anthracycline-based chemotherapy or if the patient refuses to undergo standard of care treatment: * synovial sarcoma, * rhabdomyosarcoma, * malignant peripheral nerve sheath tumors, * dedifferentiated, pleomorphic or myxoid/round cell liposarcoma, * leiomyosarcoma, * malignant phylloides tumor, * high grade undifferentiated pleomorphic sarcomas (HGUPS/MFH), * angiosarcoma, * spindle cell sarcoma, not otherwise specified (NOS) * malignant myoepithelioma.* The following histologies may be enrolled ONLY if refractory to at least one line of chemotherapy or if the patient refuses to undergo standard of care treatment: * solitary fibrous tumor/hemangiopericytoma.* The following histologies may be enrolled ONLY if refractory to at least first-line targeted therapy or if the patient refuses to undergo standard of care treatment: * gastrointestinal stromal tumors, * extraskeletal myxoid chondrosarcoma, * PEComa.* Primary tumors of bone including Ewing's sarcoma, osteosarcoma, and dedifferentiated chondrosarcoma may only be enrolled if there are measurable target lesions occurring in soft tissue and they are refractory to standard of care anthracycline-based chemotherapy.* Any other histology or standard of care therapy not specifically addressed will be reviewed by the principal investigator and pathologist for final determination of eligibility.* Measurable disease as defined by RECIST v1.1 (provided in Section 14.0).* Radiographic progression as defined by RECIST v1.1, based on comparison between two radiographic studies no greater than 6 months apart.* Inability to undergo complete resection of the disease by surgery.* Adequate organ function as defined: * Hematological * Absolute neutrophil count (ANC) ≥1,000 / microliter (mcL) * Platelets ≥75,000 / mcL * Hemoglobin ≥8 g/dL without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) * Renal * Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN. (GFR can also be used in place of creatinine or CrCl). Creatinine clearance should be calculated per institutional standard. * Hepatic * Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN. * Aspartate Aminotransferase (AST/SGOT) and Alanine Transaminase (ALT/SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases. * Albumin >2.5 mg/dL * Coagulation * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. * Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.* Age ≥ 16 years.* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.* Patients must consent and be willing to undergo three core needle biopsies at baseline, prior to starting Cycle 3, and at off-study. At least one tumor site must be amenable to biopsy in the judgment of the interventional radiologist.* Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.* Females of child bearing potential that are sexually active must agree to either practice 2 medically accepted highly effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 120 days after the last dose of study drug. See Appendix G for protocol-approved highly effective methods of contraceptive combinations. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. * Negative test for pregnancy is required of females of child-bearing potential; A female of child bearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1. has not undergone a hysterectomy or bilateral oophorectomy; or 2. has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months or 730 days). * Conception while on treatment must be avoided* Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Prior history of vasectomy does NOT replace requirement for contraceptive use.* Suitable venous access to allow for all study related blood sampling* Ability to understand and willingness to sign a written informed consent document.* For minors that are 16 to 18 years of age, assent and parental (or legally acceptable representative) written informed consent must be obtained. Exclusion Criteria: * Prior therapy with axitinib. Patients are permitted to have received prior tyrosine kinase inhibitor (TKI) therapy including imatinib, sunitinib, pazopanib, or similar. Patients may have received prior Programmed death 1 (PD-1)/Programmed death-ligand 1 (PD-L1) directed therapy.* Hypersensitivity to axitinib, pembrolizumab or any of its excipients.* Patients may not be receiving any other investigational agents (within 4 weeks prior to Cycle 1, day 1).* Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to Cycle 1, day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.* Patient has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1, Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.* Additional known malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.* Patients with end-organ dysfunction as defined in inclusion criterion (i.e. #11 above).* Patients with bone-only lesions.* Patients with underlying immune deficiency, chronic infections including HIV, hepatitis, or tuberculosis (TB) or autoimmune disease.* Patients with underlying hematologic issues including bleeding diathesis, known previous GI bleeding requiring intervention within the past 6 months, active pulmonary emboli or deep vein thromboses (DVT) that are not stable on anticoagulation regimen.* Has known history of, or any evidence of active, non-infectious pneumonitis.* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.* Concomitant (or receipt of) treatment with medications that may affect the metabolism of pembrolizumab and/or axitinib within 7 days prior to Cycle 1, day 1 of axitinib.* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.* Any uncontrolled, intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia* Prolonged corrected QT (QTc) interval on Screening EKG >475 ms.* Ejection Fraction <40% by 2D echocardiogram (ECHO) at Screening.* Any serious medical or psychiatric illness/condition including substance use disorders likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
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Study Objectives This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes. Conditions: Lung Cancer, Non-Small Cell Intervention / Treatment: DRUG: GSK1120212, DRUG: docetaxel
Inclusion Criteria: * At least 18 years old with histologically- or cytologically-confirmed diagnosis of adenocarcinoma Stage IV NSCLC with a positive mutational status for the KRAS, NRAS, BRAF, or MEK1 gene. * Documented tumor progression after receiving at least one, but not more than one, prior approved platinum-containing chemotherapy regimen for advanced stage/metastatic NSCLC. * Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. * Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. * Life expectancy of at least three months in the opinion of the investigator. * Women of childbearing potential must have a negative serum pregnancy test within 14 days of randomization to study treatment and agree to use effective contraception. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the time of randomization to study medication until at least four weeks after the last dose of study treatment. * Adequate baseline organ function. Exclusion Criteria: * History of another malignancy. * Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures. * Treatment with a BRAF or MEK inhibitor or docetaxel as monotherapy or as part of a combination regimen. * Anti-cancer therapy (including chemotherapy and radiation therapy) within the last three weeks. * History or current evidence / risk of retinal vein occlusion or central serous retinopathy. * Any current or history of tumor manifestation in the Central Nervous System. * History or evidence of cardiovascular risk, including QTcB >=480 msec, uncontrolled arrhythmias, acute coronary syndrome, coronary angioplasty, or stenting within 6 months prior to randomization, >=Class II congestive heart failure, treatment refractory hypertension, intra-cardiac defibrillators or permanent pacemakers or cardiac metastases. * Known Human Immunodeficiency Virus, Hepatitis B Virus (HBV), or Hepatitis C Virus (HBC) infection (with the exception of chronic or cleared HBV and HCV infection).
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Study Objectives Decitabine is a hypomethylating agent that has shown significant anti-leukemic effect in Myelodysplastic Syndrome (MDS) and Acute Myeloblastic Leukemia (AML). This study is based on the hypothesis that Decitabine delivered after allo-hematopoietic stem cell transplant (HSCT) in patients with leukemia will enhance disease control by the allogeneic immune system and lead to a longer disease free survival. The study is designed to provide safety data of low-dosing in the post-transplant setting. Conditions: Leukemia, Lymphoblastic, Acute, Leukemia, Myeloid Acute, Hematopoetic Myelodysplasia Intervention / Treatment: DRUG: Decitabine
Inclusion Criteria: * Age: greater than 1 and less than 31 years of age; * Diagnosis: history of ALL, AML or MDS, currently in a complete remission (CR) following allo-HSCT (bone marrow leukemic blasts less than 5% by morphology), with high risk features including: * Status post allogeneic HSCT * GVHD prophylaxis: * Karnofsky or Lansky performance scores more than 50%. Karnofsky scores will be used for patients > 16 years of age and Lansky scores for patients ≤ 16 years of age; * Platelet count ≥ 50,000 (untransfused); * Absolute neutrophil count ≥ 1000; and; * Hemoglobin ≥ 8 g/dL (un-transfused); Exclusion Criteria: * Progressive disease; * Philadelphia chromosome positive ALL (these patients receive tyrosine kinase inhibitor posttransplant); * Known hypersensitivity to any components of decitabine; * Uncontrolled grade 3-4 graft versus host disease; * Uncontrolled infection; * Serum creatinine > 2 mg/dL or glomerular filtration rate (GFR) less than 60 mL/min/1.73m2 ; * Alanine Aminotransferase (ALT) greater than 3 times normal or serum total bilirubin greater than 2 mg/dL;
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Study Objectives To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator. Conditions: Malignant Melanoma Intervention / Treatment: DRUG: Placebo, DRUG: Vemurafenib, DRUG: Cobimetinib
Inclusion Criteria: * Participants with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition. Unresectability of stage IIIc disease must have confirmation from a surgical oncologist * Participants must be naïve to treatment for locally advanced unresectable or metastatic disease (ie, no prior systemic anti-cancer therapy for advanced disease; stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed * Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test * Measurable disease per RECIST v1.1 * Eastern Clinical Oncology Group performance status of 0 or 1 * Consent to provide archival for biomarker analyses * Consent to undergo tumor biopsies for biomarker analyses * Life expectancy greater than or equal to (≥) 12 weeks * Adequate hematologic and end organ function Exclusion Criteria: * History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase pathway inhibitor treatment * Palliative radiotherapy within 14 days prior to the first dose of study treatment * Major surgery or traumatic injury within 14 days prior to first dose of study treatment * Active malignancy other than melanoma that could potentially interfere with the interpretation of efficacy measures. Participants with a previous malignancy within the past 3 years are excluded except for participants with resected basal cell carcinoma or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast * History of or evidence of retinal pathology on ophthalmological examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion, or neovascular macular degeneration * Uncontrolled glaucoma with intraocular pressure * Serum cholesterol ≥ Grade 2 * Hypertriglyceridemia ≥ Grade 2 * Hyperglycemia (fasting) ≥ Grade 2 * History of clinically significant cardiac dysfunction * Participants with active central nervous system (CNS) lesions (including carcinomatous meningitis) are excluded. However, participants are eligible if: 1. All known CNS lesions have been treated with stereotactic therapy or surgery, AND 2. There has been no evidence of clinical and radiographic disease progression in the CNS for ≥ 3 weeks after radiotherapy or surgery * Current severe, uncontrolled systemic disease * History of malabsorption or other condition that would interfere with absorption of study drugs * Pregnant, lactating, or breast feeding women
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Study Objectives Sun Safe Workplaces (SSW), a comprehensive occupational sun safety program, promoted education and policy to 98 cities, counties, and special districts in Colorado. In a two-year follow-up study, Klein Buendel, Inc. (KB) proposes to examine the effectiveness of SSW on employee sun protection practices by employers and return on investment in an economic evaluation of the cost of the SSW intervention. The results of this follow-up study will provide critical information on effective approaches to increasing sun protection across a wide range of employment sectors with outdoor workers. Conditions: Skin Cancer Intervention / Treatment: BEHAVIORAL: Sun Safe Workplaces Program, BEHAVIORAL: Attention Control
Inclusion Criteria: * Participation in the prior Sun Safe Workplaces: A Campaign on Sun Protection Policies for Outdoor Workers. * A local government organization with employees who worked outdoors in at least one of the following service areas: public works, public safety, and parks and recreation, * Having a full time executive * Having a population of at least 3000 residents * Being employed at a participating local government organization as a manager or employee? * Being employed at a participating local government organization in a job requiring outdoor work at least part of the time. Exclusion Criteria: * Organization had participated in the authors' previous occupational sun protection project.
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Study Objectives The primary aim of this study is: * To determine the overall clinical response rate of weekly Topotecan and Taxotere in women with recurrent ovarian, primary peritoneal, endometrial and uterine cancers. The secondary aims of this study are: * To evaluate the safety and tolerability of the combination therapy with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial or uterine cancers. * To determine the progression free survival and overall survival in women treated with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial and uterine cancers who have been previously treated with chemotherapy and/or radiation therapy. Conditions: Ovarian Neoplasms, Uterine Neoplasms Intervention / Treatment: DRUG: Topotecan and Taxotere
Inclusion Criteria: * Histologically documented recurrent endometrial adenocarcinoma, papillary serous (UPSC), or mixed mullerian tumor (MMT) for which a cure or substantial palliation is unlikely using surgery and/or radiotherapy. Patients must have measurable disease or disease felt to be reproducibly measurable on CT scan, chest x-ray and/or tumor marker elevations . * Recurrent ovarian or primary peritoneal cancers as defined as either: 1. Measurable disease either by physical examination or by imaging or 2. Non-measurable evidence of disease such as any or all of the following standard Rustin criteria: 1. Peritoneal implants <2 cm 2. Abnormal densities on computerized tomography (CT) scan and/or loculated fluid collections 3. Elevated CA-125 (>100 U/mL on 2 measurements at least 1 week apart) and disease- related symptoms. * Patients with the following histologic ovarian or uterine epithelial cell types are eligible: * Serous adenocarcinoma * Endometrioid adenocarcinoma * Mucinous adenocarcinoma * Undifferentiated carcinoma * Clear cell adenocarcinoma * Mixed epithelial carcinoma * Transitional cell * Malignant Brenner's tumor * Adenocarcinoma NOS * Age ≥ 18 years. * ECOG performance status of ≤ 2. * Peripheral neuropathy must be ≤ grade 1 * Previously treated patients must have received no antineoplastic treatment for at least 4 weeks. Patients will not have received more than two previous chemotherapy regimens. * In patients previously irradiated, the recurrent disease should be outside of the radiotherapy portal or have developed disease progression within the radiated field. * No concurrent chemotherapy, radiotherapy, immunotherapy, or hormone therapy. * Hepatic: * Total bilirubin ≤ ULN * AST and ALT and alkaline phosphatase must be within the range allowing for eligibility. * Patients must be alert, oriented, and have signed an informed consent in accordance with institutional policies and be aware of the investigational nature of the study. * Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter Exclusion Criteria: * Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values: 1. Serum creatinine clearance ≤ 50 ml/min 2. Platelets <100,000/mm3 3. Absolute neutrophil count (ANC) <1500/mm3 4. Hemoglobin <8.0 g/dl (the patient may be transfused prior to study entry) * History of chronic or active hepatitis * Patient has severe or uncontrolled medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) * Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at time of study entry. * Patients with a history of severe hypersensitivity to Taxotere®, Topotecan®, or other drugs formulated with polysorbate 80. * Women who are pregnant or breast-feeding
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Study Objectives The objective is to develop an organotypic model to assess the effects of obesity on the expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental fat samples will be removed from participants during surgery and these fat samples will be used in laboratory analyses. Conditions: Endometrial Cancer Intervention / Treatment:
Inclusion Criteria: * Age 18-80 years * Any patient having abdominal surgery (Laparoscopic or open technique) for benign conditions * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patients must have adequate: * Hematologic function: Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L * Renal function: serum creatinine ≤ ULN or estimated glomerular filtration rate (eGFR) \[CKD-EPI Formula\] ≥ 60 mL/min * Hepatic function: serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN * Physically able to undergo surgery * Written informed consent Exclusion Criteria: * Confirmed gynaecological malignancy * Contraindications and/or unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator); * Patients who are pregnant or lactating * Serious illness or medical condition but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (patients with stable AF are eligible), or psychiatric illness/social situations that would limit compliance with study requirements. * Patients with disseminated intra-peritoneal malignancy or suspected ovarian cancer * HIV positive * Previous bariatric surgery
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Study Objectives Metronomic Cyclophosphamide's use in monotherapy as a palliative treatment against non-resectable and metastatic Soft Tissue Sarcomas relies on small retrospective cohorts' data. Current litterature needs external validation of its efficacy and safety profile in these settings of usually frail patients. The investigators assessed further data and aimed to identify predictive factors of metronomic cyclophosphamide impact in metastatic Soft Tissue Sarcomas. Conditions: Sarcoma, Soft Tissue Sarcoma Intervention / Treatment:
Inclusion Criteria: * patients over 18 * with inoperable or metastatic Soft Tissue Sarcoma * treated with Metronomic Cyclophosphamide * in 3 cancer care institutions located in 2 French regions (Bourgogne and Franche-Comté) * between January 2005 and December 2021 Exclusion Criteria: * patients with bone, chondral sarcomas, desmoid, or gastrointestinal stromal tumors
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Study Objectives Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween: * ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and * Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions. Conditions: Lung Cancer Intervention / Treatment: DRUG: Erlotinib HCl 150 mg, DRUG: Tarceva®
Inclusion Criteria: * Healthy, non-smoking, post-menopausal and/or surgically sterile female subjects * Healthy,non-smoking male subjects. Allsubjects willbe from 18 to 55 years ofage. Exclusion Criteria: * Known history or presence of any clinically significant medicalcondition. * Known or suspected carcinoma. * Presence ofclinically significant gastrointestinal disease or history of malabsorption within the last year. * Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption. * Use of tobacco or nicotine-containing products within 6 months priorto drug administration.
36,105
Study Objectives Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia, lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia. Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma Intervention / Treatment: BIOLOGICAL: apolizumab, OTHER: laboratory biomarker analysis, OTHER: pharmacological study
Inclusion Criteria: * One of the following diagnoses: * Histologically confirmed chronic lymphocytic leukemia (CLL) or non-contiguous stage II or stage III-IV small lymphocytic lymphoma (SLL) * Previously treated with at least 1 form of chemotherapy or immunotherapy * Histologically confirmed acute lymphoblastic leukemia (enrolled after the maximum tolerated dose (MTD) is determined) * Must have failed 1 prior therapy * Ineligible for allogeneic stem cell transplantation * Histologically confirmed acute myeloid leukemia (enrolled after the MTD is determined) * Primary refractory or relapsed (within the past year) disease * Ineligible for potential curative therapy * Express Hu1D10 antigen * Greater than 2 times the mean fluorescence intensity of the control by flow cytometry (blood or bone marrow cells) OR * Positive by immunohistochemical staining (lymph node) * Presenting with one of the following indications for treatment unless early bone marrow transplantation is planned (CLL or SLL patients only): * Disease-related progressive symptoms * Progressively worsening anemia or thrombocytopenia * Progressively worsening lymphadenopathy * Massive splenomegaly or hypersplenism * Hyperlymphocytosis (WBC greater than 200,000/mm3) or lymphocyte doubling time less than 12 months * Marrow failure secondary to marrow infiltration by leukemia or lymphoma * Performance status - ECOG 0-2 * At least 2 years * See Disease Characteristics * Platelet count at least 50,000/mm\^3 (without transfusion) * Bilirubin no greater than 3 mg/dL (unless elevated secondary to tumor) * Creatinine no greater than 2.0 mg/dL * No prior decompensated congestive heart failure, unstable angina, or myocardial infarction within the past 6 months not corrected by percutaneous transluminal coronary angioplasty or surgery * No active infection requiring oral or IV antibiotics * No other malignancy that would limit life expectancy * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study * See Disease Characteristics * At least 1 month since prior rituximab or alemtuzumab (unless CD20 or CD52 antigen is expressed on tumor cells) * No prior monoclonal antibody Hu1D10 * See Disease Characteristics
6,248
Study Objectives Study to assess the safety and tolerability of three doses of PBF-509 (80 mg, 160 mg and 240 mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects. Conditions: Parkinson Disease Intervention / Treatment: DRUG: PBF-509, DRUG: Placebo
Inclusion Criteria: * Healthy male or females subjects, 18-45 years (inclusive) of age at the time of enrollment. * Females must be of non-childbearing potential (i.e., surgically sterile) or have to use contraceptive measures (non-hormonal) such as condom, diaphragm or cervical/vault cap with spermicide. Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom/spermicide, in addition to having their female partner use some contraceptive measures. * Clinically acceptable blood pressure and pulse rate in supine and standing position. Blood pressure and pulse will be measured after a minimum of 3 minutes of resting. * Body weight within normal range (Quetelet's index between 19 and 26) expressed as weight (kg) / height (m2). * Able to understand the nature of the study and comply with all their requirements. * Free acceptance to participate in the study by obtains signed informed consent form approved by the Ethics Committee of the Hospital (CEIC). Exclusion Criteria: * History of serious adverse reactions or hypersensitivity to any drug. * Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis). * Background or clinical evidence of chronic diseases. * Acute illness two weeks before drug administration. * Having undergone major surgery during the previous 6 months. * Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication * History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol > 40 g for men or 24 gr/day for women or high consumption of stimulating beverages (> 5 coffees, teas or coca cola drinks/ day) * Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study. * Need of any prescription medication within 14 days prior to the administration of the drug and non prescription medication or herbal medicines within 7 days prior to the administration of the drug. * Participation in other clinical trials during the previous 90 days in which an investigational drug or a commercially available drug was tested. * Having donated blood during 4 weeks period before inclusion in the study. * Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract. * 12 lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥ 120 msec and QTc ≥ 440 msec, bradycardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval. * Symptoms of a significant somatic or mental illness in the four week period preceding drug administration. * History of hepatitis HBV and / or HCV and / or positive serology results which indicate the presence of hepatitis B surface antigen and / or detectable HCV ribonucleic acid (RNA). * Positive results from the HIV serology. * Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation. * Positive results of the drugs at screening period or the day before starting treatment period. A minimum list of drugs that will be screened for include Amphetamines, Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive results may be repeated at the discretion of the Principal Investigator). * Known hypersensitivity to the study drug or the composition of the galenical form. * History of psychiatric diseases or epileptic seizures * Females with positive results from the pregnancy test or breast-feeding.
15,606
Study Objectives To analyze the outcomes of surgical treatment of patients with spinal metastases in spine unit in AUH regarding the pain control, neurological status and ambulatory status as well as survival rate . Conditions: Spinal Metastases Intervention / Treatment: PROCEDURE: spinal decompression
Inclusion Criteria: * Patients > 18 years old * Patient with tissue proven dx of cancer Exclusion Criteria: * Patient younger 18 years old * CNS or spinal 1ry tumor
15,010
Study Objectives The aim of the study was to describe postoperative weight change in adults undergoing surgery for craniopharyngioma and identify preoperative factors associated with it. Conditions: Adult-onset Craniopharyngioma, Postoperative Weight Gain Intervention / Treatment:
Inclusion Criteria: adult-onset, aged 18 years or more; pathologically confirmed craniopharyngioma; primary surgery performed at our hospital; at least 3 months of follow-up including body weight measurement; ambulatory (since lack of ambulation may predispose to weight gain); not receiving supraphysiologic doses of glucocorticoid (e.g. hydrocortisone, prednisone, or dexamethasone to exceed 12mg/m2*d hydrocortisone equivalent) for more than 2 months after tumor therapy. Exclusion Criteria: Childhood-onset, <18 years old; Inconsistent pathology; Without follow-up records in the investigators' institution.
7,850
Study Objectives This phase I trial studies the side effects and best dose of veliparib when given with or without mitomycin C in treating patients with solid tumors that have spread to other places in the body, cannot be removed by surgery or have come back. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib together with mitomycin C may kill more tumor cells. Conditions: Solid Neoplasm Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, DRUG: Mitomycin, DRUG: Veliparib
Inclusion Criteria: * Patients must have a histologically confirmed solid malignancy that is metastatic, or unresectable, or recurrent, for which no curative or standard of care exist, or this standard of care is no longer effective * Tumors have been shown to be deficient for the FA pathway, based on Fanconi anemia triple stain immunofluorescence (FATSI) screening * Patients will be consented to have their existing, or about to be obtained, paraffin embedded tumor tissue screened for FA deficiency; screening will be performed on an ongoing basis on the breast, thoracic, gastrointestinal (GI), Georgetown University (GU), and gynecologic (GYN) Ohio State University (OSU) clinics, anteceding and concurrently with the clinical trial; it will continue until the numbers of patients required for the clinical trial are identified and enrolled; based on the estimation from our preliminary data of 15 to 30% of patients, depending on the primary organ site, having tumors deficient for the FA pathway we will need to screen around 300 patients' samples to identify 40-50 patients; none of the eligibility criteria defined above or below will need to be met for the screening portion, since FA deficient patients identified by screening may meet eligibility criteria for the clinical trial at a later time; (e.g., patient is undergoing standard of care treatment at the time of the screening); separate written consents for screening and for the clinical trial will be obtained from patients * Up to two chemotherapy regimens for metastatic disease are allowed; in addition, prior adjuvant/neo-adjuvant chemotherapy, hormonal therapy, molecular targeted therapy or estrogen receptor B (Erb) inhibitor treatments (e.g., erlotinib, Herceptin, sorafenib, sunitinib) will be allowed and will not count towards eligibility; at least 4 weeks must elapse since prior chemotherapy or radiation therapy (two weeks for erlotinib, hormonal therapy, or limited field palliative radiation to bone, brain, or radiosurgery), 6 weeks if the last regimen included nitrosoureas or mitomycin C; previous use of mitomycin C would be restricted to topical applications (bladder cancer) or chemoembolization (e.g., liver tumors) * Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) * Life expectancy of greater than 3 months * Leukocytes >= 3,000/mcL * Absolute neutrophil count (ANC) >= 1,500/mcL * Hemoglobin >= 9 g/dL * Platelets >= 100,000/mcL * Total bilirubin within normal institutional limit * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 2.5 x institutional upper limit of normal * Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document * Patients should be able to swallow capsules * EXPANSION COHORT: * Diagnosis of colorectal malignancy * Absence of Fanconi anemia, complementation group D2 (FANCD2) foci by FATSI screening * Presence of biopsiable lesion by imaging * Consent to a baseline (prior to treatment) tumor biopsy and for a repeat biopsy at the time of progression on the event that an antitumor response is demonstrated on the MMC-ABT-888 regimen * Same eligibility as above, except that they will have no limitations related prior number of chemotherapy regimens given; patients could have received prior treatment with PARP inhibitors if used as single agent Exclusion Criteria: * Patients may not be receiving any other investigational agents * Patients with known central nervous system (CNS) metastases (unless previously resected or irradiated and not clinically active); patients with CNS metastases must be stable after therapy for > 3 months and off steroid treatment prior to study enrollment * History of allergic reactions attributed to compounds of similar chemical or biologic composition as ABT-888 or Mitomycin C * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible * Patients with active seizure or a history of seizures * Patients previously treated with PARP inhibitors; with the exception of patients enrolled on Arm 2 who may have had prior treatment with PARP inhibitors as monotherapy
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Study Objectives We hypothesize that Guaraná, a native plant from the Amazon, might improve radiation-induced fatigue in breast cancer patients undergoing treatment. In order to assess this, we randomized patients to either guaraná extract or to placebo, switching the assigned treatment mid-term through the radiation. Conditions: Fatigue Intervention / Treatment: DRUG: Guaraná, DRUG: Placebo
Inclusion Criteria: * histological diagnosis of early stage Breast Cancer * 18 years old or older Exclusion Criteria: * prior breast radiation * anemia * clinical depression * unable to sign informed consent
25,602
Study Objectives This is a Phase II, single-arm study in patients with stage IIIB (with malignant pleural effusion) and IV NSCLC who have been previously treated with a platinum-based doublet. Each cycle will be 21 days. On Day 1 of each cycle, patients will receive vinflunine 320 mg/m2 as a 20-minute IV infusion. Patients will continue to receive study treatment until disease progression or unacceptable toxicity. Patients will be evaluated every 2 cycles for response using RECIST criteria. Conditions: Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Vinflunine
Inclusion Criteria: To be eligible for the study, patients must fulfill all of the following criteria: * Patients must have signed an IRB-approved informed consent. * Patients must have recurrent or metastatic stage IIIB (with malignant pleural effusion) and IV NSCLC that has progressed after receiving a platinum-based doublet as first-line therapy. * Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Previously irradiated lesions will not be allowed as measurable disease. * Patients must have an ECOG Performance Status of 0, 1, or 2. * Patients must be <18 years of age. * Previous chemotherapy must have been completed at least 4 weeks prior to enrollment. * Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months. * Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter. * Patients must have an absolute neutrophil count (ANC) >1500/uL, platelet count >100,000/uL, and hemoglobin >8 g/dL. * Patients must have a serum creatinine <2 x institutional upper limit of normal (ULN). * Patients must have a total bilirubin <2.5 x ULN and aspartate transaminase (AST) <5.0 x ULN. Exclusion Criteria: Any of the following criteria will make the patient ineligible to participate in this study: * Patients previously treated with vinflunine or another vinca alkaloid. * Patients with untreated and clinically unstable brain metastases. * Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. * Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection. * Patient has a co-existing malignancy or had a malignancy diagnosed within the last 3 years, with the exception of basal cell carcinoma or cervical cancer in situ. * Patient received treatment with a non-approved or investigational drug within 30 days before planned start of study treatment. * Patient is not completely healed from a previous oncologic or other major surgery. * Patient is receiving or planning to receive any concurrent chemotherapy not indicated in the study protocol or an investigational agent during the study period. * Patients who have a history of hypersensitivity to vinflunine or any of the components in vinflunine or another vinca alkaloid. * Any patient who is pregnant or lactating. * Any patient who is unable to comply with requirements of study.
3,517
Study Objectives Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions). The pathological complete response rate obtained in previous studies is around 12%. The expected pathological complete response rate in this study is 25%. With an alpha error of 0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed initially. With 2 pathological complete responses, patient recruitment will continue until approximately 61 patients are recruited. Twelve pathological complete responses are needed to confirm the study hypothesis. Conditions: Breast Cancer Intervention / Treatment: DRUG: Doxorubicin, DRUG: Cyclophosphamide, DRUG: Docetaxel
Inclusion Criteria: * Written informed consent. * Patients with breast cancer stages II and IIIA, with histological diagnoses as per true-cut or open biopsy. * Negative extension study, including bilateral mammography, thoracic x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy. * Analysis of hormone receptor status in primary tumour. It is highly recommended to obtain a tumour tissue sample before start of treatment, and after definitive surgery. These samples will be analysed centrally by Spanish Breast Cancer Research Group (GEICAM). * Age >= 18 and <= 70 years old. * Performance status as per Karnofsky index >= 80. * Minimum life expectancy of 6 months. * Electrocardiogram (EKG) 12 weeks before registration to the study. If abnormalities are suspected, cardiac function must be assessed by left ventricular ejection fraction (LVEF). * Haematology: neutrophils >= 2.0 x10\^9/l; platelets >= 100 x10\^9/l; hemoglobin >=10 g/dl. * Hepatic function: total bilirubin <= 1 x upper normal limit (UNL); Aspartate aminotransferase (AST) (SGOT) and and Alanine aminotransferase (ALT) (SGPT) <= 2.5 x UNL; alkaline phosphatase <= 5 x UNL. * Renal function: creatinine <= 1.5 x UNL; creatinine clearance >= 60 ml/min. * Patients able to comply with study requirements. * Negative pregnancy test. * Adequate contraceptive method during the study and up to 3 months after definitive surgery. Exclusion Criteria: * Previous systemic therapy for breast cancer treatment. * Previous treatments with anthracyclines or taxanes for any malignancy. * Previous radiotherapy for breast cancer. * Bilateral invasive breast cancer. * Pregnant or lactating women. * Previous motor or sensorial neurotoxicity grade >=2. * Other serious pathologies: congestive heart failure or angina pectoris; history of myocardial infarction in the previous year; uncontrolled hypertension (HT) or high risk arrhythmias. * History of neurological or psychiatric impairment, precluding patients from providing free informed consent. * Active infection. * Active peptic ulcer; unstable diabetes mellitus. * History of previous or current malignancies other than breast cancer, except for basal skin carcinoma, cervical in situ carcinoma, other tumour diagnosed and treated more than 10 years before, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS). * Chronic treatment with corticoids unless the treatment started > 6 months before registration to the study, and low doses are administered. * Substitutive hormonal therapy. This treatment must be interrupted before inclusion in the study. * Concomitant treatment with other investigational products or administration in the 30 previous days. * Males.
16,410
Study Objectives This study aims to determine the effects of adding the Respiratory Distress Symptom Intervention (RDSI) to usual care for the self management of the Respiratory Distress Symptom Cluster (breathlessness-cough-fatigue) for patients with lung cancer including mesothelioma. Conditions: Lung Cancer Intervention / Treatment: OTHER: Respiratory Distress Symptom Intervention
Inclusion Criteria: * A diagnosis of lung cancer - primary tumour, secondary tumour or mesothelioma* Suffering from refractory breathlessness or cough or fatigue (presence of a minimum of two of the three symptoms), and which is bothersome to the patient (see below)\** In the presence of COPD, in stable condition* WHO Performance Status 0-2* Expected prognosis of at least 3 months* 18+ years* able to give informed consent * Patients will be asked as part of the symptom screening process: Are you affected in your day to day life by breathlessness? Are you affected in your day to day life by cough? Are you affected in your day to day life by fatigue? Exclusion Criteria: * Patients who are experiencing breathlessness, cough and/or fatigue but do not find these symptoms bothersome are not eligible (see below)\** Acute exacerbation\*\* of COPD, or chest infection, within the past 3 weeks, necessitating a change in medication* Rapidly worsening breathlessness requiring urgent medical intervention* Post chemotherapy and/or radiotherapy to the chest > 2 weeks* Surgical treatment for lung cancer > 4 weeks * Patients will be asked as part of the symptom screening process: Are you affected in your day to day life by breathlessness? Are you affected in your day to day life by cough? Are you affected in your day to day life by fatigue? \*\* An exacerbation is defined as a sustained worsening of the patient's symptoms from their usual stable state which is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication. NICE guidelines 201025. In this trial, patients will only be excluded if a change in medications were required - i.e. steroids or antibiotics.
33,399
Study Objectives The purpose of this study is to test the safety of gemcitabine and cisplatin plus Everolimus (also called RAD001) at different dose levels. We want to find out what effects, good and/or bad, this treatment has on you and your cancer. Gemcitabine and cisplatin are standard chemotherapy drugs that are commonly used to treat advanced urothelial cancer. Everolimus is a pill that works by shutting down some of the pathways in cancer cells that make tumors grow. Laboratory studies have shown that Everolimus appears to improve the activity of cisplatin against cancer cells. Conditions: Bladder Cancer, Renal Pelvis Cancer, Ureter Cancer Intervention / Treatment: DRUG: gemcitabine and split-dose cisplatin plus escalating doses of continuous Everolimus (RAD001)
Inclusion Criteria: * Patients must have advanced urothelial cancer histologically confirmed by MSKCC pathology review. * Patients may not have received prior systemic chemotherapy for metastatic disease. * Patients may have received prior neoadjuvant or adjuvant systemic chemotherapy provided it was completed ≥ 1 year prior to the diagnosis of metastatic disease. Age ≥ 18 years. * Karnofsky Performance Status ≥ 70. * Expected survival of at least 3 months. * Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade ≤ 1. * Adequate bone marrow function as shown by: * ANC ≥ 1.5x 109/L * Platelets ≥ 100 x 109/L * Hb >9 g/dL Adequate liver function as shown by: * Serum bilirubin ≤ 1.5 x ULN * INR ≤ 1.5 (or < 3 on anticoagulants) * ALT and AST ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases) Adequate renal function as shown by: * Serum creatinine ≤ 2.0 mg/dL OR Calculated creatinine clearance ≥ 50 mL/min/1.73 m2 using the Jelliffe equation: Calculated creatinine clearance = 98 - 0.8 \[age(yrs) - 20\] x (0.9 if female) Serum creatinine (mg/dL) * Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: If a patient's lipid values exceed either one of these criteria upon screening, the patient can only become eligible after successful initiation of appropriate lipid-lowering medication. After lipid-lowering therapy, patients must meet the same criteria - i.e. a fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN - to be eligible for study treatment. * Testing for hepatitis B viral load and serological markers (HBV-DNA, HBsAg, HBsAb, and HBcAb) for the following patients: * All patients who currently live in (or have lived in) Asia, Africa, Central and South America, Eastern Europe, Spain, Portugal, or Greece * Patients with any of the following risk factors: * Known or suspected past hepatitis B infection * Blood transfusion(s) prior to 1990 * Current or prior IV drug users * Current or prior dialysis * Household contact with hepatitis B infected person(s) * Current or prior high-risk sexual activity * Body piercing or tattoos * Mother known to have hepatitis B * History suggestive of hepatitis B infection, e.g dark urine, jaundice, or right upper quadrant pain * Additional patients at the discretion of the investigator * Testing for hepatitis C infection (using quantitative RNA-PCR) for patients with any of the following risk factors: * Known or suspected past hepatitis C infection (including patients with past interferon "curative" treatment) * Blood transfusion(s) prior to 1990 * Current or prior IV drug users * Household contact of hepatitis C infected person(s) * Current or prior high-risk sexual activity * Body piercing or tattoos * Additional patients at the discretion of the investigator Exclusion Criteria: * Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, tyrosine kinase inhibitors, etc.). * Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients who may require major surgery during the course of the study. * Prior treatment with any investigational drug within the preceding 4 weeks. * Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg. Patients receiving these corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior to the first treatment with Everolimus. Topical or inhaled corticosteroids are allowed. * Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period. * Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases. * Evidence of another active cancer, except for non-melanoma skin carcinoma, in-situ carcinoma of the cervix curatively treated, and adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA that is non-detectable. * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: symptomatic congestive heart failure of New York Heart Association Class III or IV. * Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease. * Severely impaired lung function as evidenced by: * TLC <50% predicted OR * FVC <50% predicted OR * DLCO <40% predicted * Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN. * Active (acute or chronic) or uncontrolled severe infections. * Liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis. * A known history of HIV seropositivity. * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of Everolimus (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). * Patients with an active, bleeding diathesis. * Female patients who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to administration of Everolimus. * Adults of reproductive potential who are not using effective birth control methods. Men and women of childbearing potential must be willing to use effective barrier method contraception during the trial and for at least 6 months thereafter. Patients are encouraged to continue barrier method contraception for two years or longer after treatment. Hormonal contraceptives are not acceptable as a sole method of contraception. * Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus). * Patients with a known hypersensitivity to Everolimus (RAD001) or other rapamycins (sirolimus, temsirolimus) or to its excipients. * Patients with a history of noncompliance to medical regimens. * Patients unwilling to or unable to comply with the protocol.
11,925
Study Objectives This phase II trial is studying how well cediranib maleate works in treating patients with relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic syndrome. Cediranib maleate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Adult Acute Myeloid Leukemia Intervention / Treatment: DRUG: cediranib maleate, OTHER: laboratory biomarker analysis
Inclusion Criteria: * Histologically or cytologically confirmed acute myeloid leukemia (AML) ormyelodysplastic syndromes meeting 1 of the following criteria: * Relapsed AML meeting any of the following criteria: * Good-risk cytogenetics (inv\[16\], t\[8;21\], or t\[15;17\]) in second orgreater relapse * Patients with AML t(15;17) must have failed prior tretinoin and arsenic-containing regimens AND progressed orrelapsed within 12 months of therapy * In first or greater relapse * Resistant AML * Unable to achieve first complete remission after at least 2 inductionregimens * Untreated AML meeting any of the following criteria: * At least 60 years of age * Preceding MDS * MDS * International Prognosis Scoring System (IPSS) risk groupof intermediate-2 or higher * Patients with relapsed disease after allogeneic hematopoietic stem cell transplantation (HSCT) must be off allimmunosuppressive medications for at least 30 days and have no symptoms orsigns of graft-vs-host disease * No active CNS metastasis * Patients with clinical signs of CNS disease or a history of CNS diseasewithin the past 6 months are required to undergo lumbar puncture to excludeCNS involvement * No symptomatic leukostasis or requirement for leukapheresis * Not eligible for allogeneic HSCTAND no suitable donor at the time of study entry * Patients who areeligible for HSCT, informed of the option, and choose not to proceed to HSCTare allowed * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Bilirubin normal * AST and/or ALT ≤ 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance ≥ 60 mL/min * No proteinuria ≥ 1+ on 2 consecutive urinalysis taken ≥ 1 week apart * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No HIV positivity * LVEF ≥ 45% by echocardiography * Mean QTc ≤ 500 msec (with Bazett's correction) * No other significant ECG abnormality * No history of familial long QT syndrome * No disseminated intravascular coagulation * No history of allergic reactions attributed to compounds of similar chemical orbiological composition to AZD2171 * No concurrent uncontrolled illness, including, but not limited to, any of the following: * Hypertension * Thyroid disease * Ongoing or active infection * Symptomatic congestive heartfailure * Unstable angina pectoris * Cardiac arrhythmia * NYHA class III-IV heart disease * NYHA class II heart disease controlled with treatment allowed * Psychiatric illness or social situations that would limit study compliance * See Disease Characteristics * More than 4 weeks since prior chemotherapy (6 weeks fornitrosoureas or mitomycin C), radiotherapy, or major surgery and recovered * Hydroxyurea allowed to control peripheral blast count> 20,000/mcL prior to study entry and during the first 3 days of study therapy * More than 4 weeks since prior and no concurrent growth factor or other cytokine support * At least 30 days since prior investigational agents or participation in aninvestigational trial * No more than 3 prior courses of induction chemotherapy * Induction chemotherapyis defined as that intended to induce complete remission and given at a time thatthe patient has active disease * No concurrent CYP interactive medications * No other concurrent investigational agents * No concurrent drugs or biologics with proarrhythmic potential * Prior and concurrent hydroxyurea allowed to control peripheral blast count> 20,000/mcL during the first 3 days of study therapy
10,990
Study Objectives This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients. Conditions: Secondary Hyperparathyroidism Intervention / Treatment: DRUG: cinacalcet, DRUG: control
Inclusion Criteria: * Peritoneal dialysis patients with secondary HPT(iPTH > 300 pg/mL) * > 18 yr of age, < 70 * had receive PD for > 3 mo, * intact PTH level > 300 pg/ml and <1000 pg/ml * albumin corrected Ca level >= 9.0 mg/dL Exclusion Criteria: * pregnant or breast-feeding, * had undergone parathyroidectomy within previous 3 mo, * are involved in other clinical trial within 30 d * had received cinacalcet therapy previously.
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Study Objectives The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT. Conditions: Prostate Cancer Intervention / Treatment: BEHAVIORAL: Exercise
Inclusion Criteria: * men aged 50 years or older * diagnosed with adenocarcinoma prostate cancer * will initiate and receive continuous ADT (luteinizing hormone releasing hormone agonist (LHRH) or combination of LHRH and anti-androgen) for at least 12 months after recruitment * Patients will also consent to participating in the study. Exclusion Criteria: * severe cardiac disease (New York Heart Association class III or greater) * angina * severe osteoporosis * uncontrolled hypertension (blood pressure > 160/95mm Hg) * orthostatic blood pressure drop > 20mm Hg * moderate to severe aortic stenosis * acute illness or fever * uncontrolled atrial or ventricular dysrhythmias * uncontrolled sinus tachycardia (> 120 beats per minute) * uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness, severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, pathological lower limb fractures within 6 months, lower limb amputation).
2,361
Study Objectives RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The patient's stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with or without total-body irradiation followed by a stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma. Conditions: Lymphoma Intervention / Treatment: DRUG: carmustine, DRUG: cyclophosphamide, DRUG: etoposide, PROCEDURE: autologous hematopoietic stem cell transplantation, PROCEDURE: peripheral blood stem cell transplantation, RADIATION: total-body irradiation, DRUG: G-CSF
Inclusion Criteria: * DISEASE CHARACTERISTICS: * Biopsy-proven diagnosis of high-grade (small noncleaved cell lymphoma \[SNCCL\] or immunoblastic lymphoma) or intermediate-grade non-Hodgkin lymphoma (NHL) including mantle cell lymphoma (MCL) * SNCCL patients with all of the following factors at presentation of disease: * Lactate dehydrogenase (LDH) > 500 IU/L * Unresectable bulky mass > 10 cm * Stage IV disease with bone marrow involvement * MCL Patients with stage IV disease or in International Prognostic Index (IPI) high- or high-intermediate-risk group at the time of diagnosis * Considered at diagnosis to be high- (3 risk factors) or high-intermediate-risk (2 risk factors) based on an age-adjusted IPI * Poor prognostic factors at diagnosis include stage III or IV disease, lactate dehydrogenase (LDH) level above normal, or ECOG performance status (PS) 2-4 * Patients with primary mediastinal large cell lymphoma with or without sclerosis who at diagnosis had elevated LDH level with bulky mediastinal mass > 10 cm associated with a pleural effusion on chest radiography or computer tomography, or who have persistent mediastinal mass with positive disease by post-treatment gallium GA 67 scan * Must have attained a complete response or partial response to first-line standard conventional chemotherapy * ECOG PS 0-1 OR Karnofsky PS 80-100% * Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min * FEV_1 > 65% of predicted measurement or DLCO ≥ 45% of predicted measurement * Cardiac ejection fraction > 50% by echocardiogram * Bilirubin ≤ 1.5 x normal * SGOT or SGPT ≤ 2 x normal Exclusion Criteria: * Evidence of lymphoma or < 10% lymphomatous involvement of bone by bilateral bone marrow aspiration and biopsy * Abnormal cytogenetic study of bone marrow aspirate sample NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. * Positive HIV antibody * Prior malignancies except for adequately treated basal cell or squamous cell carcinoma of the skin * Hepatitis B surface antigen positivity * Prior bone marrow transplantation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior bone marrow transplantation
3,480
Study Objectives This study aimed to assess efficacy of ArtiSential® in reducing laparoscopic rectal cancer surgery duration. We retrospectively reviewed the data of patients who underwent laparoscopic low or ultralow anterior resection for primary mid-to-low rectal cancer, performed by a single surgeon in 2012-2022. Patients were divided into groups, use group vs. non-use group, based on the use or non-use of the ArtiSential®. The total mesorectal excision quality and resection margin status did not differ between the groups. ArtiSential® reduced operative time without impairing surgical quality or oncologic outcomes. Conditions: Rectal Cancer Intervention / Treatment: DEVICE: ArtiSential®
Inclusion Criteria: * mid-to-low rectal caner (witing 10cm of the anal verge) * laparoscopic surgery Exclusion Criteria: * combined surgery * recurrent rectal cancer surgery
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Study Objectives To address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect CTCs in cancer patients. In order to facilitate the validation process, investigators will only focus on metastatic patients for whom CTCs supposedly present at higher abundance. Investigators propose to enroll cohorts of metastatic breast cancer patients. Blood samples will be collected from these patients before they start any new line of therapy as determined by their doctors. The specific aims are to isolate, enumerate and analyze the number and/or molecular information of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging, and molecular profiling techniques. Investigators will use this study to optimize diagnostic instrumentation, test blood processing protocols and CTC analysis algorithm. During this study investigators will collect patients' clinical information related to cancer, as well as the patients' survival status to validate the system's prognosis ability. Conditions: Circulating Tumor Cells (CTCs) Intervention / Treatment:
Inclusion Criteria: * Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.* Progressive and measurable metastatic breast cancer.* Commencement of new anti-cancer chemotherapy or palliative care.* ECOG performance status equal or less than grade 2. Exclusion Criteria: * Subject has received any investigational agent, not explicitly approved by MiCareo, within last one year.* Subject being identified with any blood borne infectious disease.* Subject has received anticancer chemotherapy within last one month. (not including hormone therapy, or target therapy)* Pregnancy.
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Study Objectives Primary Objectives: 1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups. 2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups. Secondary Objectives: 1. To determine the degree of expression of various adhesion molecules in the 2 groups and correlate with time to engraftment of neutrophils, platelets, and red blood cells, efficacy of stem cell mobilization and purging. 2. To determine the incidence of disease progression/relapse at 12 months in the two groups. Conditions: Lymphoma Intervention / Treatment: DRUG: Etoposide, DRUG: G-CSF, DRUG: GM-CSF, DRUG: Isophosphamide, DRUG: Rituximab, PROCEDURE: Apheresis
Inclusion Criteria: * Patients with histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma who are candidates for autologous stem cell transplantation.* Age up to 70 years* Platelet count > 100,000 mm3, independent of transfusion support* Absolute neutrophil count (ANC) > 1500/mm3* Zubrod performance status of 2 or less.* Negative pregnancy test in women* Less than 10% marrow involvement with lymphoma within 4 weeks of study enrollment as defined by bilateral bone marrow aspirations and biopsies.* Should be seronegative for HIV, HTLV, hepatitis B surface antigen, hepatitis C antibody. Exclusion Criteria: * Clinical or radiographic evidence of active CNS disease* Severe concomitant medical or psychiatric illness* Lactating or breast feeding females* Less than 3 weeks from the first day of last chemotherapy* Prior myeloablative therapy with autologous bone marrow or stem cell rescue* Serum bilirubin > 1.5 X ULN, Serum transaminases > 2XULN.* Serum creatinine >1.6 mg/dl* History of pelvic radiation* Patients should not have received more than 3 prior chemotherapy regimens (excluding radiation)* Patients should not have received more than 6 cycles of fludarabine therapy
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Study Objectives A study to evaluate efficacy and safety of TheraSphere and resection combination therapy in patients with single large ((\> 5cm, long diameter ) hepatocellular carcinoma : Conditions: Carcinoma, Hepatocellular Intervention / Treatment: DEVICE: Theraspere
Inclusion Criteria: * Signed written informed consent* Clinical or histological diagnosis of HCC based on the guidelines of the American Association for the Study of Liver Diseases (AASLD).* Single large (> 5cm, long diameter) lesion that is typically enhanced\* and bi-dimensionally measurable by multiphasic spiral CT scan and dynamic contrast-enhanced MRI.* Tumor conditions confirmed by abdominal imaging (contrast enhanced CT ± MRI) performed within 28 days prior to the enrollment* Age of at least 19 years.* ECOG Performance Status of 0.* Child-Pugh class A (Child-Pugh score ≤6).* Life expectancy of at least 16 weeks.* Patients with bile duct involvement can be enrolled if patients have adequate bone marrow, liver, and renal function* Adequate bone marrow, liver as assessed by the following laboratory requirements (no transfusion, no restoration), conducted screening: Data can be used within 28 days of screening. * Hemoglobin ≥ 8.0g/dL * Absolute neutrophil count (ANC) ≥ 1,000/mm3 * Platelet count ≥ 100,000/μL * Total bilirubin ≤ 2mg/dL * Serum albumin ≥ 3g/dL * ALT and AST < 5 × upper limit of normal * PT-INR ≤ 1.7* Patients with involvement with tumor thrombus in the second-order branches of the portal vein or distal to the second-order branches (Vp1-Vp2) can be enrolled if operability is confirmed by the surgeon. Exclusion Criteria: * Diffuse infiltrative tumor type* Presence of separate daughter nodule* Poorly defined and/or mixed-irregular tumor margin* Definitive combined HCC-cholangiocarcinoma on images* A history of receiving any systemic therapy of the molecularly targeted agents, immunotherapy, external beam radiation to the liver or cytotoxic chemotherapy for the treatment of HCC* Presence of extrahepatic HCC: Involvement of vessels \[major branch of hepatic vein invasion; major branch of portal vein invasion from the first order portal vein branch (Vp3) to main portal vein (Vp4)\]; lymph node, metastasis* History or presence of hepatic encephalopathy* Ascites, moderate, large or intractable* Active clinically serious infections (> grade 2, NCI-CTCAE version 4.02), including spontaneous bacterial peritonitis.* Untreated active chronic hepatitis B* Esophageal or gastric varices ≥ F2 (grade 2) with red color sign positive without prophylaxis (non-selective beta-blocker or endoscopic variceal ligation) or history of variceal bleeding without endoscopic variceal ligation/ injection sclerosis* Active ulcer of stomach or duodenum: untreated or presence of visible vessel* Any major surgery within 4 weeks, or any minor surgery within 2 weeks prior to signing the informed consent form* Candidate for liver transplantation and/or a history of liver transplantation* History of cardiac diseases: congestive heart failure greater than NYHA class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); uncontrolled hypertension and diabetes mellitus* History of AIDS/HIV infection* Seizure disorder requiring medication (such as steroids or anti-epileptics)* History of organ allograft* Evidence or history of bleeding diathesis, or thromboembolic events requiring treatment* Current renal dialysis* Previous or concurrent cancer that has a primary site or histology distinct from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis, and T1\] or any cancer curatively treated less than 3 years prior to enrollment.* (Deleted)* Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques.* Shunting of blood to the lungs that could result in delivery of greater than 16.5 mCi of yttrium-90 to the lungs. Radiation pneumonitis has been seen in patients receiving doses to the lungs greater than 30 Gy in a single treatment.* Hepatic artery catheterization is contraindicated; such as patients with vascular abnormalities or bleeding diathesis.* Severe liver dysfunction or pulmonary insufficiency* Pregnant or breast feeding women, or impossible to use of reliable methods of contraception* Subject who the investigator deems inappropriate to participate in this study
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Study Objectives Metabolic and Molecular Response evaluation for the individualization of therapy in adenocarcinomas of the gastroesophageal junction by evaluation of the R0 resection rate for patients with metabolically (ie, according to PET criteria) chemotherapy-resistant locally advanced AEG, who receive an intensified neoadjuvant chemoradiotherapy (INRCT). Additonal efforts will be done by investigation of molecular and metabolic biomarkers in relation to their predictive and prognostic value by correlating them with histopathologic responses and clinical outcome in an exploratory approach. Conditions: Adenocarcinoma of the Esophagogastric Junction Intervention / Treatment: DRUG: Oxaliplatin, DRUG: Epirubicin, DRUG: Capecitabine, DRUG: 5-FU, DRUG: Carboplatin, DRUG: Paclitaxel, RADIATION: radiation, PROCEDURE: Biopsy
Inclusion Criteria: * Histologically confirmed AEG I-III * Potentially R0 - resectable AEG and primary tumor category UT2 -4 * Functional operability : Exclusion of OP - limiting comorbidities * Intense FDG tracer uptake of the tumor during Baseline PET/CT examination and thus suitability for monitoring and early response prediction by FDG - PET ( \[ 18F \] - FDG uptake in the tumor at baseline > 1.35 x liver SUV + 2 x standard deviation of the liver SUV) * Performance status (ECOG ) 0 or 1 * Age : ≥ 18 * creatinine clearance > 60ml/min measured in a 24 h urine or calculated with the Cockgroft -Gault formula * bilirubin ≤ 1.5 times upper limit of normal , serum transaminases (GOT / GPT ) ≤ 3 times ULN * leukocytes ≥ 3.5 g / l, platelet ≥ 100 g / l * Negative pregnancy test (determination of beta- HCG in urine or serum) in women of childbearing potential * A signed consent form after implementation of medical education Exclusion Criteria: * Existing distant metastases (M1b) * Tumor infiltration into the tracheobronchial system * Previous radiotherapy targeted at the thorax * Lack of ability of the patient to adhere to the protocol rules * Manifest heart failure despite optimal medication> NYHA I * existing angina pectoris at rest or undergoing stress without clarification via interventional cardiology and / or myocardial infarction within the last 6 months * Existing pregnancy or lactation * childbearing or fertility without using recognized safe methods of contraception * Coexisting other malignant diseases with the exception of a non-melanomatuous, localized skin tumor or carcinoma in situ of the cervix * absence of a signed consent form
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Study Objectives This study is being conducted to characterize the safety/tolerability of pazopanib and lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients with recurrent Grade III or IV malignant gliomas. Conditions: Glioma Intervention / Treatment: DRUG: pazopanib, DRUG: lapatinib
Inclusion criteria: Phase I * Patients are on EIAC for a minimum of 15 days. Patients may be on more than one anti-convulsant (AC). At least one of the ACs must be an EIAC. * Patients with anaplastic astrocytoma, anaplastic oligodendroglioma, mixed anaplastic oligoastrocytoma, glioblastoma multiforme, or gliosarcoma at recurrence * Patients whose diagnostic pathology confirmed these pathologies will not need re-biopsy * Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to Grade III or IV malignant glioma Phase II * Patients must have histologically confirmed glioblastoma multiforme or gliosarcoma in first or second recurrence. * Patients may not have received more than two prior cytotoxic chemotherapy containing regimen. * Patients must not have received prior treatment with VEGFR, ErbB1, ErbB2 inhibitors including but not limited to PTK-787, Sorafenib, Sutent, Tarceva, Iressa, Erbitux, and Herceptin. Prior Avastin therapy is permitted provided three months has elapsed before Day 1, Treatment Period 1. * Tumor tissue must be analyzed for PTEN and epidermal growth factor receptor (EGFR) vIII prior to dosing. * Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to Grade IV malignant glioma. * Patients must not be on an EIAC. NOTE: Once the (optimally tolerated regimen) OTR in Phase I is determined and all patients in the expanded cohort have completed 1 treatment period then patients on EIAC may be enrolled in the Phase II component of the study. Phase I and II * Male or female, age at least 18 years of age. * Eastern Cooperative Oncology Group (ECOG) status 0 to 1 as per protocol. * Clinical lab results as per protocol * Has a left ventricular ejection fraction (LVEF) at least 50% based on echocardiogram (ECHO) or Multi Gated Aquisition (MUGA) or within the institutional normal range. * Adequate renal function * Creatinine clearance more than 50 mL/min as calculated by the Cockcroft-Gault formula as per protocol. * Urine Protein Creatinine (UPC) ratio of less than or equal to 1 as per protocol. * Able to swallow and retain oral medications. * A woman is eligible to enter and participate in the study if she is of: - Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who: * Has had a hysterectomy, * Has had a bilateral oophorectomy (ovariectomy), * Has had a bilateral tubal ligation, * Is post-menopausal (total cessation of menses for at least 1 year) - Childbearing potential, has a negative serum pregnancy test at screening, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: * An intrauterine device (IUD) with a documented failure rate of less than 1% per year. * Vasectomized partner who is sterile prior to the female patient's entry and is the sole sexual partner for that female. * Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide). * A man with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study. * If sexually active, patients will continue the recommended contraceptive measures for the duration of the treatments and for 28 days following discontinuation of therapy. * Signed informed consent approved by the Institutional Review Board prior to patient entry. Exclusion criteria: * Poorly controlled hypertension as per protocol. NOTE: Initiation or adjustment of BP medication is permitted prior to study entry provided that patient has two consecutive BP readings less than 140/90 mmHg each separated by a minimum of 24 hrs. These readings need to be collected prior to enrolment. * Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive cardiac failure, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease, or active uncontrolled infection) that could compromise participation in the study. * History of myocardial infarction, admission for unstable angina, cardiac angioplasty or stenting within three months of Day 1, Treatment Period 1. * Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system as per protocol. * QTc prolongation defined as a corrected QT (QTc) interval greater than or equal to 470 milliseconds. * History of venous or arterial thrombosis within 3 months of Day 1, Treatment Period 1. * Current use of therapeutic warfarin. NOTE: both low molecular weight heparin and prophylactic low-dose warfarin are permitted; however, prothrombin time/partial thromboplastin time (PT/PTT) must meet above inclusion criteria. * Excessive risk of bleeding as defined by stroke within the prior 6 months, history of central nervous system (CNS) or intraocular bleed, or septic endocarditis. * Evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post-operative Grade 1 hemorrhage. * Active systemic bleeding, such as gastrointestinal bleeding or gross hematuria. * Female patients who are pregnant or breast feeding. * Acute or chronic liver disease (i.e., hepatitis, cirrhosis). * Patients who received investigational drugs less than 21days prior to Day 1, Treatment Period 1, or who have not recovered from the toxic effects of such therapy. * Patients who received chemotherapy less than or equal to 21days prior (6 weeks for prior nitrosourea or mitomycin C) to Day 1, Treatment Period 1, or who have not recovered from the toxic effects of such therapy. * Patients who received radiation therapy less than or equal to 12 weeks prior to Day 1, Treatment Period 1, or who have not recovered from the toxic effects of such therapy as per protocol. * Patients who received biologic, immunotherapeutic or cytostatic agents less than or equal to 14 days prior to Day 1, Treatment Period 1, or who have not recovered from the toxic effects of such therapy. * Patient is less than 3 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant or requiring active intervention. Patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. * Surgical resection of brain tumor or any other surgery less than or equal to 21 days prior to Day 1, Treatment Period 1, or who have not recovered from side effects of such a procedure. Patients who undergo stereotactic biopsy less than or equal to 14 days prior to Day 1 of Treatment Period 1, or who have not recovered from side effects of such a procedure. * Patients with any Grade of intraparenchymal CNS hemorrhage. Exceptions include Grade 1 intraparenchymal hemorrhage in the immediate post-operative period, or Grade 1 intraparenchymal hemorrhage that has been stable for at least 3 months. * Patients unwilling to or unable to comply with the protocol. * Any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with patient safety or obtaining informed consent. * History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism or excretion of study drugs. Has any unresolved bowel obstruction or diarrhea. * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. * Is on any specifically prohibited medication or requires any of these medications during treatment.
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Study Objectives Smokers will complete questionnaires and smoking behaviour will be examined. After abstaining from smoking for approximately 18 hours, they will be randomized to a moderate intensity exercise group or passive sitting group. Smoking behaviour (time to first puff) will be assessed following treatment. Conditions: Cancer Intervention / Treatment: BEHAVIORAL: Moderate Exercise Group, BEHAVIORAL: Passive Sitting Group
Inclusion Criteria: * 18 to 64 years of age * Smoke 10 cigarettes or more per day * Not have any medical condition that is contraindicative for exercise * Not be pregnant or intending on being pregnant over the course of the study * Be able to read and write in English * Have a telephone or an email account so that they can be contacted * Completed the Physical Activity Readiness Questionnaire (PAR-Q) * Have Medical Doctor's clearance if they answer "YES" to one or more questions on the Physical Activity Readiness Questionnaire (PAR-Q) * Have not been engaged in a serious quit attempt in the last six months * Have been smoking for more than 2 years * Must not be suffering from an illness (e.g. cold) that would affect their typical smoking behaviour Exclusion Criteria: * Contraindication to exercise (e.g., disability, unstable angina) * On medication for physical and/or mental health reasons that would make compliance with the study protocol difficult or dangerous * Have substance dependency problems (e.g., alcohol) * Are pregnant * Be younger than 18 years of age * Be 64 years or older prior to completion of the study * Have been engaged in a serious quit attempt in the last six months * Have been smoking for less than 2 years * Suffering from an illness (e.g. cold) that would affect their typical smoking behaviour
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Study Objectives Gastric outlet obstruction in malignant disease appears when the tumor affects the gastroduodenal area, precluding the passage of food into the small bowel. This condition severely affects the quality of life. In patients with unresectable tumors, there are various available treatments:a surgical bypass connecting the stomach to the small bowel, placing a stent through the tumor to widen the passage and creating a gastrointestinal bypass with a lumen apposing metal stent. These stents are deployed with an echoendoscope, which allows to identify a small bowel loop and to deploy the stent, connecting the small bowel and the stomach. This is called a EUS-guided gastroenterostomy (EUS-GE). EUS-GE is a rather novel procedure. Various techniques to create EUS-GE have been proposed. In this study, the investigators will retrieve data from the procedure and during the thirty following days from consecutive patients undergoing an EUS-GE. The objectives of the study are: * To perform a detailed step by step description of the nasobiliary drain assisted EUS-GE * To describe the adverse events encountered * To describe the proportion of clinical and technical success * To assess its impact on the patients' quality of life. * To assess the evolution of the oral intake during the first month after the procedure Conditions: Gastric Outlet Obstruction, Gastric Cancer, Pancreatic Cancer Intervention / Treatment: DEVICE: EUS-guided gastroenterostomy
Inclusion Criteria: * Patients over 18 years of age * unresectable malignant gastric outlet obstruction * Undergoing placement of nasobiliary drain assisted EUS-GE Exclusion Criteria: * Previous gastroduodenal surgery * Previous endoscopic or surgical treatment for gastric outlet obstruction * Simultaneous biliary obstruction (malignant or benign) requiring endoscopic treatment * Simultaneous upper digestive tract disease requiring endoscopic treatment in the same procedure * Unable to understand the questionnaires * Distal bowel obstruction * Ascites grade 2 or superior * Uncorrectable coagulation disorders (INR>1,5) or severe thrombocytopenia (<50000 platelets/mm3). * Active, symptomatic SARS-CoV-2 infection
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Study Objectives The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed with AML and unfit for intensive chemotherapy. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: GRASPA
Inclusion criteria: * Patient > 65 years old and < 85 years old * Newly diagnosed Acute Myeloid Leukemia (AML) or post myelodysplastic syndrome diagnosed within 6 months prior to study enrollment * Unfit for intensive chemotherapy (at risk to suffer treatment related pejorative toxicities /early death) due to the presence of one or more of the following criteria: Dependence in activities of daily living owing to the presence of comorbidities other than those resulting from the deterioration caused by the neoplastic disease. Presence in the patient's medical history of three or more of the following comorbidities, even if they are under control with proper treatment: Congestive heart failure, other chronic cardiovascular diseases, chronic obstructive pulmonary disease, cerebrovascular disease, peripheral neuropathy, chronic kidney failure, hypertension, diabetes mellitus, systemic vasculitis, severe arthritis * Presence of geriatric syndromes such as fecal or urinary incontinence, spontaneous bone fractures, mild and moderate dementia, or patients who fall repeatedly, or, patient unwilling to receive intensive chemotherapy * Eligible to receive low-dose cytarabine treatment * ECOG performance status ≤ 2 * Female patients of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 6 months after the last dose of Cytarabine or 3 months after last dose of GRASPA (whichever is the longest). * Negative serum pregnancy test at study entry for female subjects of childbearing potential * Subscription to social security insurance (if applicable, in accordance with local regulations) * Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion criteria: * Patients with M3 AML of FAB classification (APL, acute promyelocytic leukemia) * Patients with AML involving chromosome 16 abnormalities or translocation (8:21) (CBF-AML) * Patient with secondary AML subsequent to prior malignant blood disorder such as: Myelodysplastic syndrome diagnosed more than 6 months before study entry or Myeloproliferative syndrome * Prior therapy to AML (standard therapy or investigational agents) * Inadequate organ function : Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, Serum creatinine concentration > 2 x ULN (Upper Limit of Normal), AST or ALT levels > 3.5xULN or 5xULN if related to AML, Total bilirubin > 2 x ULN, INR > 1.5, unless patient under chronic treatment with anticoagulants (in this case, INR should be within expected ranges for the specific condition), Insulin-dependent or uncontrolled diabetes mellitus * Concurrent malignancies other than AML requiring chemotherapy * Severe active infection, HIV seropositivity, or known active type B or C viral hepatitis * Known or suspected hypersensitivity or intolerance to mannitol * Breastfeeding or lactating women
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Study Objectives The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast conservation in breast cancer patients for the last 4 decades. It is also a routine practice in UK and few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation help the radiation centers worldwide to meet the growing need for radiation in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study the investigators want to reduce the treatment duration from 3 weeks to 2 weeks. The study will include 20 patients with breast cancer post mastectomy or after breast conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2 weeks. Patients will be assessed for acute radiation toxicity weekly during treatment and after one month of completion of treatment. Conditions: Breast Cancer Intervention / Treatment: RADIATION: Hypofractionation
Inclusion Criteria: * invasive carcinoma of the breast * breast conservation surgery or mastectomy (reconstruction allowed but not with implant. Tissue expanders with distant metal ports are allowed) * axillary staging \&/or dissection * complete microscopic excision of primary tumour * pT1-3 pN0-2 M0 disease * written informed consent * able to comply with follow up N.B. Concurrent trastuzumab and hormone therapy is allowed Exclusion Criteria: * past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or (ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free * contralateral breast cancer, including DCIS, irrespective of date of diagnosis * breast reconstruction using implants * concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
2,201
Study Objectives This early phase I trial studies giving propranolol hydrochloride with standard chemotherapy in treating patients with ovarian, primary peritoneal, or fallopian tube cancer. Biological therapies, such as propranolol hydrochloride, blocks certain chemicals that affect the heart and this may stimulate the immune system and allow the chemotherapy to kill more tumor cells. Conditions: Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Fallopian Tube Undifferentiated Carcinoma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Undifferentiated Carcinoma, Primary Peritoneal Serous Adenocarcinoma, Stage II Fallopian Tube Cancer AJCC v6 and v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage IIA Fallopian Tube Cancer AJCC v6 and v7, Stage IIA Ovarian Cancer AJCC V6 and v7, Stage IIB Fallopian Tube Cancer AJCC v6 and v7, Stage IIB Ovarian Cancer AJCC v6 and v7, Stage IIC Fallopian Tube Cancer AJCC v6 and v7, Stage IIC Ovarian Cancer AJCC v6 and v7, Stage III Fallopian Tube Cancer AJCC v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIB Ovarian Cancer AJCC v6 and v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IIIC Ovarian Cancer AJCC v6 and v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7 Intervention / Treatment: DRUG: Chemotherapy, DRUG: Propranolol Hydrochloride, OTHER: Quality-of-Life Assessment, PROCEDURE: Therapeutic Conventional Surgery
Inclusion Criteria: * Suspected preoperative diagnosis of invasive epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer based on imaging and cancer antigen (Ca) 125; histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified; patients with primarily carcinoma histology but mixed features can be included; the surgically confirmed histologic features must be compatible with primary Mullerian epithelial adenocarcinoma * Stages II-IV of the above cancer * Patients to be scheduled for a planned tumor debulking * Intention for chemotherapy administration at MD Anderson Cancer Center * Zubrod performance status 0-2 * Absolute neutrophil count (ANC) >= 1500/ml * Platelets > 100,000/mL * Creatinine clearance (CrCl) > 50 mL/min * Bilirubin =< 1.5 x institutional upper limit normal * Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x institutional upper limit normal * Alkaline phosphatase =< 2.5 x institutional upper limit normal * Neuropathy (sensory and motor) =< grade 1 according to Common Toxicity Criteria for Adverse Events version 3 (CTCAE) * Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for the management of venous thrombosis including pulmonary embolus) * Partial thromboplastin time (PTT) < 1.2 times institutional upper limit of normal * Pulse >= 60 beat per minute (bpm) * Systolic blood pressure (SBP) > 110 mmHg; diastolic blood pressure (DBP) >= 60 mmHg * Normotensive individuals not already on beta blockers (may be on other anti hypertensives): SBP =< 140, DBP =< 90 * Surgery or neoadjuvant chemotherapy must be scheduled at least 72 hours in advance in order for the patient to take at least 48 hours of prescribed propranolol and have stable vital signs confirmed * An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian * Patients of childbearing age must have a negative pregnancy test * Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal, or fallopian tube cancer Exclusion Criteria: * Patients with non-epithelial ovarian tumors that do not require adjuvant chemotherapy, borderline epithelial ovarian tumor, or recurrent invasive epithelial ovarian, low grade ovarian cancer, primary peritoneal, or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB); patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated new invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer are eligible, provided that they have not received chemotherapy for any tumor; no stromal cancers or germ cell cancers or low malignant potential; patients found post operatively to have ineligible histology will be removed from the study * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation therapy for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease * Patients with a synchronous primary endometrial cancer, or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than stage IA; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions * Patients who have received targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their primary peritoneal, ovarian, or fallopian tube cancer * With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded * Metastases to the ovaries from other organs except fallopian tube or primary peritoneal carcinoma * Use of systemic glucocorticoids such as prednisone or Decadron in the last month * Inability to accurately answer questions (e.g. dementia, brain metastases) or speak English or Spanish * Cirrhosis of the liver * Patients with a Zubrod performance status 3 or 4 * Comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV), lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis * Any patients already on beta-blockers or contraindicated to receive beta-blockers * Hypersensitivity to propranolol, or beta-blockers * Uncompensated congestive heart failure * Cardiogenic shock * Severe sinus bradycardia; heart block, second or third degree or sick sinus syndrome (if no artificial pacemaker present) * Severe hyperactive airway disease (chronic obstructive pulmonary disease, asthma) * Any patients planning to receive Avastin or any other anti-angiogenic drugs * Patients with brittle diabetes mellitus (DM); brittle diabetes mellitus is a type of diabetes when a person's blood glucose (sugar) level often swings quickly from high to low and from low to high; also called "unstable diabetes" or "labile diabetes"
17,646
Study Objectives the increase in the serum PSA (prostate specific antigen) value following radical treatment commonly involves subsequent treatment which, in the absence of morphological evidence of disease recovery, is conducted empirically through local radiotherapy or systemic hormonal therapy. The use of PET with choline is therefore of extreme clinical interest as it allows to identify the site of disease recurrence, thus being able to direct towards a specific therapeutic treatment. The diagnostic accuracy of choline PET in identifying the location of the disease has been widely demonstrated in the literature and is comparable to those of conventional diagnostic methods previously described for the restaging of patients with prostatic disease. The real advantage of this method is the possibility of obtaining the same information as conventional methods by carrying out a single exam. Conditions: Prostate Cancer Intervention / Treatment: DIAGNOSTIC_TEST: Diagnostic accuracy
Inclusion Criteria: * adult patients suffering from prostate cancer who have undergone choline PET/TC Exclusion Criteria: * patients < 18 years
36,602
Study Objectives The purpose of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naïve participants with non-metastatic prostate cancer. Conditions: Hormone Treatment-naïve Participants With Prostate Cancer Intervention / Treatment: DRUG: TAK-385
Inclusion Criteria: * Participants judged by the investigator to have the capacity to understand the study and follow the study rules.* Participants whose written consent (signature or printed name and personal seal on informed consent form) can be obtained before any study procedures are performed.* Japanese male participants 20 or more years of age at the time of informed consent.* Participants who, if they have a female partner who could become pregnant, agree to practice appropriate means of contraception from the time of informed consent throughout the entire study treatment period and for 4 months after the last dose of study drug.* Participants in stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks (28 days) prior to study treatment initiation.* Participants with histologically or cytologically confirmed prostate cancer.* Participants whose clinical diagnosis is T1-4 N0 M0, or Tx N0 M0 for participants who have undergone radical prostatectomy.* Participants who are considered eligible for hormone therapy for prostate cancer.* Participants who have not received hormone therapy (example, gonadotropin-releasing hormone \[GnRH\] agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer.* Participants who have not undergone surgical castration.* Participants with serum testosterone at screening greater than (>) 150 nanogram per deciliter (ng/dL).* Participants meeting either of the following criteria for prostate-specific antigen (PSA) at screening. Untreated prostate cancer: PSA at screening > 4.0 nanogram per milliliter (ng/mL) Treated\* prostate cancer: PSA at screening > 0.2 ng/mL. * Participants who have undergone prostatectomy or either or both of high intensity focused ultrasound therapy or radiotherapy (excluding 125I-brachytherapy) prior to the start of this study.* Eastern Cooperative Oncology Group (ECOG) Performance Status \[17\] of 0 or 1.* Body mass index (BMI) at screening greater than or equal to (>=) 18.0 kilogram per square meter (kg/m\^2). Exclusion Criteria: * Participants exhibiting symptoms judged related to prostate cancer by the investigator (example, bone pain, pelvic pain, ureteral obstruction) who urgently require hormone therapy such as GnRH agonist, GnRH antagonist, or CAB/MAB therapy, chemotherapy, or radiotherapy.* Participants who have received 5-alpha reductase inhibitors (except for participants who have been treated for male-pattern alopecias).* Participants who have received chemotherapy for prostate cancer (including estramustine).* Participants who have received 125I-brachytherapy.* Participants who received radiotherapy (except for 125I-brachytherapy) within 16 weeks (112 days) before study treatment initiation.* Participants who underwent prostatectomy within 16 weeks (112 days before study treatment initiation.* Treatment with any investigational compound within the 4 weeks (28 days) prior to the first dose of study drug or ongoing participation in another experimental trial related to the treatment of prostate cancer.* Diagnosis or treatment for another systemic malignancy within 2 years before study treatment initiation, or who had received a diagnosis of another malignancy before that and have evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ who have undergone complete resection will not be excluded from the study.* Participants taking drugs with moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitory or inducing effects, or any medications, supplements, or food products with P-glycoprotein (P-gp) inhibitory effects, in the 2 weeks (14 days) prior to study treatment initiation.* Participants who have received TAK-385 in a past clinical study.* Participants for whom it would be difficult to collect blood from a peripheral vein.* Participants with uncontrolled and clinically significant nervous, circulatory, pulmonary, hepatic, renal, metabolic, gastrointestinal, urogenital, or endocrine disorders, or other abnormalities (except for the targeted disease) that could affect study participation or the study results. Also, participants meeting any of criteria a through c below. A. Participants with uncontrolled diabetes (Hemoglobin A1c \[HbA1C\] > 8 percent \[%\] at screening). However, participants whose HbA1c is brought under control with diabetes medications may be rescreened. B. Participants with uncontrolled hypertension (systolic blood pressure > 150 millimeter of mercury (mmHg) and diastolic blood pressure > 90 mmHg at 2 separate measurements taken no more than 60 minutes apart at screening). Participants whose blood pressure is brought under control by antihypertensive medication may be rescreened. C. Participants with myocardial infarction, unstable symptomatic ischemic heart disease, arrhythmias of common terminology criteria for adverse events (CTCAE) Grade > 2, thromboembolism (deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or other heart diseases (example, pericardial effusion, restrictive cardiomyopathy). However, chronic stable atrial fibrillation controlled by stable anticoagulant therapy will be allowed.* Participants with bilateral hydronephrosis or bladder neck outlet obstruction.* Known hypersensitivity to TAK-385, TAK-385 excipients, or gonadotropin-releasing hormone (GnRH) antagonists.* Participants with a past history of gastrointestinal tract treatments (including gastrectomy) or gastrointestinal disease that could affect the drug absorption or tolerability (malabsorption, esophageal reflux, peptic ulcer, erosive esophagitis).* Participants positive for hepatitis B surface antigens (HBsAg), hepatitis C antibodies (HCV), human immunodeficiency virus (HIV) antibodies, or serologic test for syphilis, or with life-threatening disease other than cancer, at screening.* Clinically relevant electrocardiogram (ECG) abnormalities, or the following ECG abnormalities, at screening. * Q-wave infarction, unless identified 6 or more months prior to TAK-385 treatment initiation. * QTcF interval > 450 millisecond (msec) (when calculating the QTc interval, Fridericia's equation \[QT/RR0.33\] will be used).* Participants with congenital QT prolongation.* Current use of Class 1A or Class 3 antiarrhythmic medications.* New York Heart Association Class III or IV heart failure.* Participants with clinical laboratory abnormalities suggesting clinically relevant underlying disease, or with any of the following abnormal results, at screening. * Serum creatinine >= 2.0 mg/dL. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 1.5\*upper limit of normal (ULN) for the study site. * Total bilirubin >= 2\*ULN for the study site. * Neutrophil count less than (<) 1,500 per cubic millimeter (/mm\^3), platelet count < 100,000 per microliter (/mcL), hemoglobin < 10.0 g/dL. * Results of heart-related tests (creatine kinase MB \[CK-MB\] and cardiac troponin T) exceeding the study sites reference value.* Participants found to have clinical problems on the basis of examination findings, ECG findings, or chest X-ray findings at screening.* Participants considered unlikely by investigators to be able to follow the study protocol or considered ineligible for the study by investigators for other reasons.
24,603
Study Objectives This is a controlled trial of the Mini-AFTERc intervention to reduce fears of recurrence in breast cancer patients. The sample will be collected in NHS Fife Breast Cancer Services (n=32). The intervention is a short telephone counseling service of 20 minutes delivered by the patient's breast cancer specialist nurse. Dependent measures consist of the ACCRE FoR 4 item measure and the EORTC Intervention overall satisfaction scale. Conditions: Fear Intervention / Treatment: BEHAVIORAL: Mini-AFTERc, BEHAVIORAL: telephone call
Inclusion Criteria: * breast cancer patient completed treatment * female Exclusion Criteria: * psychiatric illness * cognitive deficit (e.g. dementia) * no access to telephone
18,046
Study Objectives This study is a retrospective real-world study. In this study, we plan to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab . Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma Intervention / Treatment: DRUG: nimotuzumab
Inclusion Criteria: * Age ≥18 years old, no gender limitation; * Histopathologically or cytologically proved to be phase III-IVb of head and neck squamous cell carcinomas (including oral cancer, oropharynx cancer, hypopharynx cancer, larynx cancer, but except for nasopharyngeal carcinoma). * Patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018; * Patients in the study group received nimotuzumab, while patients in the control group did not receive nimotuzumab. And patients in the control group were collected 3 times as many cases as the study group in each center. If the number of patients in the control group were less than 3 times of the study group, all cases were collected. Exclusion Criteria: * Complicated with primary malignancies other than head and neck tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); * Patients received other targeted therapy, immunotherapy, or Traditional Chinese medicine with anti-tumor effect, along with the application of nimotuzumab; * Lack of critical evaluation information.
4,982
Study Objectives Solitary pulmonary nodule has become a major challenge in respiratory clinical practice. According to published guidelines, their management often requires close CT follow up, PET CT and invasive procedures to obtain a definite histology. In this context, innovative endoscopic techniques refered as navigational bronchoscopy have proved to be efficient, for the localization and sampling of peripheral lung nodules. However, these techniques are unable to differentiate malignant lesions from benign ones, in-vivo, in real time. Confocal endo-microscopy (CELLVIZIO) of the distal lung - also refered as distal lung probe based confocal laser endo-microscopy or alveolar lung endo-microscopy - allows in-vivo imaging of the distal lung structures in real time. This prospective trial we will assess confocal endoscopy as a tool to localize the peripheral lung nodules and to differentiate benign from tumoral lesions. Objective(s) 1. To demonstrate that confocal endo-microscopy is not inferior to navigational endoscopy for the localisation of peripheral lung nodule 2. To demonstrate that confocal endoscopy can differentiate benign from malignant tumors Experimental design: Multicentric prospective controlled trial, conducted in three academic centers, specialized in interventional bronchoscopy, equipped with both navigational bronchoscopy and probe based confocal endo-microscopy. Subjects with peripheral lung nodule requiring navigational bronchoscopy will be explored using both Confocal endoscopy AND navigational bronchoscopy. Confocal probe will be inserted in the same catheter as used for the navigational bronchoscopy and confocal images will be recorded before sampling. An ancillary study using topical methylene blue as in situ will be conducted at the Rouen University Center. An ancillary protocol includes the use of in situ methylene blue deposition and 660 confocal endo-microscopy analysis. Conditions: Pulmonary Nodule Persistent, Malignant Neoplasm of the Respiratory System, Benign Neoplasms of the Respiratory System Intervention / Treatment: DEVICE: confocal endo-microscopy
Inclusion Criteria: * Patients with a peripheral lung nodule accessible by navigational bronchoscopy and CELLVIZIO according to Investigator evaluation of the CT scan. * 18 years old or more. * Affiliation to french social security insurance. * Signed informed consent for the procedure. Exclusion Criteria: * Severe respiratory insufficiency that will not allow the bronchoscopy procedure * Uncorrected bleeding disorders * History of pneumonectomy or exploration controlateral to a non functional lung, * Pregnant or breast feeding woman, or person not authorized to participate to a clinical trial according to L1121-6 et L1121-8 of French Code of Public Health, concurrent participation to another clinical trial
9,153
Study Objectives This is a continuation of a pilot study which is now regarded as a phase II trial with a plan to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT). Conditions: Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndromes, Multiple Myeloma, Non-Hodgkins Lymphoma, Hodgkins Disease, Peripheral T-cell Lymphoma Intervention / Treatment: DRUG: Pentostatin, RADIATION: Total-body irradiation (TBI), DRUG: Cyclosporine A (CsA), DRUG: Mycophenolate Mofetil (MMF), DRUG: G-CSF
Inclusion Criteria: Age 19-75 years * Patients who relapse after autologous stem cell transplantation.* Patients who are candidates for an autologous or conventional allogeneic stem cell transplantation from a disease standpoint but who do not qualify functionally (from the point of view of organ function, or performance status) for a myeloablative protocol.* Any patient, where in the opinion of the primary treating oncologist, nonmyleoablative therapy would be the treatment option in the best patients interest providing the patient fits all other eligibility criteria for this protocol. Identification of a matched related or unrelated stem cell donor Diseases: Acute myelogenous leukemia first complete remission with high-risk cytogenetics>second complete remission minimal residual disease (<10% blasts\*). Acute lymphocytic leukemia first complete remission with high-risk cytogenetics >second complete remission minimal residual disease (<10% blasts\*). Chronic myelogenous leukemia first chronic phase, accelerated phase (<10% blasts\*)blast phase with minimal residual disease (<10% blasts\*)second chronic phase. Chronic lymphocytic leukemia recurrence after the front line regimen (related donor transplant), chemorefractory disease (unrelated donor transplant),T-CLL in partial remission or any minimal residual disease. Myelodysplastic syndromes refractory anemia with or without ringed sideroblasts,RAEB, RAEB-T, and CMML (< than 10% blasts\*). \*both in peripheral blood and bone marrow Multiple myeloma - after receiving at least one regimen of prior chemotherapy Non-Hodgkin's Lymphomas: Small Lympho(plasma)cytic Lymphoma (B-SLL, B-LPL): recurrence after a front line regimen (related donor transplant), or chemorefractory disease (related or unrelated donor transplant). Follicular Low-Grade Lymphoma, Marginal Zone Lymphomas (splenic, nodal, or extranodal/MALT type): chemorefractory disease or > 2 prior regimens. Mantle Cell Lymphoma: first complete or partial remission, refractory disease, or failed prior ASCT. Diffuse Large B-cell Lymphoma, Follicular Large cell Lymphoma, Peripheral T-cell Lymphoma, Anaplastic Large Cell Lymphoma: refractory disease, or failed prior ASCT. Burkitt or Acute Lymphoblastic Lymphomas: high-risk disease in remission, chemosensitive persistent or recurrent disease. Cutaneous T-cell Lymphomas: (Mycosis Fungoides, Sezary Syndrome): chemorefractory disease of > 2 prior regimens Hodgkins Disease: refractory or persistent disease and not candidate for ASCT, or failed prior ASCT. Peripheral T-cell Lymphoma Exclusion Criteria: * Age > 75 years and < 19 years * progressive disease within 8 weeks of prior therapy or within 12 weeks after prior autologous stem cell transplantation * Active CNS malignancy (patients with known positive CSF cytology or parenchymal lesions visible by CT or MRI) * Fertile men or women unwilling to use appropriate contraceptive techniques during and for 12 months following treatment * Females who are pregnant * Patients who are HIV seropositive * Active uncontrolled infection or immediate life-threatening condition at the time of enrollment * Significant Organ dysfunction: 1. Calculated Creatinine Clearance <55ml/min 2. cardiac ejection fraction <40%, NYHA class II or greater cardiac disease. 3. DLCO < 40% , FEV1/FVC ratio <50% predicted, or receiving supplementary continuous oxygen 4. total bilirubin > 2x upper limit of normal (unless due to Gilberts disease or malignancy), ALT and AST 4x the upper limit of normal * Karnofsky score <60% * Patients with uncontrolled medical illnesses (e.g., uncontrolled systemic hypertension, diabetes) Donor Inclusion Criteria: * HLA genotypically matched relative * siblings or first-degree relatives matched at HLA-A, B, or DR loci (6 antigen match) are acceptable donors * HLA matched unrelated volunteer donor * unrelated donor matched at HLA-A, B, or DR loci (6 antigen match) are acceptable donors * One antigen mismatch related or unrelated donor will also be acceptable, molecular typing needs to be used at each H LA-A, B, or DR loci in case of mismatched unrelated donor. Donor Exclusion Criteria: * Identical twin * Pregnancy * HIV positive * Serious Allergy to G-CSF * Current serious systemic illness * Failure to meet the UNMC or NMDP criteria for donors
1,655
Study Objectives The aim of the present prospective study was to assess dysphagia (occurrence, severity, length) in head and neck cancer (HNC), from diagnosis to 18 months after their first line treatment regardless of the treatment. The investigators have complied with the pre-listed clusters. For this purpose, pursuant to consensus on the dysphagia assessment, the investigators used the Deglutition Handicap Index (DHI) questionnaire (Silbergleit 2012) for dysphagia screening and patient's self-perception. This was the only questionnaire validated in French evaluating the swallowing function by the patient (Woizard 2006). Clinical evaluation according to NCI-CTCAE v4.0 criteria and objective measures of swallowing function were also recorded and compared to DHI results. Conditions: Dysphagia Intervention / Treatment:
Inclusion Criteria: * Patient must have an initial confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. * Patient has to be aged ≥ 18 * Patient has to be able to complete questionnaire in French * Patient must benefit from health insurance * Patient must sign an informed consent form * Patient treatment must be validated in a medical multidisciplinary team meeting: surgery, radiotherapy (RT), chemotherapy (CT), radiochemotherapy (RTCT), induction chemotherapy followed by radiochemotherapy (IND+RTCT), surgery followed by radiotherapy (surgery+RT), surgery followed by radiochemotherapy (surgery+RTCT). Exclusion Criteria: * - Patients treated with prior systemic chemotherapy, radiation therapy or surgery on head and neck area * Pregnant or breast-feeding women
23,577
Study Objectives The purpose of this study was to determine attitudes regarding the 2009 USPSTF Guidelines for breast cancer screening for women in their 40's and assess the effect of one of two newspaper articles on their attitudes. The population studied was women seeing their private gynecologist for annual exams in the 39-49 year old age group. Conditions: Attitude, Practice Guideline, Breast Cancer Intervention / Treatment: OTHER: read unfavorable article prior to answering questions, OTHER: read favorable article prior to answering questions
Inclusion Criteria: * women aged 39-49 seeing their gynecologist for routine preventive care Exclusion Criteria: * women not aged 39-49 * women with breast cancer * women not able to read English
38,195
Study Objectives Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. It is worth noting that acute postoperative pain may play a vital role in central sensitization and up-regulation of pain receptors, even factors implicated in the development of CPSP. According to previous studies, the incidence of postoperative pain among patients undergoing spinal surgery was nearly 80%. At the same time, perioperative pain management of patients undergoing spinal surgery has not been clearly. For the past few years, pregabalin and esketamine are becoming important roles in perioperative pain management, lots of studies have shown that these two analgesics might relieve postoperative pain. The aim of this study was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after spinal cord neoplasms resection, so as to find a better way to help the patients undergoing spinal surgery keep away from the acute perioperative pain. Conditions: Esketamine, Pregabalin, Acute Postoperative Pain, Neurosurgical Procedures, Perioperative Complication, Spinal Cord Neoplasms Intervention / Treatment: DRUG: S-ketamine and pregabalin, DRUG: Normal saline and placebo capsule
Inclusion Criteria: * Patient undergoing elective spinal cord neoplasms resection; * Ages between 18 and 65 years old; * American Society of Anaesthesiology (ASA) status I-III; * Signed informed consent. Exclusion Criteria: * Previous adverse reaction to ketamine, s-ketamine or pregabalin; * Patients with a diagnosed history of severe chronic pain; * Patients with long-term analgesic treatment(gabapentin/opioids/ketamine); * Patients with aphasia or inability to cooperate with the pain assessments; * Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure); * Patients with a diagnosed history of psychiatric disorder; * Patients treated with gabapentin/pregabalin in the last three months; * Drug abuse; * Body mass index (BMI) > 35 kg/m2 ; * Pregnancy or lactation.
12,179
Study Objectives This study evaluates the safety as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages IIIc and IV). Conditions: Metastatic Melanoma Intervention / Treatment: BIOLOGICAL: Melanoma antigens-specific CD8+ T lymphocytes
Inclusion Criteria: * Male or female ≥ 18 and ≤ 75 years * Patient expressing the HLA-A\*0201 subtype of the human leukocyte antigen (HLA -A2) * Patient with metastatic melanoma stage IIIc or IV (AJCC 2010) except brain metastases * Tumor expressing the antigens Melan-A and MELOE-1 detected by RT-PCR * Absence of cerebral metastases * ECOG ≤ 1 or Karnofsky ≥ 80% * Prior adjuvant melanoma treatment (before metastatic stage) authorized (anti- BRAF, anti-CTLA4, IFN, TIL... ) * Disease measurable / evaluable within 28 days before the first administration of study treatment * Negative viral serology (HIV 1/2, Ag p24 , HTLV 1/2 , hepatitis B and C, syphilis) * Results of analysis: * Hemoglobin ≥ 10 g / dl or ≥ 6.25 mmol / l * Leukocytes ≥ 4000/μl * Lymphocytes ≥ 1500/μl * Platelets ≥ 80.000/μl * Creatinine ≤ 2.5 N * Total bilirubin ≤ 3 N * AST and ALT ≤ 3 N without liver metastases; ≤ 5 N with liver metastases * Negative pregnancy test for women of childbearing age * Patient affiliated to a social security system * Patient who has signed informed consent Exclusion Criteria: * Brain metastases * Ocular primitive melanoma * Treatment of metastatic melanoma by more than two lines (chemotherapy , immunotherapy, targeted therapy or radiotherapy) or within 4 weeks before the inclusion * Treatment with ipilimumab within 8 weeks before the inclusion * Known allergy to albumin * Contraindication to the use of vasopressors * Positive viral serology for HIV 1/2 , Ag p24 , HTLV 1/2, hepatitis B or C, or syphilis * Women who are pregnant, nursing or refusing to use contraceptives, women with no negative pregnancy test at baseline * Presence of a second active cancer (with the exception of cervical cancer in situ or skin cancer other than melanoma) * History of event or current event of a progressive or non-stabilized severe heart disease (congestive heart failure, coronary artery disease, uncontrolled hypertension, serious arrhythmias or ECG signs of previous myocardial infarction) * Uncontrolled thyroid dysfunction * Any serious acute or chronic illness (active infection requiring antibiotics, bleeding disorders or other condition requiring concomitant treatment not allowed in this study) * History of chronic autoimmune disease (Addison's disease, multiple sclerosis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, ... ) with the exception of patients with active vitiligo or a history of vitiligo * History of uveitis and retinopathy associated with melanoma * Adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")
25,808
Study Objectives No prospective randomized trials have evaluated the most efficacious dose of cyclophosphamide to mobilize autologous stem cells. We previously demonstrated that the time to collection of autologous hematopoietic stem cells is 10-12 days following the one dose of cyclophosphamide and daily G-CSF (granulocyte-colony stimulating factor).9 This prospective randomized trial is designed to determine if a lower dose of cyclophosphamide (1.5 gm/m2) will be as efficacious as the intermediate dose (3 gm/m2), based on cell number collected, number of apheresis required and resource utilization. Conditions: Hematologic Malignancies Intervention / Treatment: DRUG: Cyclophosphamide
Inclusion Criteria: * All patients must have a pathologic diagnosis of one of the following malignancies: Non-Hodgkin's Lymphoma, including B- and T-cell lymphoma Multiple Myeloma or another plasma cell dyscrasia (Waldenstrom, Amyloidosis) * The patient must be approved for transplant by the treating Transplant physician. * This must be the patient's FIRST mobilization attempt. * Patients are eligible if an autologous transplant is planned within approximately 12 months from the time of collection of cells. * Prior Treatment: No previous cytotoxic chemotherapy within 4 weeks prior to initiation of therapy. (This does not include immunomodulatory drugs (IMiDs), proteasome inhibitors, monoclonal antibodies or steroids.) * No radiation within 4 weeks of mobilization attempt. * Age >18, and < 75 years * No significant co-morbid medical or psychiatric illness that would significantly compromise the patient's clinical care and chances of survival. * Informed consent must be signed prior to the treatment. Patients must willingly consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side effects, risks and discomforts. (Human protection committee approval of this protocol and a consent form is required.) Exclusion Criteria: * Medical, social, or psychological factors that would prevent the patient from receiving or cooperating with the full course of therapy. * Documented hypersensitivity to any of the drugs used in the protocol.
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Study Objectives The goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer. The effect that this combination treatment has on the tumor will also be studied. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Bevacizumab, DRUG: Capecitabine, RADIATION: Radiotherapy
Inclusion Criteria: * Cytology or histologic proof of adenocarcinoma of the pancreatic head, body or tail prior to treatment. * Patients with nonmetastatic, unresectable, disease are eligible. * Patients with regional nodal disease are eligible. * Karnofsky performance status >=70. * No upper age restriction. * Absolute granulocyte count >1,500 cells/mm3 and platelet count at least 100,000 cells/mm3. * Serum bilirubin less than 5mg/dl prior to the start of therapy with adequate biliary decompression. * Adequate bilateral renal function. * Serum creatinine <1.5 mg/dl. * Adequate liver function; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST)<=5 times upper limit of normal. * Sexually active men must practice contraception during study. * Patients must sign study-specific consent form. Exclusion Criteria: * History or evidence upon physical examination of CNS disease. * Active infection requiring parenteral antibiotics on Day 0. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study. * Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent. * Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medications. * Pregnancy or lactation. * Proteinuria at baseline or impairment of renal function. * Serious, nonhealing wound, ulcer, or bone fracture. * Evidence of bleeding diathesis or coagulopathy * Clinically significant cardiovascular disease, congestive heart failure, serous cardiac arrhythmia requiring medication, or significant peripheral vascular disease within 1 year prior to Day 0. * History of aneurysms, strokes, transient ischemic attacks, and arteriovenous malformations. * Serous concomitant medical or psychiatric disorders. * Cohort receiving Capecitabine
12,832
Study Objectives To determined what dose of topotecan can be safely given with daily pazopanib. Conditions: Solid Tumours Intervention / Treatment: DRUG: topotecan, DRUG: pazopanib
Inclusion Criteria - * signed, written informed consent. * at least 18 years of age. * ECOG performance status 0 or 1. * Subjects must have histologically or cytologically confirmed diagnosis of advanced cancer and a solid tumor malignancy that has relapsed or is refractory to standard therapy or for which there is no established therapy. * able to swallow and retain oral medications. * females are eligible to enter and participate in this study providing adequate established contraception is being practiced. Exclusion Criteria * had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) * received an investigational drug within 30 days or 5 half-lives (whichever is longer). * received prior treatment with pazopanib/investigational anti-angiogenic compounds. * presence of uncontrolled infection. * pregnant or lactating. * poorly controlled hypertension (SBP of ? 140 mmHg, or DBP of ? 90 mmHg. * Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.- * arterial thrombi, myocardial infarction, admission for unstable angina, uncontrolled or symptomatic arrhythmia, cardiac angioplasty, or stenting within the last 6 months. * any unresolved bowel obstruction or diarrhea ? Grade 1. * received an allogeneic bone marrow transplant. * known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or topotecan. * any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study. * psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. * clinical history, current alcohol or illicit drug use which, in the judgment of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
19,951
Study Objectives Objective: To compare the efficacy of cryotherapy using liquid nitrogen (cryoget method) versus trichloroacetic acid 90% (applicator method) in treatment of common warts. Study Design: Randomized Control Trial. Place And Duration of Study: Department of Dermatology, CMH Abbottabad from Jun 2022 to Nov, 2022. Conditions: Warts Intervention / Treatment: DRUG: CRYOTHERAPY, DRUG: Tricholoracetic acid
Inclusion Criteria: * Patient presented with common warts in dermatology opd Exclusion Criteria: * * Patients with warts on toes and tip of fingers * genital warts * cardiac, hepatic and renal disease * hypercholesterolemia * hypersensitivity reactions
32,305
Study Objectives This protocol corresponds to a prospective, multicentre, open label, phase II study designed to evaluate the efficacy of CPX-351 in elderly patients with secondary or high-risk AML. The clinical trial is divided into pre-treatment, treatment (induction and consolidation cycles) and follow-up periods and consists of a single arm group. Patients will be enrolled at diagnosis to follow the treatment arm. After that will start induction chemotherapy with CPX-351 regimen (14 days maximum screening period). Once a patient have been evaluated for response and recovered from major complications, he/she will start second course (consolidation 1), unless the bone marrow and peripheral blood assessment is showing less than a complete response, then a second induction may be offered. If a CR or CRi is obtained after the second induction course, patients will start the third course after a rest and recovery period. Patients aged between 60 and 65 years old are recommended to undergo an allo-SCT after first consolidation if they are considered fit for this procedure and they have a full matched related or unrelated donor. Patients aged between 65 and 70 years old can be proposed for an allo-SCT in CR/CRi if they have a composite HSCT co-morbidity index /age less than 4 and a suitable fully matched related donor. In patients over 70 years old, an allo-SCT in first CR should be avoided although the decision should be taken on an individual basis. Patients with CR/CRi who are not considered for an allo-SCT, will follow 6 maintenance cycles with modified courses of CPX-351 schedule. Patients showing unacceptable toxicity along all therapeutic phases that, in consideration of the investigator, will be prematurely discontinued. All patients will be followed-up for survival. The study will be analyzed on an intention to treat basis. Bone marrow and response assessments will be done after each induction and consolidation course, and every 3 months during the first 12 months after starting maintenance therapy. Patients will be followed-up for a minimum period of 1 year after the enrolment of the last patient. Additionally, after the end of the trial, patients will be followed-up for 2 years in order to verify survival and the evolution of the disease. Study design allows a maximum of 59 patients. Conditions: Newly Diagnosed Secondary or High Risk AML Intervention / Treatment: DRUG: CPX-351
Inclusion Criteria: * Written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. Informed consent form must be signed by the patient and the investigator.* Age 60 to 75 years at the time of diagnosis of AML.* Newly confirmed diagnosed of AML according to WHO 2008 criteria.* Secondary or high risk AML, defined as one of the following: * t-AML: documentation of prior cytotoxic therapy or radiation therapy for an unrelated disease in a discharge summary or pharmacy records or radiation therapy records * MDSAML: bone marrow documentation of MDS prior to diagnosis of AML (could have been treated previously with hypomethylating or standard chemotherapy) * CMMoLAML: bone marrow documentation of CMMoL prior to diagnosis of AML (could have been treated previously with hypomethylating or standard chemotherapy) * de novoAML with FISH or cytogenetic changes linked to MDS per WHO 2016 criteria.* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.* Ability to adhere to the study visit schedule and other protocol requirements.* Laboratory values fulfilling the following: * Serum creatinine < 2.0 mg/mL * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin < 3 times the upper limit of normal (ULN, subjects with elevated liver enzymes related to disease were instructed to contact the Sponsor) (subjects with Gilbert's Syndrome were instructed to contact the sponsor).* Subjects with second malignancies in remission may have been eligible if there was clinical evidence of disease stability for a period ≥ 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies at screening. Subjects maintained on long-term nonchemotherapy treatment such as hormonal therapy were eligible.* Cardiac ejection fraction ≥ 50% assessed by echocardiography or MUGA.* Eligible to receive intensive chemotherapy.* Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception for three months after their last dose of medication. Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential).* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures Exclusion Criteria: * Patients with genetic diagnosis of acute promyelocytic leukemia.* Age <60 years or >75 years.* Blastic phase of bcr/abl chronic myeloid leukemia.* Patients with de novo AML without FISH or cytogenetic changes linked to MDS per WHO 2016 criteria.* Clinical evidence of active central nervous system (CNS) leukemia.* Subjects with active (uncontrolled, metastatic) second malignancies.* Any major surgery or radiation therapy in 4 weeks.* Subjects with myocardial impairment of any cause (eg, cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging).* Uncontrolled infection; subjects with an infection receiving treatment (antibiotic, antifungal, or antiviral treatment) could be entered into the study provided the subject was respiratory and hemodynamically stable for ≥ 72 hours.* Current evidence of invasive fungal infection (blood or tissue culture); subjects with recent fungal infection must have had subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values).* Hypersensitivity to cytarabine, daunorubicin or liposomal products.* Presence of any severe psychiatric disease or physical condition that, according to the physician´s criteria, contraindicates the inclusion of the patient into the clinical trial.* Serum creatinine ≥ 20 mg/dL (unless it is attributable to AML activity).* Bilirubin, alkaline phosphatase, or SGOT > 3 times the ULN (unless it is attributable to AML activity).* Subjects with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent).* History of Wilson's disease or other copper-metabolism disorder.* Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent and until toxicity from this has resolved to grade 1 or less; if the half-life of the agent is unknown, patients must wait 4 weeks prior to first dose of study treatment.
19,088
Study Objectives This study aimed to evaluate the safety and feasibility of SEMS followed by neoadjuvant chemotherapy prior to elective surgery for obstructing left-sided colon cancer. Conditions: Complication of Treatment Intervention / Treatment: COMBINATION_PRODUCT: self-expanding metallic stent placement followed by neoadjuvant chemotherapy
Inclusion Criteria: * histologically proven adenocarcinoma located in the left colon (between the splenic flexure and 15 cm proximal to the anal margin)* Eastern Cooperative Oncology Group (ECOG) performance status of from 0 to 2 Exclusion Criteria: * history of any other cancer* multiple primary colorectal cancers* distant metastases* hereditary nonpolyposis colorectal cancer* familial adenomatous polyposis
2,059
Study Objectives Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree. Conditions: Biliary Tract Cancer Intervention / Treatment: DEVICE: covered biliary stents, DEVICE: uncovered biliary stents
Inclusion Criteria: * adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree * not eligible for surgical intervention * able to provide informed consent Exclusion Criteria: * benign biliary obstruction * previous surgery of the biliary tract * life expectancy < 3 months
8,459
Study Objectives Dr. Frederick Millard, MD, Associate Clinical Professor at the UCSD Cancer Center, will be conducting a 12-week study in advanced prostate cancer patients. The study will be held at the UCSD Medical Center and will test an experimental investigational gene therapy vaccine designed to make the patient's immune system react against telomerase, an enzyme expressed in prostate cancer cells. Conditions: Prostatic Neoplasms Intervention / Treatment: BIOLOGICAL: Transgenic Lymphocyte Immunization Vaccine (TLI)
Inclusion Criteria: * 18 years of age or older, able to understand and sign the informed consent form. * HLA-A2 positive. * Expected survival ≥ 6 months. * Histological evidence of adenocarcinoma of the prostate. * (ECOG) Performance status 0, 1 or 2. The following categories of subjects with androgen-independent prostate cancer are eligible: * Progression of bidimensionally measurable disease assessed within 84 days (12 weeks) prior to enrollment. * Progression of evaluable but not measurable disease (i.e., bone scan) assessed within 112 days (16 weeks) prior to enrollment. * Rising PSA- Rising PSA is defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1). The first rising PSA (measure 2) must be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA is required to be taken and be greater than the second measure. The subject must have a PSA ≥ 5 ng/ml in addition to increasing PSA to be eligible. No minimum PSA is required for subjects with measurable disease or non-PSA evaluable disease. * All subjects must have had a CT scan of the abdomen and pelvis within 84 days (12 weeks) prior to enrollment. * All subjects must also have had a bone scan within 112 days (16 weeks) prior to enrollment. * Subjects must have been surgically or medically castrated. If method of castration is LHRH agonists (leuprolide or goserelin), then the subject should be willing to continue the use of LHRH agonists. Castration using LHRH agonist should not be interrupted and subjects who have stopped treatment should be willing to restart. * If the subject has been treated with non-steroidal anti-androgens (flutamide, bicalutamide, nilutamide or ketoconazole), they must have been stopped at least 28 days prior to enrollment for flutamide or ketoconazole and at least 42 days prior to enrollment for bicalutamide or nilutamide and the subjects must have demonstrated progression. * Subjects may have received prior surgery. However, at least 21 days must have elapsed since completion of surgery and subject must have recovered from all side effects. * All subjects must have pre-study PSA within 28 days of enrollment. Subjects must meet the following initial laboratory criteria: * granulocytes ≥ 1500/ul * platelet count ≥ 100,000/ul * hemoglobin ≥ 10 gms/dl * bilirubin ≤ 1.5 x ULN * AST ≤ 1.5 x ULN * Creatinine ≤ 1.5 x ULN * Testosterone < 50ng/ml for those who have not had bilateral orchiectomy * PSA ≥ 5ng/ml if no measurable disease
20,675
Study Objectives This pilot early phase I trial studies talazoparib to determine if certain characteristics of the deoxyribonucleic acid (DNA) affect how the disease responds to therapy in patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Studying samples of tissue in the laboratory from patients receiving talazoparib may help doctors learn more about the effects of talazoparib on cells and may help doctors understand how well patients respond to treatment. Conditions: Fallopian Tube Serous Adenocarcinoma, High Grade Ovarian Serous Adenocarcinoma, Ovarian Mass, Primary Peritoneal Serous Adenocarcinoma, Stage III Fallopian Tube Cancer AJCC v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIB Ovarian Cancer AJCC v6 and v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IIIC Ovarian Cancer AJCC v6 and v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7 Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, DRUG: BMN 673
Inclusion Criteria: * Patients with presumed advanced-stage high grade serous ovarian, fallopian tube, or primary peritoneal carcinoma, based on the presence of carcinomatosis, and/or elevated cancer antigen 125 (CA125), and/or ovarian mass(es), or at the discretion of the treating physician * Medically able to undergo primary cytoreductive surgery, at least 7 days and up to 28 days after starting study drug, as determined by treating physician * No prior therapy for high-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma * Patients must be able to swallow and tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of BMN 673 (e.g. uncontrolled nausea, vomiting, or diarrhea; malabsorption syndrome; ulcerative disease) * Absolute neutrophil count >= 1,500/mcL (measured within 28 days prior to entry/ randomization) * Hemoglobin >= 9 gm/dL (measured within 28 days prior to entry/ randomization) * Platelets >= 100,000/mcL (measured within 28 days prior to entry/ randomization) * Total bilirubin =< 1.5 X upper limit of normal (ULN) (measured within 28 days prior to entry/ randomization) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal unless the liver is involved with tumor, in that case, ALT/AST must be =< 5 x upper limit of normal (measured within 28 days prior to entry/ randomization) * Creatinine clearance >= 50 mL/min (assessed by Cockcroft Gault estimation) (measured within 28 days prior to entry/ randomization) * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Women of child-bearing potential and their partners must agree to use contraception (hormonal or barrier method of birth control; abstinence) from the time of study entry until 30 days after the last dose of study medication; women of child-bearing potential (intact uterus) should have a negative serum pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; female patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 consecutive months following cessation of all exogenous hormonal treatments * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation; male partners should be instructed to use contraception during the study period * Women must not breast-feed while taking the study medications * Patients must be able to understand and willing to sign an informed consent Exclusion Criteria: * Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer * Receipt of any other investigational agents or any additional anti-cancer agents * Significant symptom burden from presumed diagnosis including large volume ascites, pain requiring narcotic medication, or shortness of breath on exertion * Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication * As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., severe hepatic impairment, interstitial lung disease \[bilateral, diffuse, parenchymal lung disease\], uncontrolled chronic renal diseases \[glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis\]), or current unstable or uncompensated respiratory or cardiac conditions, or uncontrolled hypertension (blood pressure >= 140/90), active bleeding diatheses or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus; screening for chronic conditions is not required * As judged by the investigator, the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
27,403
Study Objectives This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment. Conditions: Prostate Cancer, Prostate Cancer Recurrent Intervention / Treatment: DRUG: F-18-PSMA-1007, DRUG: F-18-Fluorocholine
Inclusion Criteria: * male with original diagnosis of prostate carcinoma with prior definitive therapy * suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy) * life expectancy of 6 months or more as judged by the investigator * willing and able to undergo all study procedures * informed consent in writing (dated and signed) Exclusion Criteria: * age: less than18 years * contraindications for F-18-Fluorocholine * contraindications for any of the ingredients of F-18-PSMA-1007 * close affiliation with the investigational site; e.g. first-degree relative of the investigator * at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial * having been previously enrolled in this clinical trial * mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial * being clinically unstable or requiring emergency treatment * being considered a vulnerable person
38,460
Study Objectives The overall goal of this project is to determine if high dose vitamin D3 given to premenopausal women at high risk for development of breast cancer, who initially have insufficient levels of 25-hydroxy vitamin D (\<30 ng/ml), will raise 25(OH)D levels above 50 ng/ml. If so, will certain risk biomarkers for development of breast cancer be reliably and favorably modulated? Conditions: Breast Cancer Intervention / Treatment: DRUG: vitamin D3
Inclusion Criteria: * Subjects must be premenopausal women age 55 or younger, and actively menstruating with 4 or more periods per year. * Subjects may be using barrier contraceptive, an intrauterine device, a Nuvaring, or similar non-oral contraceptive; or oral contraceptives. * Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria: * five-year Gail risk of 3X the average risk of the age group; * a first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer; * prior biopsy exhibiting atypical hyperplasia (AH), LCIS, DCIS, RPFNA evidence of hyperplasia with atypia within the last three years; * Chest or neck radiation before age 30; * Breast density equals or exceeds 50 percent. * If previously on a chemoprevention agent or prevention trial, subjects must have completed study participation at least 6 months prior to baseline biomarker assessment. * If subject has a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen and is either not eligible or is not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy). * Subject must have had a mammogram performed at the University of Kansas Breast Imaging Center with estimated visual breast density of greater than 10 percent. * Subject must have had within six months prior to entering the study, an RPFNA during the follicular portion (day 1-10) of the menstrual cycle with material for cytomorphology, Ki-67 and qRT-PCR; in addition to serum obtained and banked. * Subjects must have 25(OH)D level < 30 ng/ml as measured within 8 weeks of starting intervention. Subjects may have been identified as having low vitamin D levels through participation in HSC 11313, Osteopenia/Osteoporosis in Pre-menopausal Women at High Risk for Development of Breast Cancer, but low level must be confirmed within 8 weeks prior to starting study agent Subject must be willing to continue the same hormonal milieu present at baseline throughout trial. * Subjects must be willing to undergo measurement of height, weight, and BMI at initiation of intervention. * Subjects must have participated in HSC 11313, and have had a DEXA scan for bone density and body fat analysis on the GE Lunar Prodigy Advance research unit in the Breast Cancer Survivorship Center. * Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA. Exclusion Criteria: * Women that have had a metastatic malignancy of any kind. * Women that have had prior invasive breast cancer If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contra-lateral (uninvolved breast) will be studied by FNA. The subject may not have had any radiation therapy to the contra-lateral breast to be studied. * Women who are pregnant or nursing. * Women who have taken a SERM, aromatase inhibitor or participated in a chemoprevention or other investigational drug study within six months prior to baseline FNA. * Women who have used fertility drugs within six months prior to baseline aspiration. * Women with a history of sarcoidosis, hypercalcemia, hyperparathyroidism, or renal stones. * Women who are receiving treatment for rheumatoid arthritis or other connective tissue diseases. * Women who have an elevated blood calcium level at baseline; defined as any elevation above the institutional normal range.
15,353
Study Objectives The primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard therapy. Conditions: Relapsed/Refractory Multiple Myeloma Intervention / Treatment: DRUG: ABT-199, DRUG: bortezomib, DRUG: dexamethasone
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1 * Diagnosis of multiple myeloma previously treated with at least 1 prior line of therapy (dose escalation only) or (safety expansion only) received treatment with a proteasome inhibitor or an IMiD(r) or immunomodulatory agent (e.g., thalidomide, lenalidomide). Induction therapy and following stem cell transplant are considered a single line of therapy. * Measurable disease at Screening: Serum monoclonal protein greater than or equal to 1 g/dL by protein electrophoresis, or greater than or equal to 200 mg monoclonal protein in the urine on 24-hr electrophoresis, or serum immunoglobulin free light chain greater than or equal to 10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio. * Subjects with a history of autologous or allogenic stem cell transplant must have adequate bone marrow independent of any growth factor support, and have recovered from any transplant related toxicity(s); and either greater than 100 days post-autologous transplant (prior to first dose of study drug) or greater than or equal to 6 months post-allogenic transplant (prior to first dose of study drug) and not have active graft-versus-host disease (i.e., requiring treatment). * Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening. Exclusion Criteria: * Exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal), diagnosis of fever and neutropenia within 1 week prior to first dose of study drug * Cardiovascular disability status of New York Heart Association Class greater than or equal to 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or anginal pain. * Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease, that in the opinion of the investigator, would adversely affect his/her participation in the study. * History of other active malignancies other than multiple myeloma within the past 3 years prior to study entry, with the following exceptions: adequately treated in situ carcinoma of the cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. * Tested positive for HIV or hepatitis.
36,680
Study Objectives Phase II trial to study the effectiveness of combining rituximab and rasburicase with combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug with rituximab may kill more cancer cells. Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of chemotherapy. Conditions: Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Small Noncleaved Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Small Noncleaved Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Small Noncleaved Cell Lymphoma, Untreated Childhood Acute Lymphoblastic Leukemia Intervention / Treatment: DRUG: doxorubicin hydrochloride, DRUG: cyclophosphamide, DRUG: methotrexate, DRUG: rasburicase, DRUG: leucovorin calcium, DRUG: prednisone, DRUG: methylprednisolone, BIOLOGICAL: filgrastim, BIOLOGICAL: rituximab, DRUG: cytarabine, DRUG: etoposide, DRUG: vincristine sulfate, DRUG: hydrocortisone sodium succinate, OTHER: laboratory biomarker analysis
Inclusion Criteria: * Newly diagnosed mature B-lineage (CD20-positive) leukemia or lymphoma by the REAL classification of 1 of the following subtypes: * Diffuse large cell lymphoma * Burkitt's lymphoma * High-grade B-cell lymphoma (Burkitt-like) * No B-cell anaplastic large cell Ki-1 positive lymphomas and B-lymphoblastic lymphomas * One of the following FAB prognostic groups: * Group B (intermediate risk) * Group C (high risk) * Bone marrow involvement with at least 25% blasts and/or CNS involvement meeting 1 or more of the following criteria: * Any L3 blasts in cerebrospinal fluid * Cranial nerve palsy (if not explained by extracranial tumor) * Clinical spinal cord compression * Isolated intracerebral mass * Parameningeal extension (cranial and/or spinal) * Hepatitis B status known * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * No known history of congenital immune deficiency and/or laboratory evidence of acquired immune deficiency * No known G6PD deficiency (if receiving rasburicase) * No prior malignancies treated with systemic chemotherapy with alkylator or anthracycline therapy * No prior chemotherapy * At least 1 week since prior steroids except emergency steroids initiated within 72 hours of study entry * No prior radiotherapy except emergency radiotherapy initiated within 72 hours of study entry * No concurrent radiotherapy * No prior solid organ transplantation
34,932
Study Objectives This is a multicenter retrospective study that collected diagnostic information of patients with pleural effusion. The overall survival (OS) time of malignant patients was followed up, defined as the time from diagnosis to death. Clinical data and residual pleural effusion specimens were collected from patients. Metabonomics was utilized to differentiate between benign and malignant pleural effusion and to evaluate the prognosis of lung cancer patients with malignant pleural effusion. Conditions: Pleural Diseases Intervention / Treatment: OTHER: Detection of pleural effusion
Inclusion Criteria: * 18 Years to 80 Years; detection of pleural effusion by chest computed tomography, radiography, or ultrasonography; pathologically confirmed lung cancer in pleural effusion. Exclusion Criteria: * pleural effusion not caused by lung cancer or of unknown origin; other concurrent malignant diseases; incomplete information; lack of any follow-up data.
4,842
Study Objectives In this Phase I/II clinical trial, the investigators seek to pilot the addition of Hydroxychloroquine (HCQ) to a commonly-used front-line therapy of pancreatic cancer, gemcitabine/nab-paclitaxel. The investigators plan a run-in to define tolerable doses, and will explore doses of 800 and 1200 mg/day in successive cohorts of 6 patients. The investigators will assess toxicity continuously, and determine the dose for the Phase II trial based on standard toxicity criteria. The correlative endpoints of this trial are directed to the pharmacokinetics of HCQ, and pharmacokinetic model of HCQ based on data from several ongoing trials, and the data from these patients will contribute to refining the model. The investigators will analyze both measured and model-predicted indices for their relationship to autophagy induction. Autophagy will be assessed as the accumulation of autophagocytic vesicles in the PMNs of treated patients, together with the induction of the expression of autophagy-related proteins on western analysis, quantitated by densitometry. The investigators will document the rates of metabolic response as a consequence of treatment, as a therapeutic marker that may be related to the degree of autophagy inhibition. Since the investigators have previously demonstrated a key role of JNK1 in the induction of autophagy by chemotherapy, the investigators will analyze archival tumor materials to determine variability in this marker, as a baseline for potential future trials. Finally, this study will incorporate metabolic profiling by mass spectrometry, which will be related to mutations (including Kras) in pretreatment tumor specimens. Mutational analysis will be accomplished by targeted sequencing or by next-generation sequencing, and the need for fresh tissue for all these endpoints will require patients to have a biopsy performed before treatment at at 6-8 weeks after beginning treatment. In the previous study of the Hh inhibitor GDC-0973 with the same chemotherapy, the investigators were able to obtain repeat biopsies successfully on all patients. The importance of these biopsies, to move the science forward in an era in which the tools now exist to provide meaningful correlative science, cannot be overstated. Conditions: Advanced Adenocarcinoma, Metastatic Adenocarcinoma Intervention / Treatment: DRUG: Hydroxychloroquine (HCQ), DRUG: Gemcitabine, DRUG: Abraxane
Inclusion Criteria: * Patients must have histologically or cytologically documented advanced or metastatic adenocarcinoma of the pancreas. * Patients must have measurable disease as defined by the RECIST criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm with conventional techniques on either CT or MRI. Marker (CA19-9 or CEA) elevation alone is insufficient for entry. * Patients may have had prior adjuvant treatment for pancreatic cancer. The last dose of chemotherapy must have been 4 months prior to study entry. * Patients with prior radiotherapy are acceptable. It must be at least 4 months since administration of radiation therapy and all signs of toxicity must have abated. * Patients must be age 18 years or older. * Patients must have an ECOG performance status of 0-1. * The following required Initial Laboratory Values should be obtained within 4 weeks of the start of treatment: * Granulocytes 1,500/ml * Platelet Count 100,000/ml * Creatinine 1.5 x upper limit of normal * Bilirubin 1.5 x upper limit of normal * AST 5 x upper limit of normal * Patients must not be pregnant or lactating as chemotherapy is thought to present substantial risk to the fetus/infant. * Patients must have an accessible primary tumor or metastasis, and be willing to have a pre-treatment and post-treatment tumor biopsy (at 6 to 8 weeks after beginning). * Patients must have a life expectancy of greater than three months. * Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients may not be receiving any other investigational agents * Known allergy to HCQ * Patients with previous treatment with abraxane. * Patients on therapeutic doses of Coumadin ( 1 mg daily). The use of therapeutic or prophylactic low molecular weight heparin or fragmin is permitted. * Patients with known G6PD deficiency, severe psoriasis, porphyria, macular degeneration or severe diabetic retinopathy are ineligible because of the potential for greater HCQ toxicity.
17,056
Study Objectives This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors. Conditions: Advanced Cancer Intervention / Treatment: BIOLOGICAL: CS1003, BIOLOGICAL: CS1003, DRUG: Regorafenib
Inclusion Criteria: * Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.* ECOG performance status of 0 or 1.* Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.* Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.* Life expectancy ≥ 3 months.* Subject must have adequate organ function.* Use of effective contraception (males and females). Exclusion Criteria: * Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.* Subjects with active autoimmune diseases or history of autoimmune diseases.* Subjects who have to receive glucocorticoids (prednisone at > 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS1003.* Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib, except for those with basal cell carcinoma, in situ breast cancer and cervical carcinoma in situ who have undergone radical treatment.* Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.* Receipt of chemotherapy, targeted therapy, or any other anti-cancer systemic treatment within 2 weeks prior to the first dose of CS1003.* Receipt of major surgical procedure or wide field of radiation within 28 days prior to the first dose of CS1003, local radiotherapy within 14 days prior to the first dose of CS1003, or radioactive agents within 56 days before the first dose of CS1003.* Receipt of Chinese herbal medicine or Chinese prepared medicine within 7 days prior to the first dose of CS1003.* Receipt of live vaccine within 28 days prior to the first dose of CS1003.* History of interstitial lung disease or non-infectious pneumonitis, except for those induced by radiation therapies.* History of HIV infection.* Subjects with active Hepatitis B and C infection (HBV DNA ≥ 1000 cps/mL or 200 IU/mL) requiring therapy.* Subjects with active infection of tuberculosis.* Subjects with signs or symptoms of any active infection requiring systemic therapy.* History of organ transplantation.* Unresolved toxicities from prior anti-cancer therapy.* History of any irAE of Grade ≥ 3.* History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.* History of alcoholism or drugs abuse.* Subjects with major cardiovascular diseases.* Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance. For more information regarding trial participation, please contact at [email protected]
37,800
Study Objectives Preclinical models of urogenital carcinoma have been emerging as a way to pre-determine drug resistance before therapy is targeted. The implantation of tumor specimens in the chorioallantoic membrane (CAM) of the chicken embryo results in a high-efficiency graft, thus allowing large-scale studies of "tumor avatar". The aim of the study is to develop a tumor culture platform for treatment evaluation. Biopsies will be collected from primary tumors of patients and grafted onto the chorioallantoic membrane of chicken embryos. After tumor implantation at the CAM, tumor growth will be accompanied by imaging that will quantify tumor vascularization, tumor volume, and tumor blood flow. Following tumor growth, "avatars" will be divided into different treatments. Using the "tumor avatar" model together with patient tumors, the investigators will be able to observe the individualized tumor response for each patient in a treatment context, as well as determine the potential drug to be used in each case. These results may support a phenotype-based reading within 7-10 days. Conditions: Urogenital Neoplasms, Drug Therapy Intervention / Treatment: DIAGNOSTIC_TEST: Biopsy
Inclusion Criteria: * Urogenital neoplasm * Undergo biopsy Exclusion Criteria: * Not accept to participate
15,140
Study Objectives The aim of this study is to evaluate if acupuncture prevents or reduces nausea or vomiting during radiotherapy Conditions: Nausea, Vomiting Intervention / Treatment: PROCEDURE: Acupuncture, PROCEDURE: Sham
Inclusion Criteria: * patients of at least 18 years of age * with gynaecologic-, anal-, rectal-, colon-, ventricle-, pancreatic- or testicular tumours * willing to give their informed consent * able to take part in the entire treatment and data collection procedure * had planned radiation over an abdominal and/or pelvic field (with or without concomitant chemotherapy) with the volume of at least 800 cm3 and a dose of at least 25 Gy. Exclusion Criteria: * use of antiemetic treatment or persistent nausea within 24 hours prior to the start of radiotherapy * ever received acupuncture against nausea, or during the last year received acupuncture for any indication.
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Study Objectives In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line treatment of elderly and/or poor performance status patients with extensive stage small cell lung cancer. Patients eligible for this trial will be those considered poor candidates for standard combination chemotherapy or other investigational regimens Conditions: Lung Cancer Intervention / Treatment: DRUG: Topotecan
Inclusion Criteria: To be included in this study, you must meet the following criteria: * Biopsy-proven small cell lung cancer, extensive stage disease * Age > 65 years * No previous chemotherapy or radiation therapy. * Measurable or evaluable disease. * Adequate bone marrow, liver and kidney function. * Must be > 4 weeks from previous major surgery * Must give written informed consent prior to study entry. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: * Meningeal involvement * Serious active infections * Serious underlying medical conditions * Other active neoplasms Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
5,135
Study Objectives This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was conducted in 17 countries, started in 2010 and ended in 2018. Conditions: Myelodysplastic Syndromes Intervention / Treatment: DRUG: Deferasirox, DRUG: Placebo
Inclusion Criteria: * Weigh between 35-135 kilograms * Low or int-1 risk MDS * Ferritin >1000 micrograms/liter at screening * History of transfusion of 15 to 75 Packed Red Blood Cells (PRBC) units * Anticipated to be transfused with at least 8 units of PRBCs annually during the study * Women of child-bearing potential using effective methods of contraception during dosing of study treatment Exclusion Criteria: * More than 6 months of cumulative ICT (such as daily deferasirox (Exjade®) or deferiprone or 5×/week deferoxamine) * More than 3 years since patient began receiving regular transfusions (2 units per 8 weeks or 4 units received in a 3 month period) * Significant proteinuria * History of hospitalization for congestive heart failure; other heart conditions as specified in the protocol * Systemic diseases which would prevent study treatment * Hepatitis B; Hepatitis C; HIV * Liver cirrhosis * Pregnant, or breast-feeding patients, or patients of child-bearing potential not employing an effective method of birth control * History of drug or alcohol abuse within the 12 months prior to enrollment
7,768
Study Objectives This study aims to test the use of novel CT image analysis techniques to enable a better characterisation of small pulmonary nodules. The study will incorporate solid and predominantly solid nodules of 5-15 mm scanned using a variety of scanner types, imaging protocols and patient populations. The investigators hope that the new image processing techniques will improve the accuracy of lung nodule analysis which will in turn reduce the number of unnecessary investigations for benign nodules and may increase the accuracy of the early diagnosis of lung cancer in malignant nodules. This study aims to test this novel analysis software to subsequently allow validation. Conditions: Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple, Lung Cancer Intervention / Treatment:
Inclusion Criteria: * Male or Female, aged 18 years or above * CT scans identified as having pulmonary nodule(s) of 5-15mm * Patients with solid or predominantly solid nodules referred to the pulmonary nodule clinic or for CT scan review by a specialist * CT scan section thickness of 3mm and less Exclusion Criteria: * The CT scans are technically inadequate * Having received treatment for cancer in the last 5 years * Patient has more than five reported qualifying nodules
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Study Objectives The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies. Conditions: Lymphoma, B-Cell, T-Cell Lymphoma Intervention / Treatment: DRUG: RP6530
Inclusion Criteria: * Refractory to or relapsed after at least 1 prior treatment line. * ECOG performance status ≤2 * Patients must be ≥18 years of age * Able to give a written informed consent. Exclusion Criteria: * Any cancer therapy in the last 4 weeks or limited palliative radiation <2 weeks * Patients with HBV, HCV or HIV infection * Autologous hematologic stem cell transplant within 3 months of study entry. Allogeneic hematologic stem cell transplant within 12 months. * Previous therapy with GS-1101 (CAL-101, idelalisib), IPI-145, TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib). * Patients on immunosuppressive therapy including systemic corticosteroids. * Patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.). * Patients with known history of liver disorders. * Patients with uncontrolled Diabetes Type I or Type II * Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. * Women who are pregnant or lactating.
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Study Objectives Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. The investigators have previously reported that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in samples with low cell counts. In the framework of the national Campus ALL program aimed at improving the management of adult ALL patients in the context of the GIMEMA protocols, in the present study the investigators retrospectively evaluated the incidence of occult CNS positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13 centers. Conditions: Acute Lymphoblastic Leukemia Intervention / Treatment: DIAGNOSTIC_TEST: evaluation of cerebrospinal fluid of ALL
Inclusion Criteria: * ALL at onset * Age >18 years Exclusion Criteria: * ALL relapsed or refractory * Age <18 years
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Study Objectives A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism. Conditions: Multiple Myeloma, Non-Hodgkin-Lymphoma, Hodgkin's Disease Intervention / Treatment: DRUG: Cyclophosphamide
Inclusion Criteria: * Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkin's disease after allogeneic stem cell transplantation with reduced intensity conditioning * Written informed consent * No uncontrolled infections Exclusion Criteria: * Severe organ dysfunction defined as: * Cardiac left ventricular ejection fraction (LVEF) of less than 35% * diffusing lung capacity (DLCO) of less than 40% * total lung capacity (TLC) of less than 40% * forced expiratory volume (FEV1) of less than 40% * total bilirubin >3mg/dl * creatinine-clearance of less than 40 ml/min * pregnancy or breast feeding * participation in other experimental drug trials
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Study Objectives This study evaluates addition of Vincristine Sulfate Liposome Injection (Marqibo®) to the standard regimen of Bendamustine and Rituximab in adult patients with indolent B-cell lymphoma. This is a dose-escalation study. Conditions: Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Small-Cell, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone Intervention / Treatment: DRUG: Rituximab, DRUG: Bendamustine, DRUG: Vincristine sulfate liposome injection
Inclusion Criteria: * Histologically confirmed indolent B-cell non-Hodgkin lymphoma. * Radiological measurable disease. * Previous treatment for lymphoma is allowed, with the exception of use of bendamustine within 6 months or any prior use of vincristine sulfate liposome injection * Eastern Cooperative Oncology Group performance status 0 or 1; * Life expectancy of at least 6 months; * Adequate organ and marrow function; * Women of child-bearing potential and men must agree to use adequate contraception. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of allergic reactions attributed to any drug used in the study. * Any lymphoma-directed therapy within 4 weeks. * Any prior treatment with vincristine sulfate liposome injection. * Prior treatment with bendamustine or vincristine sulfate within 180 days of enrollment. * Patients who are receiving any other investigational agents with the exception of endocrine therapy for breast or prostate cancer. * Central nervous system involvement. * Peripheral sensory or motor neuropathy. * History of a demyelinating condition. * Positive test for the Human Anti-Chimeric Antibody (HACA). * Patients receiving any medications or substances that are strong inhibitors or inducers of Cytochrome P450, family 3, subfamily A (CYP3A) enzyme are ineligible. * Uncontrolled intercurrent illness. * Prisoners. * Pregnant or breast-feeding women. * Known Human Immunodeficiency Virus (HIV) or active Hepatitis B infection * Any prior or active cancer, which in the opinion of the investigator would preclude safe participation in this study.
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Study Objectives Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets for pancreaticobiliary cancer patients. The investigators expect that customized diets for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes. Conditions: Ketogen-based Therapeutic Diet, Pancreaticobiliary Cancer Intervention / Treatment: DIETARY_SUPPLEMENT: Ordinary Diet, DIETARY_SUPPLEMENT: Modified Atkin's Diet, DIETARY_SUPPLEMENT: Ketogenic Diet
Inclusion Criteria: * Adult (age more than 19) * Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy * Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer Exclusion Criteria: * Patient who denied clinical trial * Diabetes Mellitus(DM) patient with DM complication * Hyperlipidemia patient with vascular co-morbidity * Impaired renal function or renal failure (GFP<90%)
28,046
Study Objectives Objectives: Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLT) of combining lapatinib and temozolomideSecondary - Obtain preliminary information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain metastases secondary to HER-2 positive breast cancer including Objective Response Rate (ORR), Clinical Benefit (CB) and Duration of Response (DR) Methodology: Phase I, single-centre, open-label, dose-escalation study of combining lapatinib and temozolomide in HER-2 positive breast cancer patients with progressive brain metastases after surgery or radiotherapy or radiosurgery Treatment: Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day.Sequential cohorts will be escalated in increments according to the dose escalation scheme, and determined by dose limiting toxicities. Conditions: Metastatic Breast Cancer, Brain Metastases, HER2 Positive Intervention / Treatment: DRUG: lapatinib and temozolomide
Inclusion Criteria: * 18 - 70 years * Women with cytologically or histologically proven metastatic breast cancer with recurrent / progressive brain metastases evaluable by MRI, after standard treatment with surgery (at least 3 weeks prior) or WBRT (at least 3 weeks prior) or stereotactic RT (at least 1 week prior); or otherwise deemed as unsuitable for standard treatment in the first instance * Known HER-2 positive status (immunohistochemistry (IHC) 3+ Fluorescence In Situ Hybridization (FISH) positive ) * Previous chemotherapy (adjuvant and metastatic regimens) allowed * Previous treatment with trastuzumab allowed (Trastuzumab to be discontinued prior to study entry) * At least one measurable lesion in the brain, defined as any lesion >5mm in longest dimension on T1-weighted, gadolinium-enhanced MRI * Expected life-expectancy of more than 3 months * ECOG performance status of 0, 1 or 2 * Adequate bone marrow, renal and hepatic functionsLVEF * LVEF >50% measured by echocardiography or MUGA scan * Concomitant corticosteroids and anti-convulsants for symptomatic brain metastases are allowed
29,604
Study Objectives FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in participants with advanced solid tumors. Conditions: Advanced Solid Tumors, Lymphoma, Gastric Cancer, Colorectal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, EGFR Positive Solid Tumor, HER2-positive Breast Cancer, Hepatocellular Carcinoma, Small Cell Lung Cancer, Renal Cell Carcinoma, Pancreas Cancer, Melanoma, NSCLC, Urothelial Carcinoma, Cervical Cancer, Microsatellite Instability, Merkel Cell Carcinoma Intervention / Treatment: DRUG: FT500, DRUG: Nivolumab, DRUG: Pembrolizumab, DRUG: Atezolizumab, DRUG: Cyclophosphamide, DRUG: Fludarabine, DRUG: IL-2
Inclusion Criteria: * Diagnosis of the following, as per Regimen Cohort: 1A. Regimen A: FT500 Monotherapy (Dose Escalation): An advanced solid tumor malignancy, including lymphoma, in a participant who has failed or refused available FDA-approved therapies and is now a candidate for salvage therapy. 1B. Regimen B and BB (Dose Escalation): FT500 (+ IL-2, Regimen BB only) + ICI: An advanced solid tumor malignancy, including lymphomas, that has progressed on treatment with at least one ICI (ie, nivolumab, pembrolizumab or atezolizumab), in a participant who has also failed or refused other available approved therapies and is now a candidate for salvage therapy. 1C. Regimen B(Dose Expansion): FT500 (+ IL-2, Regimen BB only) + ICI An advanced solid tumor malignancy or lymphoma in a participant with disease relapse or progression on an ICI (nivolumab, pembrolizumab, or atezolizumab) in an approved indication per the respective USPI. * Willingness to provide informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Age >18 years old at the time of signing the ICF. 4. Presence of measurable disease by iRECIST or RECIL criteria, assessed before the start of lympho-conditioning and within 28 days prior to Day 1. * Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 5a. Female participants: Women of childbearing potential (WOCBP) must use a highly effective form of contraception from the screening visit until at least 12 months after the final dose of CY, at least 4 months after the final dose of FT500, at least 4 months after the final dose of pembrolizumab, and at least 5 months after the final dose of nivolumab or atezolizumab, whichever is latest. 5b. Male participants: Males must be sterile (biologically or surgically) or use a highly effective method of contraception from the screening visit until at least 14 months after the final dose of CY, at least 6 months after the final dose of FT500, at least 6 months after the final dose of pembrolizumab, and at least 7 months after the final dose of nivolumab or atezolizumab, whichever is latest. * Willingness to comply with study procedures through the planned study duration. For patients with >1 measurable lesion, agreement to undergo a biopsy from a safely accessible site per Investigator assessment for exploratory biomarker assessments. * Provision of signed and dated ICF to agree to participate, at time of withdrawal or completion of this study, in Fate Therapeutics' long-term, non-interventional, observational study, FT-003. Exclusion Criteria: All participants: * Females who are pregnant or breastfeeding. 2. ECOG performance status ≥ 2. 3. Evidence of insufficient organ function as determined by any one of the following: 3a. Neutrophils <1000/µL or platelets <75,000/µL. 3b. Estimated creatinine clearance <50 mL/minute (Cockcroft-gault). 3c. Total bilirubin >2 x upper limit normal (ULN) with the exception of participants with Gilbert's Syndrome or known liver metastases. 3d. Aspartate aminotransferase (AST) >3 x ULN, or alanine aminotransferase (ALT) >3 x ULN. For participants with known liver metastases, AST or ALT >5 x ULN. 3e. Oxygen saturation <90% on room air. 3f. Left ventricular ejection fraction (LVEF) <40% (eg by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan). *Receipt of any biological therapy, chemotherapy, or radiation (except palliative radiation) within 2 weeks prior to Day 1. Participants in Regimen B currently taking an ICI must interrupt ICI dosing at least 2 weeks prior to Day 1. * CNS metastases that have not been treated; or treated CNS metastases that have not been stable for at least 4 weeks. * Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first study medication; or the presence of unstable angina or congestive heart failure of New York Heart Association grade 2 or higher. * Currently receiving or likely to require systemic immunosuppressive therapy (eg, prednisone >5 mg daily) for any reason from Day -7 to Day 29. * Uncontrolled infections. 9. Known allergy to the following FT500 components: Albumin (Human) or DMSO. 10. Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to participant. * Any medical condition or clinical laboratory abnormality that, per Investigator or Medical Monitor judgement, precludes safe participation in and completion of the study, or that could affect compliance with protocol conduct or interpretation of results. Participants who have had prior receipt of a Fate Therapeutics investigational human iPSC product may be eligible for the study with approval from the Medical Monitor. Additional Exclusion Criteria for Regimen B: FT500 + ICI: * Participants who experienced an ICI-related adverse reaction that resulted in discontinuation of the ICI. * Presence or history of autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma, Crohn's disease, ulcerative colitis), except for participants with isolated vitiligo, atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and controlled thyroid disease. * Participants who have received an allograft organ transplant.
12,945
Study Objectives Allogeneic bone marrow transplantation (BMT) is a curative treatment for patients with chronic myelogenous leukemia (CML) and other lymphoid/hematologic malignancies but is available as a treatment option to only a minority of patients. Autologous BMT, coupled with high dose chemotherapy, is a treatment open to more patients and is a promising strategy for the treatment of advanced solid malignancies. However, the development of potentially curative marrow transplant alternatives requires an ability to provide a nonmalignant hematopoietic stem cell population. In addition, the generation of hematopoietic stem cells (HSC), and the determination of whether or not such HSC repopulate all of the cell lineage subtypes following reinfusion are critical to understanding the biology and immunological consequences of stem cell transplantation. An increased understanding of the kinetics of HSC and lymphocyte repopulation post-BMT and the identification of donor cell populations that mediate a graft versus leukemia (GVL) effect or graft versus host (GVHD) is critical to therapeutic efficacy. In order to address these currently unmet objectives, normal volunteers and volunteers with malignancies will undergo venipuncture and bone marrow aspiration with or without prior \[6,6-(2)H(2)\] or \[U-(13)C(9)\]-glucose, infusion to provide cell populations which will then be utilized for specific pre-clinical studies aimed at developing new therapeutic alternatives for patients with CML and other lymphoid/hematologic malignancies. An infusion of \[6,6-(2)H(2)\] or \[U-(13)C(9)\]-glucose prior to bone marrow and/or leukocyte harvest, in some volunteers, will allow direct examination of the genesis and biology of stem cells and leukocyte subpopulations. \[6,6-(2)H(2)\] or \[U-(13)C(9)\]-glucose, are nonradioactive, stable isotopes of glucose which will label dividing cells during the time of administration and is chemically identical to glucose, with no adverse side effects other than those known for glucose. Conditions: Chronic Myeloid Leukemia, Healthy, Hematologic Neoplasm, Lymphoma Intervention / Treatment:
INCLUSION CRITERIA: All volunteers at the Clinical Center will be recruited through and registered with the NIH Volunteer Office. Volunteers at collaborating institutions will be recruited through Associate Investigators at that institution according to institutionally IRB approved methods. All volunteers may be normal volunteers or have a diagnosis of a lymphoid/hematologic malignancy (chronic myelogenous leukemia, multiple myeloma, lymphoma, acute myelogenous leukemia, chronic lymphocytic leukemia, acute lymphocytic leukemia). To be eligible peripheral blood apheresis, all normal volunteers must have a hematocrit of greater than or equal to 36% and a peripheral platelet count of greater than or equal to 100,000/mm(3). Volunteers with a lymphoid/hematologic malignancy must have a hematocrit of greater than or equal to 30% and a peripheral platelet count of greater than or equal to 100,000/mm(3). All volunteers, including those volunteers with lymphoid/hematologic malignancies, must have a white blood cell count of greater than or equal to 4,000/mm(3). Volunteers with a lymphoid/hematologic malignancy must have a white blood cell count of less than 100,000/mm(3). To be eligible for venipuncture or bone marrow aspiration, normal volunteers and volunteers with lymphoid/hematologic malignancies must have no history of an abnormal bleeding tendency or documented predisposition to infection. For venipuncture and bone marrow aspiration, the peripheral blood platelet count of normal volunteers must be greater than 100,000/mm(3) and for volunteers with a lymphoid/hematologic malignancy, the platelet count must be greater than or equal to 50,000/mm(3). All normal volunteers and volunteers with a lymphoid/hematologic malignancy are eligible to receive apheresis (done only at the NIH Clinical Center), bone marrow sampling, or venipuncture. Apheresis will only be performed at the Clinical Center of the National Institutes of Health. Apheresis will not be peformed at collaborating institutions. Normal volunteers and volunteers with lymphoid/hematopoietic malignancies may donate samples by apheresis, venipuncture, and bone marrow sampling on multiple occasions. Repeated donation by apheresis will be allowed as long as a period of at least eight week has elapsed since a previous apheresis. Repeated donations of peripheral blood or bone marrow will be allowed as long as a period of at least four weeks has elapsed since a previous donation. For any given volunteer, the total number of aphereses will not exceed six per year and the total number of peripheral blood or bone marrow donations will not exceed eight per year. All normal and CML volunteers must undergo repeat physical examination and complete blood count evaluation to determine eligibility prior to donation. Normal volunteers and volunteers with lymphoid/hematologic malignancies will not be tested for HIV or hepatitis to determine eligibility for this protocol. However, DTM guidelines will require that patients undergoing apheresis with subsequent ex vivo elutriation of the collected products will be required to have testing for HIV and hepatitis B and C. Volunteers who are required to be tested for HIV and Hepatitis will be informed at the time of enrollment and will sign an appropriate informed consent for these tests. Volunteers who are found to be HIV positive or hepatitis B or C can still donate blood products, but these products will not be subjected to ex vivo elutriation. Volunteers with lymphoid/hematologic malignancies may be receiving therapy such as chemotherapy or chronic interferon alpha injections. EXCLUSION CRITERIA: Any normal volunteer or volunteer with a lymphoid/hematologic malignancy with significant history of cardiac, renal, pulmonary, or neurologic disease will be ineligible. Any normal volunteer or volunteer with a lymphoid/hematologic malignancy with a known history of HIV or hepatitis B or C will be ineligible. Any normal volunteer or volunteer with a lymphoid/hematologic malignancy requiring chronic anticoagulation or steroid therapy will be ineligible. Any volunteer with a lymphoid/hematologic malignancy with a peripheral blast count that exceeds 25% or a total lymphocyte count that exceeds 100,000/mm(3) will be ineligible for apheresis. Volunteers with a lymphoid/hematologic malignancy who are currently enrolled in an experimental therapy on an NCI protocol will be ineligible. Any normal volunteer or volunteer with a lymphoid/Hematologic malignancy with known AIDS and/or hepatitis B or C will be excluded. Volunteers with a history of diabetes mellitus will be excluded from receiving \[6,6-(2)H\] or \[U-(13)C9\]-glucose infusions. A pregnancy test will be given to all female volunteers and volunteers who are pregnant will be excluded from the study.
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Study Objectives This phase I trial studies the side effects and best dose of everolimus when given together with anakinra or denosumab in treating participants with cancers that have spread to other places in the body and have come back or aren't responding to treatment. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anakinra is designated to block a protein that is involved in tumor development, new blood vessels growing, and the spread of cancer. Monoclonal antibodies, such as denosumab, may interfere with the ability of tumor cells to grow and spread. Giving everolimus and anakinra or denosumab may work better in treating participants with advanced cancers. Conditions: Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm, Refractory Malignant Neoplasm Intervention / Treatment: BIOLOGICAL: Anakinra, BIOLOGICAL: Denosumab, DRUG: Everolimus
Inclusion Criteria: * Patients with advanced or metastatic cancers that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months. * Patients must be >= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment provided that radiation is not delivered to the only site of disease being treated under this protocol. For biologic/targeted agents patients must be >= 5 half-lives or >= 3 weeks form the last dose (whichever comes first). * Eastern Cooperative Oncology Group (ECOG) performance status =< 2. * Absolute neutrophil count (ANC) >= 1,000/mL. * Platelets >= 75,000/mL. * Creatinine clearance >= 35 ml/min. * Total bilirubin =< 2 X upper limit of normal (ULN) (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome). Exception for patients with liver metastasis: total bilirubin =< 3 x ULN. * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) and or aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =< 5 X ULN. Exception for patients with liver metastasis: ALT (SGPT) =< 8 X ULN. * Fasting lipid profile: cholesterol =< 350 mg/dL. * Fasting lipid profile: triglycerides =< 400 mg/dL. * Corrected calcium >= 8.4 mg/dL. * Phosphorus >= 2.5 mg/dL for denosumab. * Oral examination and appropriate preventive dentistry will be performed prior to the initiation of denosumab therapy. * Negative tuberculosis quantiferon test for anakinra arm. * Negative serology for histoplasma, blastomycosis, and Coccidioidomycosis for anakinra arm. * Negative serology for active hepatitis B and C for anakinra arm. Patients with positive serology for hepatitis B might eligible if they are willing to take lamivudine preventive therapy. * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose. * Patients must be able to understand and be willing to sign a written informed consent document. Exclusion Criteria: * Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support. Treatment of pre-existing invasive fungal infections must be completed prior to starting treatment. * Patients with an active infection. * Pregnant or lactating women. * History of hypersensitivity to anakinra. * History of hypersensitivity to denosumab. * History of hypersensitivity to everolimus. * History of hypersensitivity to any component of the formulation. * Patients unwilling or unable to sign informed consent document. * Patients treated with TNF antagonists. * Patients with a history of active systemic fungal infection. * Patients with liver disease Child Pugh classification B and C.
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Study Objectives The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer Conditions: Breast Cancer Intervention / Treatment: DRUG: PD 0332991, DRUG: letrozole, DRUG: letrozole
Inclusion Criteria: * Inoperable estrogen receptor positive and HER2 negative breast cancer. * Postmenopausal status. * Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory. * Acceptable bone marrow, liver and kidney function. Exclusion Criteria: * Prior or concomitant treatment for advanced breast cancer. * Other major cancer in the past 3 years. * Important cardiovascular events in the past 6 months.
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Study Objectives The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Conditions: Non-Small Cell Lung Cancer Stage IV Intervention / Treatment: DRUG: Abemaciclib, DRUG: Docetaxel
Inclusion Criteria: * Confirmed diagnosis of stage IV NSCLC. * Have progressed during or after platinum-based chemotherapy for advanced disease. * Have not received prior treatment with docetaxel. * Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived material. * Have adequate organ function including hematology, renal, and liver. * Have good performance score (0-1). * Have measurable disease per RECIST 1.1. * Agree to use a reliable medically approved method of birth control. Exclusion Criteria: * Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment administered is not known. * Are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device. * Have the presence of unstable central nervous system (CNS) metastasis. * Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.
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Study Objectives Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their growth is usually slow and diagnosis is often made in the context of masse effect .The therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an individualized follow-up and recurrence could happen 10 or 15 years after the first surgery. In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to find predictive factors of recurrence to personalized the follow-up of each patient. Conditions: Pituitary Adenomas Intervention / Treatment: OTHER: Patients
Inclusion Criteria: * Patients >18 year-old * diagnosis of NFPAs confirmed with hormonal and histological analysis * patients who underwent surgery in neurosurgery unit of the Reims university hospital between 01/01/1991 and 31/12/2004 Exclusion Criteria: *
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Study Objectives Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus. Conditions: Leiomyoma, Laparoscopy, Uterine Myomectomy Intervention / Treatment: DRUG: Standard, DRUG: Standard-vaginal misoprostol
Inclusion Criteria: * Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted laparoscopic myomectomy. Exclusion Criteria: * History of adverse reaction or allergy to Vasopressin.* History of adverse reaction or allergy to Misoprostol.* Medical contraindication to use of Vasopressin or Misoprostol* Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue.* Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating.* Any clinically significant even or condition uncovered during the surgery, such as excessive bleeding or decompensation, that might render the subject medically unstable to continue the study or complicate the subject's intraoperative or postoperative course.* Pregnant women
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