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Study Objectives
The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (PSA) levels.
Conditions: Locally Advanced Prostate Cancer
Intervention / Treatment:
DRUG: Iressa
| Inclusion Criteria:
* 18 to 80 years of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma
Exclusion Criteria:
* No prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy or thermotherapy. No abnormal laboratory values. No co-existing malignancies and any other significant clinical disorder or laboratory finding. | 21,417 |
Study Objectives
Natural killer/T-cell lymphoma (NKTCL) patients with relapsed/refractory disease had very poor outcome. Anti-PD-1 antibody showed promising results in response, but but the complete remission rate of was low. Some anti-PD-1 antibody based regimen showed higher and deeper response in NKTCL patients.
Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Intervention / Treatment:
DRUG: tislelizumab, azacytidine, lenalidomide, DRUG: tislelizumab, etoposide, pegaspargase
| Inclusion Criteria:
* Patients with biopsy histopathology, immunohistochemistry and EBER test meet ing the WHO 2016 diagnostic criteria for NK/T cell lymphoma.* With progressive disease after asparaginase-based combined chemotherapy* Have experienced multiple courses of PD-1/PD-L1 treatment with non-responsive or progressive disease.* PET/CT or CT/MRI with at least one measurable lesion or objectively evaluable lesion.* General ECOG score 0-3 points.* The laboratory examination within 1 week before enrollment meets the following conditions:
Blood routine: Hb>80g/L, PLT>50×109/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Blood coagulation test: plasma fibrinogen ≥1.0g/L. Heart function: LVEF≥50%, ECG did not indicate any acute myocardial infarction, arrhythmia, or atrioventricular block of degree I or more.* Signed informed consent form.* Voluntarily comply with research protocols, follow-up plans, laboratory and auxiliary examinations.
Exclusion Criteria:
* Patients with a history of pancreatitis (only patients who are planning to undergo PD1 combined with pegaspargase are excluded).* Severe infections require ICU treatment.* Combined HCV or HIV infection. Patients with HBV infection who receive antiviral treatment at the same time will not be excluded.* There are serious complications such as fulminant DIC.* Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥2, decompensated liver or kidney insufficiency, hypertension and diabetes that cannot be controlled despite active treatment, nearly 6 years old There were cardio-cerebrovascular thrombotic or hemorrhagic events within months.* Pregnant and lactating women.* Have a history of autoimmune diseases, have disease activity in the past 6 months, and are still receiving oral immunosuppressive therapy within the past three months, and the daily dose of oral prednisone is greater than 10 mg. | 11,405 |
Study Objectives
In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DIAGNOSTIC_TEST: Radiomic signature
| Inclusion Criteria:
* patients with diagnosis of NSCLC
* patients candidates for mutational status assessment
Exclusion Criteria:
* patients with age <18 years | 22,994 |
Study Objectives
This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.
Conditions: Primary Malignant Liver Neoplasm
Intervention / Treatment:
PROCEDURE: Computed Tomography (CT), PROCEDURE: Positron Emission Tomography (PET), DEVICE: 90-Yttrium (Y-90) Glass Microspheres, DIAGNOSTIC_TEST: Technetium 99mTc albumin aggregated (99mTc-MAA), PROCEDURE: Single-photon emission computerized tomography (SPECT) scan
| Inclusion Criteria:
* Patient provides written informed consent
* Patient is referred for 90Y SIRT radioembolization of liver tumor(s)
* Patient is capable of complying with study procedures
* Patient is able to remain still for duration of imaging procedure (approximately 30 minutes total for digital PET/CT)
Exclusion Criteria:
* Patient is pregnant or nursing | 272 |
Study Objectives
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of TAB08 when administered intravenously (i.v.) to patients with advanced solid malignancies.
Conditions: Solid Tumors
Intervention / Treatment:
DRUG: TAB08
| Inclusion Criteria:
* Subjects or their authorized representatives must be able to provide written informed consent.* Subjects must have histological or cytological evidence of a solid neoplasm for which standard therapy has failed or does not exist or is not available for patient due to any reason.* Subjects enrolled in the expansion cohort must have at least one measurable evaluable lesion.* Subjects must have ECOG (Eastern Cooperation Oncology Group) performance status of 0 or 1.* Subjects must be ≥ 18 years of age.* Subjects must have adequate organ function, as defined by the following criteria:
* Absolute neutrophil count (ANC) > 1,500/µL.
* Platelet count > 75,000/µL.
* Hemoglobin (Hb) > 8.0 g/dL.
* Serum creatinine of < 1.5 x upper limit of normal (ULN) or a calculated Glomerular Filtration Rate of >40 mL/min/1.73m2.
* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (< 5 x ULN for subjects with known liver metastases).* At least 2 weeks or at least 5 half-lives must have elapsed since prior treatment with chemotherapy, targeted therapy, radiotherapy, immunotherapy, or investigational anti-cancer therapy prior to study drug administration. The maximum washout period will not exceed 4 weeks. .* Subjects must have recovered from the effects of any prior surgery, radiotherapy, localized therapy, or systemic therapy to Grade 1 or lower (except alopecia or anemia - Grade 2 permitted).* Subjects have a life expectancy ≥ 3 months at study entry.* Women of childbearing potential and men with partners of childbearing potential must agree to abstain from sexual intercourse or use an effective form of contraception.
Exclusion Criteria:
* Subjects with an uncontrolled concurrent illness, including, but not limited to the following: ongoing active infection requiring systemic treatment; uncontrolled endocrine disease; diabetes mellitus or chronic obstructive pulmonary disease (COPD) requiring hospitalization within the preceding 6 months.* Subjects with uncontrolled arterial hypertension, heart failure by New York Heart Association (NYHA) Class 3 or 4, left ventricular ejection fraction (LVEF) < 50% by echocardiography, myocardial infarction, acute coronary syndrome and/or QT prolongations within the preceding 6 months or history of cerebrovascular accidents including episodes of transient ischemic attacks.* Subjects with altered mental status or psychiatric illness or social circumstances that would limit compliance with the study requirements and/or obscure the results.* Immunocompromised subjects, e.g., subjects known to be infected with human immunodeficiency virus (HIV) by medical history, and subjects with active hepatitis A, B, or C by medical history.* Subjects having untreated or symptomatic brain metastasis, or subjects with leptomeningeal disease. (Subjects with treated metastases, who are off corticosteroids and who are neurologically stable for at least 2 months may participate in the trial.)* A history of major surgery within 28 days prior to the first dose of study drug.* Subjects with history of other malignancies within the preceding 5 years (except for subjects with non-melanoma skin cancers, cervical intra-epithelial neoplasia, prostate cancer Gleason ≤ 6 and Prostate Specific Antigen (PSA) < 10 ng/mL, radically excised lobular breast carcinoma in situ or ductal breast carcinoma in situ ≤ 15 mm) unless they have undergone potentially curative therapy and have had no evidence of disease for 3 years (ie, 5 years since diagnosis, no treatment or symptoms of disease for the last 3 years).* Women who are pregnant or nursing.* Subjects with any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the opinion of the investigator, contraindicates use of the investigational drug, or may render the subject as excessively high risk for treatment complications.* Subjects with any other condition as determined by medical history, including substance abuse that, in the opinion of the investigator, would render the subject unable to cooperate in the trial or place the subject at undue risk. | 813 |
Study Objectives
The purpose of this study is to evaluate the feasibility and the effectiveness of a patient education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient education and medical oncologists.
Conditions: Breast Cancer
Intervention / Treatment:
BEHAVIORAL: therapeutic education program
| Inclusion Criteria:
* Aged over 18
* History of breast cancer
* Medical prescription for an adjuvant hormonal treatment (anti-estrogens and / or aromatase inhibitors) as monotherapy or in combination with other treatments
* Affiliated to a social security scheme
Exclusion Criteria:
* Refusal to participate, patient protected by guardianship.
* Patient unable to understand the study or unable to follow the education sessions.
* Patient with documented cognitive or psychiatric history.
* Geographical remotness (more than 100 Kms). | 20,926 |
Study Objectives
To compare the effects of volume-oriented versus flow-oriented incentive spirometry on pulmonary function tests and functional capacity in patients of upper abdominal laparoscopic surgery. Previous studies were designed to target only spirometer without focusing on its different types and their effects. This study covers the research gap and therefore is designed to observe effects of different types of spirometer on pulmonary function of patients undergoing upper abdominal laparoscopic surgery.
Conditions: Cholecystitis, Perforated Duodenal Ulcer, Diaphragmatic Hernia, Benign Pancreas Tumor, Malignant Pancreatic Neoplasm, Splenic Infarction, Splenomegaly, Choledocholithiasis, Hiatal Hernia
Intervention / Treatment:
OTHER: Volume-oriented incentive spirometry, OTHER: Flow-oriented incentive spirometry
| Inclusion Criteria:
* Patient with upper abdominal surgery (laparoscopy)
Exclusion Criteria:
* Patients who had undergone open abdominal surgery and laparoscopic obstetrics and gynecological surgery.
* Patients with unstable hemodynamic parameters (arterial pressure<100 mmHg systolic and <60 mmHg for diastolic and mean arterial Pressure (MAP) <80mmHg.
* Patients with postoperative complications requiring mechanical ventilation.
* Uncooperative patients or patients unable to understand or to use the device properly
* Recent history of lower extremity fracture | 16,866 |
Study Objectives
This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.
Conditions: Malignant Central Nervous System Neoplasm
Intervention / Treatment:
PROCEDURE: Intensity-Modulated Proton Therapy, PROCEDURE: Magnetic Resonance Imaging
| Inclusion Criteria:
* Pathologic diagnosis of central nervous system malignancy requiring craniospinal irradiation.
* Signed informed consent and assent when indicated.
Exclusion Criteria:
* Any contraindication to undergoing MRI (ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial cardiac valves or devices, electrical implants such as cardiac pacemakers or perfusion pumps). Metal fragments, shrapnel, or tattoos near the eye.
* Any major uncontrolled or poorly controlled current illness that would limit compliance with study requirements.
* Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy. | 6,195 |
Study Objectives
The purpose of this study is to evaluate the effect of the probiotic use in patients with periampullary cancers undergone curative or palliative treatment considering nutritional status, postoperative complications, infection rate, length of hospitalization and mortality.
Conditions: Periampullary Carcinoma Nos
Intervention / Treatment:
DIETARY_SUPPLEMENT: Probiotics, DIETARY_SUPPLEMENT: Sugar pill
| Inclusion Criteria:
* Patients in need of surgery for periampullary cancer
Exclusion Criteria:
* Patients submitted to periampullary surgery without pathologic confirmation of cancer
* Patients unwilling to be a part of the trial | 7,628 |
Study Objectives
This study is being performed utilizing two cycles of Paclitaxel and Carboplatin, plus low doses radiation as initial therapy prior to other treatment (surgery or radiation). The study is assessing if utilization of low doses radiation as a chemoenhancer will further increase the response rate seen with initial therapy.
Conditions: Squamous Cell Carcinoma
Intervention / Treatment:
RADIATION: Radiotherapy, DRUG: Paclitaxel, DRUG: Carboplatin
| Inclusion Criteria:
* Adult patients greater than 18 years of age.* ECOG performance status of 0, 1 or 2.* Patients with pathologically documented bulky T2, III and IV SCCHN (excluding M1 disease), within 2 months of diagnosis. Bulky T2 tumors are defined as those that have a volume of disease greater than 35 cm3 as measured by CT or MRI scan (28).* Patients will be medically fit for undergoing chemotherapy. Specifically:
1. no evidence of active angina pectoris or ventricular arrhythmia's; no myocardial infarction within the last six months. (Patients with medically controlled hypertension or congestive heart failure are eligible.)
2. an absolute neutrophil count of > 1000/uL and platelet count > 100,000/uL
3. serum total bilirubin < 1.5 mg/dL
4. Creatinine Clearance greater than 60 ml/min
Using an actual or calculated creatinine clearance using the formula:
(140 - age)x(wgt in kg)\*/(serum creatinine)x(72)\* multiply by 0.85 for females
5. if a pre-existing grade I neuropathy exists, patients must be willing to risk worsening neuropathy secondary to Paclitaxel. Patients with grade II or greater neuropathy will be excluded from study.
6. ability to give written, informed consent to participate in the trial.* Patients will have measurable disease as determined by MRI or CT scan or evaluable disease determined by panendoscopy or indirect laryngoscopy to be eligible for enrollment on this study.
Exclusion Criteria:
* Pregnant females. Males and women of childbearing potential must use effective contraception in order to prevent pregnancy during therapy.* Patients with a history of previous or current malignancy at other sites diagnosed within the last 5 years, with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain free of recurrence or metastases for greater than five years are eligible.* Patients with active infection will not be eligible for this protocol until the infection is treated and the symptoms have clinically resolved.* Patients with a history of allergy to drugs utilizing Cremophor in the formulation.* Prior chemotherapy, prior irradiation or surgery for SCCHN will not be allowed.* Patients with metastatic disease will not be eligible for this study.* Patients with grade II or greater peripheral neuropathy will be excluded from study. | 4,084 |
Study Objectives
SCLC is the most aggressive and lethal form of lung cancer, typically very sensitive to cytotoxic therapy when first diagnosed, but associated with a high incidence of tumour relapse and a very poor life expectancy. Combination chemotherapy based on cisplatin or carboplatin and etoposide represents the most widely used regimen. Despite of the high response rate, approximately 80% of patients with limited disease and nearly all patients with extended disease develop disease relapse or progression. Topotecan is, at present, the only approved second line treatment in Europe.
The search of a new therapeutic agent that could alter the natural history of SCLC would be an important goal to be reached. LBH589 (Panobinostat) is a histone deacetylase (HDAC) inhibitor available for intravenous and oral administration. LBH589 could be classified as PAN-DAC inhibitor targeting both histone and non histone proteins and as such it could be suitable for combination with cytotoxics. Three phase I dose escalation studies with both the intravenous and the oral formulation of LBH589, examining various dose schedules of administration have been conducted in advanced solid tumours and haematological malignancies.
Single agent activity was observed in phase I in patients with haematological cancer. In solid tumours one response (Hormone-refractory Prostatic Cancer) and some prolonged stabilizations have been observed with intravenous formulation. Phase II studies are now in progress.
Conditions: Small Cell Lung Carcinoma
Intervention / Treatment:
DRUG: LBH581
| Inclusion Criteria:
* Histological/cytological diagnosis of SCLC, mixed small and non small cell tumours are excluded* ≤ 2 prior chemotherapy lines* Progression after, and not during, last previous chemotherapy treatment* Age ≥ 18 and ≤ 75 years* Life expectancy of at least 3 months* ECOG Performance Status 0-1* At least one measurable lesion according to modified RECIST criteria defined as ≥ 1 lesion with longest diameter ≥ 20 mm by conventional techniques or ≥ 10 mm with spiral CT scan. In case of solitary measurable lesion, histological confirmation is not required.* Adequate haematological function:
* haemoglobin ≥ 9 g/dl
* platelet count ≥ 100,000/mm3
* neutrophils count ≥ 1,500/mm3* Adequate liver and renal functions:
* Total serum bilirubin ≤ 1.5 x UNL
* Serum creatinine ≤ 1.5 x UNL or 24 hours creatinine clearance ≥ 50 mL/min
* AST and ALT ≤ 2.5 x UNL or ≤ 5.0 x UNL if the transaminase elevation is due to hepatic involvement
* Albumin ≥ 2.5 g/dl
* Alkaline phosphatase ≤ 2.5 x UNL* Fertile patients must use effective contraception during and for ≥ 6 weeks after completion of study therapy* Ability to signed informed consent
Exclusion Criteria:
* Progression while on previous chemotherapy* Other chemotherapy treatment < 4 weeks prior to enrolment* Presence of active infection* A known history of HIV positivity* Participation to any investigational drug study < 4 weeks preceding study enrolment* Radiotherapy involving > 30% of the active bone marrow* Thoracic and brain radiotherapy < 4 weeks prior to enrolment. Palliative radiotherapy is allowed during study treatment* Presence of any serious neurological or psychiatric disorder* Impaired cardiac function, including any one of the following:
* Complete Left Bundle Branch Block or obligate use of a cardiac pacemaker or congenital long QT syndrome or history or presence of atrial or ventricular tachyarrhythmias or clinically significant resting bradycardia (< 50 beats per minute) or QTcF > 480 msec on screening ECG or Right Bundle Branch block + left anterior hemiblock (biphasic block)
* Acute MI ≤ 3 months prior to starting study drug
* Other clinically significant heart disease (e.g. congestive heart failure, previous history angina pectoris, uncontrolled hypertension, history of labile hypertension or arrhythmia, or history of poor compliance with an antihypertensive regimen)
* Any other case of current abnormal cardiac functionality or history of cardiac disease causing LVEF < 45% as determined by ECHO* Known hypersensitivity/allergic reaction to the study product* Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.* Previous or current concomitant malignancy at other site, other than basal or squamous cell carcinoma of the skin and carcinoma in situ of the uterine cervix, within 3 years.* Symptomatic or progressive brain metastases* Patients with an active bleeding diathesis or on anticoagulants Therapeutic doses of sodium warfarin (Coumadin) are not allowed. Low doses of Coumadin (e.g., ≤ 2 mg/day) for line patency are allowed* Pregnant or lactating women* Concomitant use of CYP3A4/5 inhibitors or inducers, or drug that prolong the QT interval and/or induce torsades ventricular arrythmia, where the treatment can not be discontinued or switched to a different medication prior to starting study drug.* Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GMCSF) ≤ 2 weeks prior to starting study drug.* Unable or unwilling to comply with all study procedures | 32,886 |
Study Objectives
Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent complications of long term TCVC are catheter related blood steam infections. Taurolock is a new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the number of CRBSI in children with cancer compared with children with heparin lock of their CVC.
Conditions: Bacteremia, Neoplasms
Intervention / Treatment:
DEVICE: Taurolock, DEVICE: Heparin
| Inclusion Criteria:
* Children aged 0-17 years with malignant disease requiring a tunneled central venous catheter.
Exclusion Criteria:
* No written consent from child or parents | 25,147 |
Study Objectives
The study aim is to perform a comprehensive and integrated characterization of mechanisms of primary and acquired resistance to Kadcyla in a prospective cohort of progressive/recurrent HER2-positive breast cancer patients.
Conditions: Advanced Breast Cancer
Intervention / Treatment:
| Inclusion Criteria:
* Patients are eligible to be included in the study only if they meet all of the following criteria and according to the corresponding Summary of Product Characteristics (SmPC):
* The patient has signed and dated the informed consent form (ICF) and it has been obtained before conducting any study specific procedure.* Female or male patients ≥ 18 years of age on day of signing informed consent.* Documented HER2-positive breast cancer based on local laboratory determination (preferably assessed on the most recent tumor biopsy available).* Patients with evidence of advanced disease not amenable to resection or radiation therapy with curative intent who are planned to receive Kadcyla within the approved indication in Spain: as a single agent for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:
* Received prior therapy for locally advanced or metastatic disease, or
* Developed disease recurrence during or within six months of completing adjuvant therapy* Presence of measurable disease according to RECIST 1.1 for assessment of tumor response.* Availability of tumor tissue sample from the primary tumor and/or the recurrence/metastatic site. Effort will be made to obtain a biopsy from a metastatic site in easily accessible tissues.* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.* Patient must have a life expectancy ≥16 weeks.* Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI-CTCAE v5.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion).* Negative serum pregnancy test result for women of childbearing potential and for women who have experienced menopause onset < 12 months prior to study entry.* Willingness and ability to comply with the protocol for the duration of the study including tumor and blood sample collection and undergoing the standard medical practice visits.
Exclusion Criteria:
* Patients will be excluded from the study if they meet any of the following criteria and according to the corresponding Summary of Product Characteristics (SmPC):
1. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons), within 3 weeks prior to study entry (or a longer period depending on the defined characteristics of the agents used).
2. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with brain metastases may be eligible for the study only if more than 4 weeks elapsed from treatment completion for these metastases (including radiation and/or surgery) and are clinically stable at the time of study entry.
3. Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the period of Kadcyla administration.
4. To present contraindications for the treatment with Kadcyla according to the corresponding Summary of Product Characteristics (SmPC).
5. Known hypersensitivity to Kadcyla, excipients and/or murine proteins.
6. Pregnancy or breast feeding women.
7. Persistent toxicities ( NCI-CTCAE v 5.0 grade 2) caused by previous cancer therapy (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion).
8. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
9. Known active liver disease, for example, due to hepatitis viruses B (HBV), hepatitis viruses C (HCV), autoimmune hepatic disorders, or sclerosing cholangitis.
10. History of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix and colon. A patient with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years.
11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or Kadcyla administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. | 31,269 |
Study Objectives
Radiotherapy (RT) treatment to the chest is a standard way of trying to decrease symptoms like cough or shortness of breath. Before any RT can be delivered, it must be planned, either using conventional x-rays ("fluoroscopy") or using computer tomography ("CT") scanning. This study is being done because the investigators do not know which of these two common ways of RT planning is better for balancing both treating the cancer and decreasing side effects.
Conditions: Non-small Cell Lung Cancer
Intervention / Treatment:
PROCEDURE: CT- simulation scan
| Inclusion Criteria:
* Patients with local symptoms secondary to histologically-confirmed non-small cell lung cancer
* Patients who will be receiving palliative-intent external beam radiotherapy
* Patients who are clinically appropriate for conventional radiotherapy planning
* Patients who can provide written informed consent
Exclusion Criteria:
* Patients who cannot provide written informed consent | 14,344 |
Study Objectives
This project is part of a large multicenter multidisciplinary program that will thoroughly explore the needs and difficulties of patients with BCR as well as those involved in their care. The results of this research program will propose recommendations for better structure and understand the follow up of these patients.
From the limited data in the literature, the long-term remission in patients with ovarian cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as well as somatic and mental illness; consumption is also a medical records for these patients.
In this context, our team has initiated a large case-control study to assess fatigue (identified major problem in the long-term remission in patients with ovarian cancer), QoL and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment, compared with women of the same age without ovarian cancer or serious chronic disease , from the general population.
Patients and controls complement standardized and validated self-administered questionnaire (part 1). This study investigated 215 patients in long remission from ovarian cancer compared to 215 women of the same age without cancer. Recruitment of patients is currently underway, in close collaboration with teams from the Group GINECO very involved in this project.
Following this step, an additional component is planned: it is to offer patients who participated in part 1, a specific gynecological consultation to assess in detail the effects of the treatments in order to better meet the needs of patients .dropoff window
Conditions: Epithelial Ovarian Cancer
Intervention / Treatment:
OTHER: Gynecological consultation
| Inclusion Criteria:
* Age> 18 years;
* Patients who received optimal treatment (surgery, chemotherapy ...)
* Patients with epithelial ovarian cancer after first-line treatment;
* Patients without other cancer (except basal cell skin carcinoma and breast cancer in situ);
* Patients without clinical relapse, biological or radiological documented at least 3 years after the initial treatment (from the end date of first line chemotherapy);
* The interviews treatments are not recognized in the period;
* Patients may be included regardless of the stage of cancer at diagnosis (early or late)
* Patients who have signed their written consent to participate in the part 2 of the study Vivrovaire;
* Patients who participated in part 1 of Vivrovaire study.
Exclusion Criteria:
* Psychiatric pathology can disrupt the conduct of the study or to prevent the interpretation of results;
* Persons deprived of liberty;
* Major subject to a measure of legal protection or unable to consent. | 12,138 |
Study Objectives
Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC), The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed,The aim of this study was to compare the efficacy and safety of ESD and esophagectomy in EESCC,Risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.
Conditions: Esophageal Cancer
Intervention / Treatment:
PROCEDURE: Endoscopic submucosal dissection, PROCEDURE: Esophagectomy
| Inclusion Criteria:
* Mucosal or submucosal squamous cell carcinoma of the esophagus* no lymph node involvement or distant metastasis on computed tomography (CT) or pathology;
Exclusion Criteria:
* Tis premalignant lesions (high-grade intraepithelial neoplasia;HGIN)* patients with neoadjuvant therapy* patients combined with severe diseases of other organs | 33,234 |
Study Objectives
This phase II trial is studying how well sunitinib works in treating patients with recurrent malignant gliomas. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Conditions: Adult Anaplastic Astrocytoma, Adult Diffuse Astrocytoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Adult Oligodendroglioma, Adult Pineal Gland Astrocytoma
Intervention / Treatment:
DRUG: sunitinib malate, OTHER: pharmacological study
| Inclusion Criteria:
* Stratum 1:
* Currently not receiving an enzyme-inducing anticonvulsant
* Patients receiving non-enzyme inducing anticonvulsants are eligible for this stratum
* Histologically confirmed WHO grade IV astrocytoma (glioblastoma multiforme \[GBM\]) including gliosarcoma
* Stratum 2 (USA patients only):
* Currently on stable dose of an enzyme-inducing anticonvulsant (with confirmed therapeutic serum levels) for at least 2 weeks prior to study registration including any of the following:
* Phenytoin
* Carbamazepine
* Phenobarbital
* Histologically confirmed grade IV astrocytoma (GBM), gliosarcoma, grade III astrocytoma, oligodendroglioma, or mixed oligoastrocytoma
* All patients must have unequivocal evidence of tumor progression by MRI or CT scan performed no longer than 14 days prior to study registration
* Patients undergoing surgery for progressive disease with nonmeasurable disease on post-operative MRI, ideally obtained within 48 hours of surgery, (i.e., macroscopic gross total resection) are eligible
* ECOG performance status 0-2 (Karnofsky ≥ 60%)
* Life expectancy > 3 months
* Leukocytes ≥ 3,000/μL
* Absolute neutrophil count ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Hemoglobin ≥ 9 g/dL
* Serum calcium ≤ 12.0 mg/dL
* Total bilirubin within normal institutional limits (ULN)
* AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN
* Creatinine < 1.5 X institutional ULN
* Patients must have QTc < 500 msec
* The following groups of patients are eligible provided they have New York Heart Association class II cardiac function on baseline ECHO or MUGA:
* Those with a history of class II heart failure who are asymptomatic on treatment
* Those with prior anthracycline exposure
* Those who have received central thoracic radiation that included the heart in the radiotherapy port
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
* All women of childbearing potential must have a negative pregnancy test prior to receiving sunitinib malate
* Patients with a history of QTc prolongation (defined as a QTc interval >= 500 msec), serious ventricular arrhythmia (VT or VF > 3 beats in a row) or other significant ECG abnormalities are excluded
* Patients with poorly controlled hypertension (systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg) are ineligible
* Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib malate tablets are excluded
* Patients with any of the following conditions are excluded:
* Serious or non-healing wound, ulcer, or bone fracture
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment
* History of myocardial infarction, cardiac arrhythmia, stable or unstable angina, symptomatic congestive heart failure, or coronary or peripheral artery bypass graft or stenting within 12 months prior to study entry
* Class III or IV heart failure as defined by the NYHA functional classification system
* Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infections requiring antibiotics or psychiatric illness/social situations that would limit compliance with study requirements are ineligible
* Pregnant women are excluded from this study
* Breastfeeding should be discontinued if the mother is treated with sunitinib malate
* Patients are eligible if they received up to 1 previous chemotherapy regimen
* ≥ 12 weeks must have elapsed from the completion of radiation therapy
* ≥ 4 weeks from previous non-nitrosoureas-based cytotoxic chemotherapy
* ≥ 6 weeks from any nitrosoureas
* ≥ 2 weeks from last cytostatic chemotherapy such as erlotinib hydrochloride or tamoxifen
* Patients who have undergone previous stereotactic radiosurgery, intratumoral chemotherapy, or brachytherapy are eligible if functional imaging (PET or SPECT scan, MR spectroscopy, or dynamic MRI) supports the diagnosis of recurrent tumor or recurrent disease is confirmed histologically
* Concurrent steroids allowed provided the patients is on a stable or decreasing dose for at least 7 days prior to baseline tumor assessment (MRI and/or CT scan)
* Patients who have received prior treatment with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, or VEGF Trap) are ineligible
* Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin or enoxaparin are excluded, although warfarin doses of up to 2 mg daily are permitted for prophylaxis of thrombosis
* Low molecular weight heparin is permitted provided the patient's PT INR is < 1.5
* Use of agents with proarrhythmic potential (e.g., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, or flecainide) is not permitted during the study
* No other investigational or commercial agents or non-investigational therapy designed to treat the brain malignancy (i.e., radiation therapy, systemic or intratumoral chemotherapy, biological agents, immunotherapy, or hormonal therapy) is allowed during the study period
* HIV-positive patients on combination antiretroviral therapy are ineligible
Exclusion Criteria:
* History of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
* Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or radiation therapy within 12 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* At least 4 weeks must have elapsed since any major surgery | 19,376 |
Study Objectives
In this study, patients diagnosed with a pathology-proven malignancy of the head and neck will receive a routine clinical activity of 18F-FDG ((18)F-luorodeoxyglucose) before undergoing standard of care surgical resection of the malignancy. Following the resection, the 18F-FDG-infused malignancy will be investigated utilizing a novel high-resolution Positron Emission Tomography (PET) and Computed Tomography (CT) scan. Slicing of the malignancy will be followed by additional PET/CT-scanning and autoradiography of the sliced specimen. The results found during image analysis will be compared to the results of the gold standard of histopathology. As this is no approved way of assessing the tumour's margin, the conclusion of the scan will not be used as a method for changing the patients' treatment.
Conditions: Head and Neck Neoplasms, Thyroid Neoplasm, Skin Neoplasm
Intervention / Treatment:
DIAGNOSTIC_TEST: high-resolution PET-CT specimen imaging.
| Inclusion Criteria:
* Patients with one or multiple pathologically proven malignancies in the head and neck region (targeted lesions), independent of origin and stage.
* Patient is planned for the surgical resection of the targeted lesion.
* Age ≥ 18 years.
* Karnofsky performance scale ≥30
* Patient has given informed consent according to the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines in accordance with the declaration of Helsinki.
Exclusion Criteria:
* Patient is planned for a treatment regimen which does not include standard surgical resection of the targeted lesion.
* Pregnant or actively lactating women.
* Blood glucose level ≥ 200mg/dl or more on the day of surgery. | 21,142 |
Study Objectives
The investigators are conducting a project to provide a new type of resource called "hand lettering" to patients receiving chemotherapy. This is a type of art therapy. The goal of this project is to understand if it is feasible to use art-therapy and to describe anxiety before and after completing hand-lettering.
Conditions: Anxiety
Intervention / Treatment:
BEHAVIORAL: Breathing and journaling exercise, OTHER: Art-therapy
| Inclusion Criteria:
* Adult patients (>age 18) with a cancer diagnosis receiving oral or IV chemotherapy at Dana-Farber on Yawkey 10.
* Able to read and speak English
* Has a minimum appointment time of 60 minutes
Exclusion Criteria:
*Individuals with visual impairment or blindness will be excluded | 19,032 |
Study Objectives
Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced melanoma or metastatic TNBC
Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination
Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint inhibitors (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune systems in those subjects who have failed 1st line therapy
The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12 subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer (TNBC) subjects. The safety criterion of ≤ 4 (or ≤ 33%) subjects with Grade 3/4 adverse events in Cycle 1 within either tumor type must be met in order to proceed to Stage 2. The starting dose is 4 mg/kg for Imprime PGG. In the event there are a total of \> 4 (or \> 33%) of subjects with Grade 3/4 adverse events in Cycle 1, the dose of Imprime PGG will be reduced to 2 mg/kg, and Stage 1 will be repeated at a dose of 2 mg/kg with an additional cohort of n=12 subjects. For the dose that meets the safety criterion in Stage 1, at least 1 response in melanoma subjects and 2 responses in TNBC subjects amongst the 12 subjects within each tumor type must be observed in order to proceed to Stage 2.
Stage 2 will enroll an additional 17 subjects with melanoma, and 30 subjects with TNBC. For the dose that meets the Stage 1 safety criterion, success will be declared if at least 4 amongst the total of up to 29 subjects with melanoma, and 13 amongst the total of up to 42 subjects with TNBC achieve an objective response.
Conditions: Advanced Melanoma, Triple-Negative Breast Cancer
Intervention / Treatment:
BIOLOGICAL: Imprime PGG, DRUG: Pembrolizumab
| Inclusion Criteria:
* Have signed an informed document prior to any study-specific procedures or treatment* Be ≥ 18 years of age at time of consent* For Melanoma Subjects: Have histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic (Stage IV) melanoma not amenable to local therapy, and irrespective of PD-L1 status* For TNBC Subjects: Have histologically or cytologically confirmed diagnosis of metastatic (Stage IV) TNBC, and irrespective of PD-L1 status. TNBC is defined as negative immunohistochemistry (IHC) assays for Estrogen Receptor (ER), and Progesterone Receptor (PR), and HER2 negative (IHC 0 or 1+, or 2+ by IHC confirmed negative by FISH)* Have documented objective radiographic or clinical disease progression after PD-1/PD-L1 +/- anti-CTLA-4 inhibitor therapy (melanoma) or after at least 1 line of chemotherapy for metastatic disease (TNBC)* Have resolution of all previous treatment-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to Grade 2) or alopecia. If subject received major surgery or radiation therapy of > 30 Gy, must have recovered from the toxicity and/or complications from the intervention.* Have at least one radiologically measurable lesion as per RECIST v1.1 defined as a lesion that is at least 10 mm in longest diameter or lymph node that is at least 15 mm in short axis imaged by CT scan or MRI and obtained by imaging within 28 days prior to start of study treatment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.* Have peripheral blood levels of IgG anti-β-glucan antibody (ABA) of ≥ 20 mcg/mL as determined by an ELISA test within 28 days prior to start of study treatment* Be willing to consider providing fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality, for assessment of biomarker status. Repeat samples may be required if adequate tissue is not provided. Newly obtained biopsy specimens are preferred to archived samples and formalin-fixed, paraffin-embedded block specimens are preferred to slides.
Note: Information on 1 tumor biopsy sample is mandatory and is as follows: (1) To determine eligibility, historical (diagnostic) tumor biopsy official pathology report +/- an archival sample. Additional biopsy samples, preferably obtained from the same localized region, are highly desirable when feasible at the following time points: (2) Sample before the first dose of study treatment, (3) Sample after completion of Cycle 2 but before the start of Cycle 3 dosing, and (4) Sample either at the time of response or at the End of Study Visit (if no response).* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 14.3)* Have life expectancy of 3 months or greater as determined by the treating physician* Have adequate organ function (all screening labs should be performed within 15 days prior to treatment initiation):
1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 x ULN
2. Aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
3. Alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases* Have adequate renal function as defined by the following criteria:
Creatinine ≤ 1.5 x ULN and CrCl ≥ 30 ml/min per Cockcroft Gault formula:* Have adequate hematologic function, defined as meeting all of the following criteria:
1. Hemoglobin ≥ 9 g/dL (uncorrected by RBC transfusion)
2. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
3. Platelet count ≥ 100 × 109/L* Have adequate coagulation functioning within 15 days prior to start of study treatment, defined by either of the following criteria:
1. INR < 1.5 × ULN
2. OR for subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the Investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed 1.5 × ULN if that is the goal of anticoagulant therapy.
3. Activated Partial Thromboplastin Time (aPTT) < 1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants* Female subjects of childbearing potential as defined in Section 5.7.2 must 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.* If of childbearing potential as defined in Section 5.7.2, must be willing to use an adequate method of contraception (see Section 5.7.2) from the first dose of study medication through 120 days after the last dose of study medication* Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures
Exclusion Criteria:
* Has disease that is suitable for local therapy administered with curative intent* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment* Has a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.* Has known history of active tuberculosis* Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)* Has known active Hepatitis B (eg, HBsAg reactive) or Hepatitis C (eg, HCV RNA \[qualitative\] is detected* Has a history of clinically severe autoimmune disease, or history of organ transplant* Has a history of ocular melanoma* Has known hypersensitivity to baker's yeast* Had previous exposure to Betafectin® or Imprime PGG* Has hypersensitivity to pembrolizumab or any of its excipients* Had a prior anti-cancer monoclonal antibody (except immune CPI in the case of melanoma subjects) within 30 days prior to start of study treatment, or failure to recover to CTCAE Grade 1 or better from the adverse events of prior therapies* Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Study Day 1 or who has not recovered from adverse events due to a previously administered agent or major surgery* Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF, or recombinant erythropoietin) within 4 weeks prior to Study Day 1* Has known additional 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.* Has known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 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.* Has active autoimmune disease requiring systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteriod replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.* Has evidence of (non-infectious) pneumonitis that required steroids or current pneumonitis* Has a history of interstitial lung disease* Has an active infection requiring systemic therapy* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator* Has a clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome within ≤180 days prior to start of study treatment, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification* Has a known psychiatric or substance abuse disorder(s) that would interfere with informed consent or cooperation with the requirements of the trial* 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* With TNBC has received prior therapy with an anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-PD-L2 agent* Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted | 9,633 |
Study Objectives
RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with kidney cancer that cannot be removed by surgery.
Conditions: Kidney Cancer
Intervention / Treatment:
DRUG: sunitinib malate, PROCEDURE: conventional surgery
| Inclusion Criteria:
* Histologically or cytologically confirmed renal cell carcinoma (any histology) based on prior biopsy or biopsy performed and reviewed at Cleveland Clinic Foundation. This can include pathology read as adenocarcinoma consistent with renal origin.
* Unresectable primary tumor due to any of the following factors or various combinations thereof:
* Large tumor size (> 15 cm)
* Bulky lymphadenopathy (> 4 cm or encasement of renal vessels or great vessels)
* Venous thrombosis (high level/invasive disease requiring inferior vena cava reconstruction or hypothermic circulatory arrest)
* Proximity to vital structures (e.g., mesenteric vasculature)
* Any one of these factors may or may not constitute unresectability, but for consideration for this trial, the surgical and medical oncologist must agree that the particular constellation of findings for the patient under consideration would likely entail a low probability (<50%) that the tumor would be resectable (with negative margins) or that the potential morbidity associated with an attempt at surgical resection would not be clinically acceptable. The numerical thresholds noted above are only a guideline and the clinical judgment of the surgeon and medical oncologist will determine unresectability.
* Patients with history of brain metastases can be enrolled 2 weeks following the completion of gamma knife or whole brain radiotherapy.
* ECOG performance status (PS) 0-1 or Karnofsky PS >=70%
* Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 times upper limit of normal (ULN)
* Total Serum Bilirubin ≤ 1.5 times ULN
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
* Serum calcium ≤ 12.0 mg/dL
* Creatinine ≤ 2.5 mg/dL
* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
* The presence of any of the following will exclude a patient from study enrollment:
* Prior systemic treatment for RCC.
* Evidence of bleeding diathesis or coagulopathy. Patients with hematuria from the primary renal tumor are eligible provided all other eligibility criteria are met.
* Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism.
* Hypertension that cannot be controlled by medications to < 160/90 mmHg.
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
* Pregnancy or breastfeeding.
* Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. | 8,510 |
Study Objectives
Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.
Conditions: Gastrointestinal Stromal Tumor
Intervention / Treatment:
PROCEDURE: Conventional Surgery, DRUG: Imatinib Mesylate
| Inclusion Criteria:
* Histologically confirmed malignant gastrointestinal stromal tumor
* Potentially resectable primary disease
* Potentially resectable recurrent disease
* Local or intra-abdominal/pelvic metastatic disease
* Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
* Primary disease must be visceral, intra-abdominal, or pelvic in origin
* At least 1 unidimensionally measurable lesion
* At least 5 cm for primary disease
* At least 2 cm for recurrent disease
* At least 1 viable core biopsy tumor specimen obtained within 8 weeks before registration
* Performance status - Zubrod 0-2
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT/AST no greater than 2.5 times ULN
* No uncontrolled chronic liver disease
* Creatinine no greater than 1.5 times ULN
* No uncontrolled chronic renal disease
* No New York Heart Association class III or IV cardiac disease
* Must be able to lie still in the PET scanner for approximately 1-2 hours
* No uncontrollable hyperglycemia
* No medical or psychological condition that would preclude study participation
* No severe or uncontrolled medical disease
* No active uncontrolled infection
* No known or suspected hypersensitivity to any component of the study drug
* Any prior malignancy is allowed provided patient remains disease free from that malignancy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 3 months after study participation
* At least 28 days since prior biologic therapy
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
* At least 28 days since prior chemotherapy
* At least 28 days since prior radiotherapy
* See Disease Characteristics
* At least 28 days since prior investigational drugs
* At least 28 days since prior imatinib mesylate
* No concurrent therapeutic doses of warfarin
* Concurrent low-molecular weight heparin or mini-dose warfarin (1 mg per day) prophylaxis is allowed | 8,224 |
Study Objectives
Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of tipifarnib in treating older patients who have previously untreated acute myeloid leukemia
Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Erythroid Leukemia (M6), Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Cellular Diagnosis, Adult Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: tipifarnib, OTHER: laboratory biomarker analysis
| Inclusion Criteria:
* Pathologic confirmation of the diagnosis of AML (>= 20% marrow blasts)
* ECOG performance status 0 or 1
* Patients must be able to give informed consent
* SGOT and SGPT =< 2.5 x normal limits (grade 1)
* Serum creatinine =< 1.5 x normal limits (grade 1)
* AML (any of the following):
* Newly diagnosed AML in adults >= 75 years
* Newly diagnosed AML arising from MDS in adults >= 65 years
* Hyperleukocytosis with >= 30,000 leukemic blasts/uL
Exclusion Criteria:
* Acute promyelocytic (FAB M3) subtype
* Previously treated with chemotherapy for leukemia (except for hydroxyurea)
* Disseminated intravascular coagulation (laboratory or clinical)
* Active central nervous system leukemia
* Concomitant radiation therapy, chemotherapy, or immunotherapy; previous therapy for another malignancy is permitted, provided that at least 1 month has occurred since patient received any of these treatments
* Intrinsic impaired organ function (as stated above)
* Symptomatic neuropathy (grade 2 or worse)
* Known allergy to imidazole drugs, such as ketoconazole, miconazole, econazole, teconazole, clotrimazole, fenticonazole, isoconazole, sulconazole, or ticonazole
* Physical or psychiatric conditions that in the estimation of the principal investigator (PI) or designee place the patient at high risk of toxicity or non-compliance, e.g. severe congestive heart failure (CHF), unstable angina, or poorly controlled psychosis | 3,341 |
Study Objectives
This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.
Conditions: Malignant Melanoma
Intervention / Treatment:
PROCEDURE: Wide Local Excision
| Inclusion Criteria:
* Biopsy proven T2 malignant melanoma.
* Eastern Cooperative Oncology Group (ECOG) score of 0-2.
Exclusion Criteria:
* Visible additional disease that suggests a greater than T2 malignant melanoma
* Unable to tolerate general anesthesia
* Evidence of distant metastatic disease
* Melanoma located on face or digits | 5,550 |
Study Objectives
This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Placebo, DRUG: Platinum chemotherapy (cisplatin or carboplatin), DRUG: erlotinib [Tarceva], DRUG: gemcitabine
| Inclusion Criteria:
* adult patients, >=18 years of age;
* advanced (stage IIIB/IV)non-small cell lung cancer;
* measurable disease;
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Exclusion Criteria:
* prior exposure to agents directed at the HER axis;
* prior chemotherapy or systemic anti-tumor therapy after advanced disease;
* unstable systemic disease;
* any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
* brain metastasis or spinal cord compression. | 9,056 |
Study Objectives
Diagnostic trial to study genetic differences in patients who have Ewing's sarcoma. Genetic testing may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy.
Conditions: Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Intervention / Treatment:
OTHER: laboratory biomarker analysis
| Inclusion Criteria:
* Newly diagnosed or recurrent Ewing's sarcoma
* Availability of the following specimens:
* Paraffin-embedded block or 20 unstained slides and 1-3 thick (50 micron) sections from initial biopsy
* Pretreatment serum and whole blood
* Concurrent therapy is not required | 8,591 |
Study Objectives
To compare the anti-tumor activity of everolimus and sunitinib in subjects with metastatic renal cell carcinoma (mRCC) with non-clear cell pathology.
Conditions: Advanced Non-clear Cell Renal Cell Carcinoma
Intervention / Treatment:
DRUG: Everolimus, DRUG: Sunitinib
| Inclusion Criteria:
* Histologically confirmed advanced Renal Cell Carcinoma (RCC), with non-clear cell pathology.* RCC tumor tissue available for correlative sciences, from either primary or metastatic site or both.* At the time of screening, at least 4 weeks since prior palliative radiation therapy and/or major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 4.0) Grade 1.* Subject must have radiographic evidence of metastatic disease with at least 1 measurable per RECIST 1.1 criteria (Attachment 1)\].* Age > 18 years.* Adequate laboratory values* Karnofsky Performance Status ≥ 60 (Attachment 2).* Life expectancy of at least 3 months.* Written, signed, dated, and witnessed Institutional Review Board (IRB) or Institutional Ethics Committee (IEC) approved informed consent form (ICF) before any screening procedures are performed.
Exclusion Criteria:
* Subjects with a history of or active central nervous system (CNS) metastases.* Prior systemic therapy for RCC, including mTOR and anti-angiogenic therapy, chemotherapy, biologic or experimental therapy.* Subjects with collecting duct, medullary, small cell, oncocytoma, or lymphoma-type pathology.* Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers.* Major surgery, open biopsy, traumatic injury, or radiotherapy within 4 weeks of the screening visit.* Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.* Presence of a non-healing wound or ulcer.* Grade 3 hemorrhage within the past month.* Hypertension with systolic blood pressure of >180 mm Hg and/or diastolic pressure >100 mm Hg.* Subjects with American Heart Association (AHA) Class 2-4 heart disease or any history of congestive heart failure with an ejection fraction <50%, or history of unstable angina, myocardial infarction, coronary artery bypass graft, cerebrovascular accident, transient ischemic attack, or pulmonary embolism within 6 months of entry.* Diabetes mellitus with glycosylated hemoglobin A1c (HbgA1c) > 10% despite therapy.* A history of interstitial pneumonitis.* Subjects with active autoimmune disorder(s) being treated with immunosuppressive agents within 4 weeks prior to the screening visit.* Subjects receiving immunosuppressive agents and those with chronic viral/bacterial/fungal illnesses such as human immunodeficiency virus (HIV).* Patients who have receive immunization with attenuated live vaccines within one week of study entry or during study period.* Patients with active infection(s), active antimicrobial therapy or serious intercurrent illness.* History of other prior malignancy in past 5 years.* Pregnant or nursing women.* Major medical/psychiatric illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study, including inability to absorb oral medications and history of noncompliance to medical regimens.* Known hypersensitivity to any of the components in everolimus or sunitinib product* Subjects taking agents that significantly prolong the QTc interval are not eligible.* Proteinuria with a spot urine protein/creatinine ratio >2 or 24 hour urine protein >2 grams per 24 hours.* Severely impaired lung function as defined as spirometry and Carbon Monoxide Diffusing Capacity (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air.* Advanced liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C). | 38,421 |
Study Objectives
The goal of this clinical research study is to find out if Procrit (epoetin alfa) will help decrease the need for blood transfusions in patients who have Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) and are receiving chemotherapy. Researchers also want to learn about the remission rates (rates of recovery) in patients with cancer who have received treatment with epoetin alfa. The safety and effectiveness of this therapy will also be studied.
Conditions: Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia
Intervention / Treatment:
DRUG: Procrit
| Inclusion Criteria:
* Patients with a diagnosis of AML or high-risk MDS (based on International Prognostic Scoring System (IPSS): refractory anemia with excess of blasts (RAEB) or RAEB in transformation \[RAEB-t\]) receiving frontline induction chemotherapy with any high dose or conventional dose cytarabine-containing regimen or clofarabine-containing regimen at MD Anderson Cancer Center.
* Patients must be enrolled on the study within two weeks of the start of induction chemotherapy.
* Patients with documented iron, vitamin B12, or folate deficiency are eligible, but should receive replacement therapy while on study.
* Understand and voluntarily sign an informed consent form.
Exclusion Criteria:
* Patients with prior treatment with any form of erythropoietin within the previous month.
* Patients with uncontrolled hypertension (> or =140/90), uncontrolled, clinically significant cardiac arrhythmias, or history of pulmonary embolism or thrombosis within the last 5 years.
* New onset (within 3 months prior to randomization) or poorly controlled seizures.
* Patients with known hypersensitivity to the active substance or any of the excipients.
* Pregnant or lactating women.
* Acute Erythroleukemia (M6 French-American-British (FAB) classification)
* Hemoglobin greater than or equal to 10g/dl
* Patients with head and neck cancer receiving radiation therapy when erythropoiesis-stimulating agents (ESAs) were given to maintain hemoglobin levels of more than 12 g/dL.
* Patients with metastatic breast cancer receiving chemotherapy when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
* Patients with chronic kidney failure when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
* Patients requiring major surgery would be taken off study due to a higher chance of blood clots being reported while taking ESAs. | 18,842 |
Study Objectives
This randomized phase II trial studies how well ficlatuzumab with or without cetuximab works in treating patients with head and neck squamous cell carcinoma that has come back or spread to other places in the body and resistant to cetuximab treatment. Monoclonal antibodies, such as ficlatuzumab and cetuximab, may block growth signals that lets a tumor cell survive and reproduce, and helps the immune system recognize and fight head and neck squamous cell carcinoma.
Conditions: Head and Neck Basaloid Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Unknown Primary Origin, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IV Oropharyngeal Squamous Cell Carcinoma, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVA Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVB Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVC Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma, Head and Neck Cancer, Oropharyngeal Cancer, HNSCC, Stage IV Lip and Oral Cavity Squamous Cell Carcinoma
Intervention / Treatment:
BIOLOGICAL: Cetuximab, DRUG: Ficlatuzumab
| Inclusion Criteria:
* Patients must have histologically confirmed HNSCC from any primary site, except nasopharyngeal if World Health Organization (WHO) Type III (non-keratinizing and Epstein-Barr virus (EBV)-positive)).
Eligible histologies include:
* Basaloid, poorly differentiated, and undifferentiated carcinoma histologies.
* Nasopharyngeal carcinoma, WHO Type I and II (keratinizing, non-EBV positive).
* Paranasal sinus, lip and external auditory canal sites.
* Squamous cell carcinoma of unknown primary, clearly related to the head and neck.
Note: Documentation of primary site diagnosis must be submitted with the registration request.
* Patients must have recurrent and/or metastatic disease, fulfilling at least one of the criteria defined below:
* Incurable disease as assessed by surgical or radiation oncology;
* Metastatic (M1) disease;
* Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity. Note: Patients who decline radical surgery are eligible.
* For patients with oropharyngeal primary site or unknown primary site only: Patients must have known tumoral HPV status (p16). (Acceptable standards include p16 immunohistochemistry (where a tumor is classified as p16-positive when showing diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells) and/or assessment of HPV DNA.) Note: For these subjects, documentation of p16 status must be submitted with the registration packet.
* Patients must be cetuximab-resistant by fulfilling at least one of the two criteria defined below:
* Disease persistence or recurrence within 6 months of completing definitive radiotherapy with concurrent cetuximab for locally advanced disease. Induction chemotherapy, if given, may or may not have included cetuximab.
* Disease progression during, or within 6 months, of cetuximab treatment in the recurrent and/or metastatic setting.
Note: Prior cetuximab exposure may have occurred in any line of therapy (first line, second line, etc.) and is not required to be the most recent therapy received.
* Patients must be platinum-resistant or platinum-ineligible by fulfilling at least one of the three criteria defined below:
* Disease persistence or recurrence within 6 months of completing definitive radiotherapy for locally advanced disease, where platinum chemotherapy was administered as a component of induction and/or concurrent systemic treatment.
* Disease progression during, or within 6 months, of treatment with platinum chemotherapy (e.g., carboplatin or cisplatin) in the recurrent and/or metastatic setting.
* The patient is not an acceptable candidate for platinum chemotherapy due to medical comorbidities, in the judgment of the local investigator.
Note: Prior platinum exposure may have occurred in any line of therapy (first line, second line, etc.) and is not required to be the most recent therapy received.
* Patients must have prior exposure to an anti-PD1 (programmed cell death protein 1) or anti-PDL1 (programmed cell death ligand 1) monoclonal antibody (mAb), if eligible for immunotherapy in the judgment of the local investigator.
Note: Prior exposure to investigational immunotherapies, including anti-CTLA4 (cytotoxic T-lymphocyte-associated antigen 4), anti-OX40, anti-CD40 (cluster of differentiation 40), anti-CD27, anti-TNFR (tumor necrosis factor receptor) antibodies or other investigational immunotherapies, is acceptable.
* Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at time of informed consent (see Appendix B).
* Patients must be age ≥ 18 years.
* Patients must consent to a research biopsy of tumor tissue at baseline, for conduct of correlative studies. In cases where a fresh biopsy is not feasible (i.e., if an accessible tumor site cannot be biopsied with acceptable clinical risk), archival tissue may be submitted instead, after discussion with and approval by the Sponsor-Investigator.
* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1 (see section 6) per scan within 28 days prior to registration.
* Patients must have adequate electrolytes, liver, renal, and hematology function as defined below within 28 days of registration:
* Absolute neutrophil count (ANC) ≥ 1500/mm3
* Platelet count (PLT) ≥ 75,000/mm3
* Creatinine clearance ≥ 30 mL/min per estimated by the Cockraft-Gault formula:
* Calculated Creatinine Clearance = \[(140-age) X (actual body weight in kg) X (0.85 if female)\]/(72 X serum creatinine)
\* Total bilirubin ≤ 1.5 times upper-limit of normal (ULN)
* AST (aspartate aminotransferase) ≤ 3 times ULN
* ALT (alanine aminotransferase) ≤ 3 times ULN
* Magnesium ≥ 1.2 mg/dL or 0.5 mmol/L
* Corrected Calcium ≥ 8.0 mg/dL or 2.0 mmol/L
* Potassium ≥ 3.0 mmol/L (Note: Patients may be supplemented to achieve acceptable electrolyte values.)
* Serum albumin ≥ 25 g/L (≥ 2.5 g/dL)
* Patients must sign written informed consent prior to beginning study screening procedures. Patients must have the ability to understand and the willingness to sign a written informed consent document.
* Women of child-bearing potential (WOCBP) must agree to have a pregnancy test within 14 days prior to registration and a repeated test within 3 days of the first dose of ficlatuzumab.
* Patients must agree to use highly effective contraceptive measures while on study and for 60 days after the last dose of study drug. This includes: Men of reproductive potential AND women of childbearing potential.
* Effective birth control includes (a) intrauterine device (IUD) plus one barrier method; or (b) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
Exclusion Criteria
* Nasopharyngeal primary site if WHO Type III (non-keratinizing and EBV-positive as established at the local site).
* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent.
* Prior treatment with an HGF/cMet inhibitor such as rilotumumab, crizotinib, MetMAb, or tivantinib (ARQ197).
* Uncontrolled central nervous system (CNS) metastases, including leptomeningeal metastases, are not allowed.
Note: Subjects with previously treated brain metastases will be allowed if the brain metastases have been stable without steroid treatment for at least 2 weeks (radiotherapy or surgery).
* Failure to recover to Grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy, with the exception of:
* Alopecia,
* Grade ≤ 2 peripheral neuropathy,
* Grade ≤ 2 cetuximab-related rash or other skin changes,
* Hypomagnesemia (acceptable values detailed in the exclusion criteria below),
* Hypokalemia (acceptable values detailed in the exclusion criteria below), and
* The acceptable ANC and PLT inclusion criteria values above.
* Treatment with cetuximab 2 weeks prior to the first dose of study drug. A washout period of 2 weeks from prior cetuximab is required if applicable.
* Treatment with cytotoxic chemotherapy, targeted therapy, immunotherapy or investigational drug 3 weeks prior to the first dose of study drug. A washout period of 3 weeks from any prior cytotoxic chemotherapy, targeted therapy, immunotherapy or investigational drug is required, if applicable.
* Significant underlying pulmonary disease, including pulmonary hypertension or interstitial pneumonitis.
* Peripheral edema ≥ Grade 2 per NCI-CTCAE version 4.0.
* Significant cardiovascular disease, including:
* Cardiac failure New York Heart Association (NYHA) class III or IV.
* Myocardial infarction within 6 months prior to registration.
* Severe or unstable angina within 6 months prior to registration.
* History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation).
* Cardiac arrhythmia requiring anti-arrhythmic medication(s). (Beta-blockers, calcium channel blockers, and digoxin administered for the purpose of rate control of supraventricular tachycardia, including atrial fibrillation and atrial flutter, are not classified as anti-arrhythmic medications for purposes of trial eligibility.)
* Significant thrombotic or embolic events within 28 days prior to registration. (Significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack (TIA). Catheter-related thrombosis is not a cause for exclusion. Diagnosis of deep vein thrombosis or pulmonary embolism is allowed if it occurred > 28 days prior to registration and the patient is asymptomatic and stable on anti-coagulation therapy.)
* Any other medical condition (e.g., alcohol abuse) or psychiatric condition that, in the opinion of the local Investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results.
* History of second malignancy within 2 years prior to registration except:
* Excised and cured non-melanoma skin cancer,
* Carcinoma in situ of breast or cervix,
* Superficial bladder cancer,
* Stage I differentiated thyroid cancer that is resected or observed,
* pT1a /pT1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection, or
\* cT1a/cT1b prostate cancer treated with brachytherapy or external beam radiation therapy with normal PSA since radiation.
* Not completely recovered from any previous surgery. Note: Complete recovery is in the opinion of the treating investigator. Consult the Sponsor-Investigator, if needed.
* Active systemic infection requiring systemic antibiotics or antifungals within 7 days prior to first dose of study drug, except tetracycline family antibiotics (tetracycline, doxycycline, minocycline) administered for the management of cetuximab-related rash may be continued per the Investigator's judgment.
Note: Active topical infections (for example oral thrush) do not exclude a subject even if treated with systemic antibiotics or systemic antifungals.
* History of severe infusion reaction to cetuximab or a monoclonal antibody.
* Known to be Human immunodeficiency virus (HIV) positive. Note: HIV testing is not required for entry into this protocol.
* Women who are pregnant or breastfeeding. (A negative urine pregnancy test must be confirmed within 14 days of registration and repeated within 3 days of the first dose of study drug.) | 32,958 |
Study Objectives
This is an open-label, multi-center, dose-finding study of tivozanib administered in combination with capecitabine. During the dose-escalation portion, sequential cohorts of subjects with advanced solid tumors will be enrolled in order to establish the maximum tolerated dose (MTD). If the MTD is not reached, the recommended Phase 2 dose (RP2D) will be determined. In the expansion cohort, subjects with locally advanced or metastatic breast or colon cancer will be enrolled at MTD (or RP2D) to further evaluate safety and activity of this combination in these tumor types.
Conditions: Advanced Solid Tumors, Locally Advanced or Metastatic Breast or Colorectal Cancer
Intervention / Treatment:
DRUG: tivozanib (AV-951) and capecitabine (Xeloda®)
| Inclusion Criteria:
* Age 18 years or older, of either sex, and of any race.* Histologically or cytologically confirmed solid tumor malignancy.* Dose escalation cohorts: Advanced solid tumor malignancy (locally advanced or metastatic) that has recurred or progressed following standard therapy or for which no standard therapy currently exists, or for which subject is not a candidate for - standard therapy, or is unwilling to undergo standard therapy.* MTD expansion cohort: Subjects must have locally advanced or metastatic breast or colorectal cancer with or without prior systemic therapy.* ECOG performance ≤ 2 (Appendix B) and life expectancy ≥ 3 months.* Disease that is not amenable to curative surgical intervention, due to either non-resectability of the tumor or medical contraindications.* Subjects enrolled in the MTD expansion cohort must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0.* At least 4 weeks since :
* Vascular endothelial growth factor (VEGF) or VEGF receptor directed therapy
* Chemotherapy (6 weeks since prior mitomycin C or nitrosoureas)
* Immunotherapy (eg, IL-2, IFN, etc.) or biological therapy (eg, monoclonal antibodies)
* Investigational agents* At least 2 weeks since:
* Systemic hormonal therapy (with the exception of hormone replacement therapy or low dose steroid therapy as described in Drugs and Treatments to be Excluded)
* Herbal preparations (including daily multivitamin/mineral supplements containing herbal components)* At least 2 weeks since prior radiotherapy to ≤ 25% of bone marrow, or at least 4 weeks since prior radiotherapy to > 25% of bone marrow.* If female and of child bearing potential, documentation of negative pregnancy test prior to enrollment.* Sexually active pre-menopausal female subjects (and female partners of male subjects) must use adequate contraceptive measures, while on study and for 30 days after the last dose of study drug. All fertile subjects (and their partners) must agree to use a highly effective method of contraception. Effective birth control includes (a) IUD plus one barrier method; or (b) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). (Note: Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are not considered effective for this study.)* Adequate hematologic function as evidenced by Hg ≥ 9g/dL, WBC ≥ 3000 per mm3, ANC ≥ 1500 per mm3 and platelet count ≥ 100,000 per mm3.* Adequate hepatic function as evidenced by a serum bilirubin level ≤1.5 × ULN (except with known Gilbert's Syndrome) and serum AST/ALT levels ≤2.5 × ULN (or ≤5 × ULN for subjects with known hepatic metastasis).* Adequate renal function as evidenced by a serum creatinine level ≤ 1.5 × ULN (subjects with a serum creatinine level >1.5 x ULN with a calculated creatinine clearance > 50 mL/min according to Cockcroft-Gault equation will be eligible).* Proteinuria ≤3+ by urinalysis or urine dipstick (subjects with proteinuria >3 + may undergo a 24-hour urine protein and will be eligible if protein is <2 g/24hrs)* Adequate coagulation parameters: PTT ≤ 1.5 x ULN and INR ≤ 1.5* Ability to give written informed consent and comply with protocol requirements.
Exclusion Criteria:
* 1. Primary CNS malignancies or CNS metastases; subjects with previously treated brain metastasis will be allowed if the brain metastasis has been stable without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery). Subjects with symptoms of CNS metastases or history must have a CT or MRI scan including the brain during Screening.
2. Significant cardiovascular disease, including:
* Active clinically symptomatic left ventricular failure
* Uncontrolled hypertension: Systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg on 2 or more antihypertensive medications. Note: Initiation or adjustment of antihypertensive medication(s) is permitted during the screening period, in order to control a subject's BP prior to initiating treatment. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The SBP / DBP values from each blood pressure assessment must be ≤ 140/90 mmHg in order for a subject to be eligible for the study
* Myocardial infarction, severe or unstable angina within 6 months prior to administration of first dose of study drug
* History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation)
* Cardiac arrhythmias requiring anti-arrhythmic medications
* History of coronary or peripheral artery bypass graft within 6 months
3. Significant thromboembolic or vascular disorders within 6 months prior to first dose of study drug; this does NOT include catheter-related thrombosis. Significant thromboembolic or vascular disorders include but are not limited to:
* Deep vein thrombosis
* Pulmonary embolism
* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
* Symptomatic peripheral vascular disease
4. Subjects with non-healing wounds, active peptic ulcers, or unhealed bone fractures.
5. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
6. Known hypersensitivity to fluoropyrimidine therapy or to 5-fluorouracil.
7. Known inability to tolerate capecitabine (Xeloda®) due to unacceptable toxicities.
8. Serious active infection, (including active Hepatitis B or Hepatitis C) or infection requiring parenteral antibiotics.
9. Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.
10. Significant bleeding disorders within 6 months prior to first dose of study drug, including but not limited to:
* Hematemesis, hematochezia, melena or other gastrointestinal bleeding
* Hemoptysis or other pulmonary bleeding
* Hematuria or other genitourinary bleeding
11. Currently active second primary malignancy, including hematologic malignancies (leukemia, lymphoma, multiple myeloma, etc.), other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer and ductal or lobular carcinoma in situ of the breast. Subjects are not considered to have a currently active malignancy if they have completed anti-cancer therapy and have been disease free for >2 years.
12. Pregnant or lactating females.
13. Known concomitant genetic or acquired immune suppression disease such as HIV.
14. Centrally located lung cancer, or evidence of solid tumor invading major blood vessels on imaging.
15. Malabsorption, uncontrolled vomiting or diarrhea, or any disease significantly affecting gastrointestinal function that could interfere with absorption of study drugs, or inability to swallow oral drugs.
Drugs and Treatments to be Excluded
* Chemotherapy, biological therapy (including cytokines, signal transduction inhibitors, monoclonal antibodies), immunotherapy or any other therapy for solid tumors.* Systemic hormonal therapy, with the exception of:
* Hormonal therapy for appetite stimulation or contraception
* Nasal, ophthalmic, inhaled and topical steroid preparations
* Androgen suppression therapy for non-metastatic prostate carcinoma
* Hormone replacement therapy for conditions such as adrenal insufficiency, hypothyroidism, diabetes, etc.
* Low-dose maintenance steroid therapy (equivalent of prednisone ≤ 10 mg/day) for other conditions* Treatment with radiotherapy (limited radiotherapy involving ≤ 25% of bone marrow may be allowed for palliative purposes after consultation with the medical monitor. Treatment with study drugs (tivozanib and capecitabine) must be stopped during radiotherapy).* Herbal preparations/supplements (including daily multivitamin/mineral supplement containing herbal components).* Treatment with full dose oral anticoagulants such as warfarin, acenocoumarol, fenprocoumon, or similar agents. If previously receiving these types of agents, a minimum washout of 1 week and documented INR of ≤ 1.5 will be required prior to start of therapy. Full dose anticoagulation with low molecular weight heparin or unfractionated heparin administered subcutaneously is allowed. Low dose oral anticoagulation (eg, 1-2 mg/day warfarin) is allowed provided INR remains ≤ 1.5 during the study. | 15,550 |
Study Objectives
The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase.
Conditions: Squamous Carcinoma, Head and Neck Cancer, Anal Cancer, Lung Cancer, Esophageal Cancer, Cervix Cancer
Intervention / Treatment:
| Inclusion Criteria:
* Morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (SCC) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung.* The patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy* The tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions* The patient must be at least 18 years of age, able to understand the given information and, leave a written informed consent to participate
Exclusion Criteria:
* The patient is unwilling to participate in the study* Patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour)* Pregnancy or lactation* Contraindications to investigations with MRI, gadolinium contrast or PET-tracers* Patients with an estimated glomerular filtration rate (GFR) <60 ml/min/1.73m2.* Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective. | 18,679 |
Study Objectives
Introduction: There are several manifestations in the oral mucosa resulting from antineoplastic treatments by chemo (QT) or radiotherapy (RT). In this study we will collect the variables referring to oral mucositis (OM), radiodermatitis, osteonecrosis of the jaws (ONJ), hyposalivation and xerostomia, dysgeusia, pain, oral candidiasis (opportunistic infection), trismus, quality of life, oral hygiene.
MO and hyposalivation, which are related to damage to the salivary glands, are the most common manifestations, and ONJ is the most difficult to treat. The dentist can play an important role in prevention and treatment these oral lesions, directly influencing the patient's quality of life and adherence to antineoplastic treatment.
Objectives: The main objective is to evaluate the efficacy of the intervention, using LLL phototherapy and topical Vit E, in the OM. And the intervention through LLL phototherapy and LPRP in the ONJ. These interventions will be performed by dentists during antineoplastic medical treatment.
Material and methods: clinical trial, randomized, with balanced randomization, single-blind (for the evaluator of the results) with 2 experimental arms and a control group, carried out in a single center. Group 1, intervention with LLL phototherapy, Group 2, intervention with application of topical Vit E and Group 3, mouthwash with 0.12% chlorhexidine (usual clinical information). 360 patients will participate in this study from the Units of Oncology Medicine, Radiotetaphic Medicine and Oral Medicine, Oral Surgery and Implantology at the University of Santiago de Compostela. The segment of the patients will be given, an initial visit and returns every day that hears the application of antineoplastic treatment for the group of LLL phototherapy, returns of 15 days, one month, three months, six months, nine months and one year. In these return visits, evaluations and questionnaires will be carried out regarding all the variables that we will collect.
Predictable results: If the application of laser phototherapy or topical Vit E contributes to the cessation, reduction or improvement of the clinical evolution of the manifestation of oral lesions, these treatments could be immediately implemented in our Oral Medicine unit and could lay the foundations for its implementation in different public centers and private.
Conditions: Oral Mucositis, Osteoradionecrosis, Osteonecroses, Bisphosphonate, Osteonecrosis Due to Drugs, Jaw, Hyposalivation, Head and Neck Cancer, Oral Cancer
Intervention / Treatment:
DEVICE: Preventive, LLL Phototherapy and topical Vit E, DEVICE: Curative, LLL Phototherapy and topical Vit E, DEVICE: Preventive, LLL Phototherapy and LPRF, DEVICE: Curative, LLL Phototherapy and LPRF
| Inclusion Criteria:
* Patients with head and neck or breast cancer who will undergo chemotherapy or radiotherapy.
Exclusion Criteria:
* Participants who do not sign the informed consent.
* Patients who have been or will be treated by chemo and radiotherapy together.
* Patients in treatment of a cancer recurrence.
* Patients reporting diabetes or sjogren's syndrome. | 18,175 |
Study Objectives
it is hypothesized that long term outcomes of localized resection of GIST tumors located in the second part of the duodenum are comparable to those of the traditional treatment by radical resection of the head o pancreas and the entire duodenum
Conditions: Gastrointestinal Stromal Tumor of Duodenum
Intervention / Treatment:
PROCEDURE: surgical resection
| Inclusion Criteria:
* patients with second part duodenal GIST
Exclusion Criteria:
* metastatic, irresectible and unfitness for surgery | 8,966 |
Study Objectives
The correlation between the change of serum prostate-specific antigen (PSA) or PSA velocity (PSAV) and severity of lower urinary tract symptoms (LUTS) has been poorly understood. Previous studies usually focused on the treatment efficacy or preventive role of alpha blockers (AB) for clinical progression of benign prostatic hyperplasia (BPH) and AB therapy in real-life practice improved BPH/LUTS and reduced the risk of overall clinical progression. We hypothesized that the change of PSA and PSA velocity would be correlated to LUTS severity in the groups of BPH and prostate cancer.
Conditions: Benign Prostatic Hyperplasia, Prostate Cancer
Intervention / Treatment:
OTHER: PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography
| Inclusion Criteria:
* more than two consecutive PSA measurements before the biopsy and the medication periods of AB more than 3 months in all patients
Exclusion Criteria:
* any prostate surgery during the study period, any prostate disease with evidence of prostatic inflammation, any urologic surgery before PSA measurement, and medication history of anticholinergics or 5-alpha reductase inhibitors | 31,571 |
Study Objectives
The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.
Conditions: Gastrointestinal Stromal Tumors
Intervention / Treatment:
DRUG: Nilotinib, OTHER: Best Supportive Care (BSC) +/- imatinib or sunitinib
| Inclusion criteria (Core Phase):
* Age ≥18 years
* Radiological confirmation of disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
* At least one measurable site of disease on CT/MRI scan
* Physically fit even if not able to work
* Normal organ, electrolyte, and bone marrow function
Inclusion criteria (Extension Phase):
* Patients whose tumors had progressed on the control arm and had crossed over to the nilotinib arm.
* The study was stopped due to meeting the primary efficacy endpoint of PFS at the interim analysis.
* Patients who were still being treated at the close of the Core study on the control arm or nilotinib arm (whose tumors have not progressed at the time of the end of the Core study).
* Patients must have had documented, confirmed stable, partial or complete response as defined by the RECIST criteria at the time of entry into the Extension study with the exception of patients who had progressed on the control arm.
Exclusion criteria (Core Phase):
* Previous treatment with nilotinib or any other drug in this class or other targeted therapy
* Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks prior to study entry
* Impaired cardiac function
* Use of coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
* Women who are pregnant or lactating
Exclusion criteria (Extension Phase):
* Use of other anticancer treatments or investigational drugs (with exception of the study drugs)
* Patients with a history of noncompliance with study drug treatment in the Core study protocol.
Other protocol-defined inclusion/exclusion criteria applied | 31,935 |
Study Objectives
The mortality induced by infections in onco-hematological patients is abnormally high at the acute phase of septic shock. Consequently, it is important to detect the population with a high risk of short term mortality among patients with a septic shock. The aim of this study is the evaluation of predictive proteic profile on the short term mortality in the acute phase of septic shock in cancer patients.
Conditions: Sepsis, Septic Shock, Cancer
Intervention / Treatment:
OTHER: SELDI-TOF MS for plasmatic proteic profile
| Inclusion Criteria:
* Patient from oncology or hematology with a septic shock
* Patient aged 18 years and older
* Inclusion within the 24 hours of the septic shock in the intensive care unit
* Signed consent according to the emergency reglementation
Exclusion Criteria:
* Pregnancy, breast feeding
* Patient with decision of care limitation
* Patient with legal protection | 22,055 |
Study Objectives
The Investigators in the PCRT team have developed a therapeutic regimen which attacks both the tumor compartment and the stromal compartment of pancreatic cancer and induces complete responses in a small percentage of patients with advanced stage IV pancreatic cancer.
Conditions: Stage IV Pancreatic Cancer
Intervention / Treatment:
DRUG: Gemcitabine, DRUG: nab-paclitaxel, DRUG: FOLFIRINOX, GENETIC: Immunohistochemistry (IHC) Analysis, DRUG: Metformin, DRUG: mFOLFIRI
| Inclusion Criteria:
* Histologically documented Stage IV metastatic adenocarcinoma of the pancreas with measurable disease
* Performance status ECOG 0 or 1
* Patients may not have received prior treatment for metastatic pancreatic adenocarcinoma except for receiving gemcitabine or 5FU as a radiosensitizer along with radiation therapy; or have received gemcitabine for adjuvant treatment if they have been off gemcitabine for > 12 months
* Adult (>18 years of age) male or non-pregnant and non-lactating female
* A negative serum pregnancy test (Beta-hCG) documented within 72 hours of the first administration of study drug in female patients of child-bearing potential
* Agreement to use contraception considered adequate and appropriate by the investigator
* The following blood counts at baseline:
* ANC >= 1.5 x 109/L
* Hgb > 9g/dL
* Platelets >100 x 109/L
* The following blood chemistry levels at baseline:
* AST and ALT <= 2.5 x upper limit of normal range (ULN) or < 5.0 ULN if liver metastasis are present
* Bilirubin <= ULN
* Serum creatinine within 1.5 x ULN
* PT, INR within 1.5 x ULN unless on therapeutic doses of warfarin
* Must have measurable disease outside the pancreas by RECIST criteria
* No clinically significant abnormalities in urinalysis results
* Voluntary agreement to participate in this study after being informed about the nature of the study including potential risks and benefits and having the ability to have questions addressed. The patient must sign and date the IRB approved Informed Consent Form (ICF) prior to participation in any study-related procedures
Exclusion Criteria:
* Has pancreatic islet cell neoplasms
* Is pregnant or lactating
* Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Known infection with HIV, Hepatitis B or Hepatitis C.
* Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies (see section 4.4.9)
* Has a serious medical risk factor(s) involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
* Is unwilling or unable to comply with study procedures.
* Is enrolled in any other investigational trial.
Caution of observation for interstitial pneumonitis in patients prior to enrollment:
Before enrollment, evaluate candidate patients fro familial, environmental or occupational exposure to opportunistic pathogens, and do not enroll those with a history of slowly progressive dyspnea and unproductive cough, or of conditions such as sarcoidosis, silicosis. idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies. | 21,506 |
Study Objectives
This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.
Conditions: Non-small-cell Lung Cancer
Intervention / Treatment:
DRUG: ARQ 197 and Erlotinib
| Inclusion Criteria:
* Voluntary written informed consent for study participation must be obtained
* A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
* History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
* ECOG PS of 0 or 1
* Life expectancy of ≥3 months
Exclusion Criteria:
* Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
* Surgery for cancer within 28 days prior to ARQ 197 dose
* Active double cancer
* Known symptomatic brain metastases
* An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
* Pregnant or lactating
* Subjects who wish to have a child and who would not agree to use contraceptive measures | 15,985 |
Study Objectives
A total of 60 female patients (30 patients in each group) with cutaneious warts diagnosed by a consultant dermatologist on physical examination were included in this study.
In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of \> 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
Conditions: Cutaneous Warts
Intervention / Treatment:
DRUG: liq nitrogen, DRUG: intralesional vitamin D3
| Inclusion Criteria:
* Patient of cutaneous warts presented in dermatology department.
Exclusion Criteria:
* Immunosuppressed patients
* chronic skin diseases like eczema or autoimmune disease
* diabetes mellitus
* cold sensitivity , skin allergies
* pregnancy, and lactation
* periungual warts | 18,665 |
Study Objectives
The purpose of this study is to determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with breast cancer
Conditions: Breast Cancer
Intervention / Treatment:
RADIATION: 6 Gy/ fraction
| Inclusion Criteria:
* Post-menopausal women (at least 2 years without menstrual period):
hysterectomized patients need follicle-stimulating hormone (FSH) confirmation of post-menopausal status.
* Original tumor non-palpable (mammographically detected).
* Small primary tumor (pT1) breast cancer, excised with negative margins (defined as at least a 5 mm margin).
* N0 or sentinel node negative or N0 clinically if the tumor is <1 cm in size.
* Patient offered six weeks of post-segmental mastectomy conventional radiation therapy and declined.
* Prescribed antihormonal therapy as part of their management.
Exclusion Criteria:
* Previous radiation therapy to the ipsilateral breast.
* Presence of a proportion of ductal carcinoma in situ (DCIS) in the pathology specimen which is compatible with extensive intraductal component (EIC).
* Women incapable of providing their own consent. Mental status will be assessed by the Principal Investigator using the Radiation Therapy Oncology Group (RTOG) Mini-Mental Status Examination.
* Women with a diagnosis of multifocal breast cancer. | 22,251 |
Study Objectives
In the management of patients with acute upper gastrointestinal bleeding from non-variceal causes, endoscopic treatment and acid suppression are now the standard of care. Current endoscopic treatment in the form of either thermo-coagulation or clipping to the bleeding arteries is highly efficacious in the stopping bleeding. Unfortunately in 5 to 10% of patients, bleeding cannot be controlled during index endoscopy or recurs after initial hemostasis. These patients are often elderly with significant co-morbidities. Their bleeding lesions are large eroding into major sub-serosal arteries. In the few who need surgical salvage, mortality increases to around 30%. The Over-the-scope-Clip (OTSC) is a device, which allows endoscopists to capture a large amount of tissue and compress on the bleeding artery. The OTSC also has a high retention rate. Recurrent bleeding with the use of standard hemo-clips can occur because of their low retention rate. We reported the use of OTSC with a high success rate in a case series of patients with refractory bleeding after standard endoscopic treatment. We have also used OTSC in the treatment of bleeding from pseudo-aneurysm arising from large eroded arteries in ulcer base. A multicenter randomized controlled trial that compares OTSC to standard endoscopic treatment in the endoscopic treatment of refractory bleeding lesions has just been completed. The use of OTSC has been shown to be superior in achieving hemostatic control and reducing further bleeding. In this proposed randomized controlled trial, we would test the hypothesis that the use of OTSC, when used as the first or primary treatment, is superior to standard treatment in achieving hemostasis and thereby improve patients' outcomes.
Conditions: Acute Upper Gastrointestinal Bleeding, Tumor Bleeding
Intervention / Treatment:
DEVICE: Over-the-scope Clips, DEVICE: Hemo-clipping, DEVICE: thermo-coagulation, DRUG: Epinephrine
| Inclusion Criteria:
* Patients with overt signs of acute upper GIB (melena, hematemesis, drop in hemoglobin with or without hypotension)
* documented bleeding lesions suitable for standard endoscopic treatment during endoscopy
Exclusion Criteria:
* without a full informed consent from the patient or his legally-acceptable representatives
* Age <18 years
* Pregnant
* Lactating women
* Moribund patients not considered for active treatment. | 11,060 |
Study Objectives
This study will evaluate the rate of pathological complete response (pCR) to the sequential therapy of Doxil, paclitaxel, and cyclophosphamide with concurrent Avastin for patients with locally advanced invasive (T2,T3, Nany, M0) breast carcinoma. Also, the study will evaluate the clinical and subclinical cardiotoxic effect(s) of this regimen, assess how feasible and safe the study is. Survival without any progression of disease will also be calculated.
A regimen of chemotherapy will be given to replicate the high rate of pCR seen with conventional chemotherapy in patients with locally advanced breast cancer. Doxil will substitute the normally given doxorubicin. It is expected that the low effect or minimal effect of Doxil on cardiac function will minimize any additional risk of cardiotoxicity from Avastin. It is expected that clinical and subclinical rates of cardiotoxicity will be very low at the total doses to be given in this clinical trial.
Conditions: Invasive Breast Cancer
Intervention / Treatment:
DRUG: Doxil, Paclitaxel, Cyclophosphamide, Avastin
| Inclusion Criteria:
* Histologically confirmed, measurable, invasive breast carcinoma T >2cm, Nany, M0.
* Patients with node-negative, ER or PR-positive tumors ≤4 cm in size whose tumors are low risk (defined as a score of 0-17) on an Oncotype DX profile are not eligible.
* 19 years of age or greater
* Known ER, PR and HER-2 status (FISH assay to be done on specimens with 2+ or 3+ immunohistochemical staining for HER-2): patients with gene amplification on FISH study will be considered to be HER-2 positive. Patients for this study must be FISH negative if immunohistochemical stain is 2+ or 3+ positive; patients with negative, 0 or 1+ immunohistochemical stain for HER-2 are eligible.
* Known axillary nodal status: aspiration cytology or biopsy
* Documented menopausal status premenopausal (having menstrual periods or FSH <35) or postmenopausal (≥12 months since last menstrual period with intact uterus and at least one ovary or FSH ≥35 or previous bilateral oophorectomy
* Non-pregnant if premenopausal (negative serum or urine pregnancy test within 7 days of starting chemotherapy) and not breast feeding
* Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.
* Life expectancy of less than 12 weeks
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
* Pregnant or lactating women.
* History of cardiac disease, with New York Heart Association Grade II or greater or clinical evidence of congestive heart failure.
* Serious comorbid medical conditions which would impair the ability to receive chemotherapy on time
* Previous invasive cancer within the last 5 years
* Altered mental status or dementia which would interfere with understanding of informed consent and ability to comply with study and follow-up procedures.
* Hypersensitivity to Doxil, doxorubicin, cyclophosphamide, cremophore (contained in teniposide, cyclosporine, and vitamin K), or to any component of Avastin
* Inadequately controlled hypertension (defined as blood pressure of >150/100 mmHg on antihypertensive medication)
* Unstable angina pectoris
* History of myocardial infarction or unstable angina within 12 months prior to beginning therapy
* History of stroke or TIA at any time
* Clinically significant vascular (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis, aortic dissection) or peripheral vascular disease with 6 months prior to beginning therapy
* History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to beginning therapy
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy or anticipation of need for major surgical procedure during the course of the study
* Patients must have a 2-d echocardiogram indicating an ejection fraction of > 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.
* No distant metastases on bone scan and on CT scans of chest and abdomen (no metastasis on optional PET scan is an acceptable alternative; if PET scan is done for any reason it must show no evidence of distant metastasis). Baseline PET scan is recommended but not required for all patients.
* No CNS metastasis
* Hbg ≥9 gm, platelets ≥100,000, granulocytes ≥1000, total or direct bilirubin ≤1.2, creatinine ≤2.0 and urine protein:creatinine ratio <1.0
* No prior chemotherapy or radiotherapy and ≤4 weeks of prior antiestrogen or aromatase inhibitor therapy
* No concomitant hormone replacement (i.e. estrogen or progestin) therapy
* PS less than or equal to one
Exclusion Criteria:
* Minor surgical procedure (excluding placement of a vascular access device) such as fine needle aspiration or core needle biopsy within 7 days of beginning therapy
* Urine protein:creatinine ratio ≥1.0 at initial screening
* Known hypersensitivity to any component of Avastin
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of beginning therapy
* Serious, non-healing wound, active ulcer, or untreated bone fracture
* Any prior history of hypertensive crisis or hypertensive encephalopathy
* Known CNS metastasis, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded. | 10,098 |
Study Objectives
Currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. This study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.
Conditions: Recurrent and Metastatic Endometrial Cancer
Intervention / Treatment:
DRUG: Letrozole
| Inclusion criteria
* Postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium
* No adjuvant therapy
* Up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed
* No chemotherapy for recurrence (adjuvant permitted)
* Unidimensionally measurable disease
* Good Health status 0-2 (Eastern Cooperatitve Oncology Group)
* No prior tamoxifen or aromatase inhibitor therapy
* No other concurrent anti-cancer treatment
* No metastases in the central nervous system
Exclusion criteria:
Additional protocol-defined inclusion/exclusion criteria may apply | 26,255 |
Study Objectives
Primary objective:
* To evaluate activity of imatinib mesylate and hydroxyurea among patients with progressive/recurrent grade II low-grade glioma (LGG) as measured by 12-month progression free survival
Secondary objectives:
* To evaluate progression-free survival (PFS), overall survival and objective response rate among patients with progressive/recurrent grade II LGG treated with imatinib mesylate plus hydroxyurea
* To assess safety and tolerability of imatinib mesylate + hydroxyurea in this population
Conditions: Glioblastoma, Gliosarcoma
Intervention / Treatment:
DRUG: Imatinib Mesylate & Hydroxyurea
| Inclusion Criteria:
* Patients with grade II LGG that is recurrent/progressive following prior surgical resection while on non-decreasing dose of corticosteroids
* > 25percent enlargement of bidimensional measure/new lesions on sequential imaging new \&/or worsening neurologic deficits
* Patients with progressive/recurrent optic pathway tumors
* Patients have measurable disease on MRI/CT
* Interval of > 4 wks between prior external beam radiation therapy (XRT)/chemo,\& enrollment on protocol unless there is unequivocal evidence of tumor progression \& patient has recovered from all expected toxicities associated with prior therapy. Patients treated w chemo agents such as VP-16 who would normally be retreated after shorter intervals may be treated at usual starting time even if < 4 wks from last prior dose of chemo
* Patients not have had tumor biopsy < 1 wk/surgical resection < 2 wks prior to starting study drug
* Patients enrolling on arm B must be on > 1 enzyme inducing anticonvulsants for >2 wks prior to starting study drug
* Patients should be on non-increasing dose of steroids for > 7 days prior to obtaining baseline Gd-MRI of brain
* Patients should be on non-increasing dose of steroids for > 7 days prior to starting study drug
* Multifocal disease is eligible
* Age > 18 yrs old
* Karnofsky Performance Status (KPS) of > 60
* absolute neutrophil count (ANC) > 1.5 x 10 9/L
* Hgb > 9 g/dL
* Platelets > 100 x 10 9/L
* K ≥ lower limit of normal (LLN)/correctable with supplements
* Ca ≥ LLN/correctable with supplements
* P ≥ LLN/correctable with supplements
* aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) \& Alanine transaminase (ALT)/ Serum Glutamic Pyruvate Transaminase (SGPT} < 2.5 x ULN
* Serum bilirubin < 1.5 x upper limit of normal (ULN)
* Serum creatinine < 1.5 x ULN/measured 24hr Creatinine Clearance > 50 mL/min/1.73m2
* Life expectancy ≥ 12wks
* Written informed consent obtained prior to screening procedures
Exclusion Criteria:
* Prior progressive disease/toxicity grade ≥ 3 with prior hydroxyurea therapy
* Prior treatment with imatinib/other platelet derived growth factor (PDGF)-directed therapy
* Excessive risk of bleeding as defined by stroke < 6 months, history of central nervous system (CNS)/intraocular bleed, or septic endocarditis
* Evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post-operative gr1 hemorrhage
* Pregnant/breast feeding, /adults of reproductive potential not employing effective method of birth control
* Concurrent severe and/or uncontrolled medical disease that could compromise participation in study
* Acute/chronic liver disease
* Confirmed diagnosis of HIV infection
* Impairment of GI function/GI disease that may significantly alter absorption of imatinib
* Patients taking Coumadin
* Patients have received investigational drugs < 2wks prior to entry on study/have not recovered from toxic effects of such therapy
* Patients have received biologic, immunotherapeutic/cytostatic agents < 1 wk prior to entry on study/have not recovered from toxic effects of such therapy
* Patient > 5 yrs free of another primary malignancy except: if other primary malignancy is not currently clinically significant/requiring active intervention, or if other primary malignancy is basal cell skin cancer/ cervical carcinoma in situ. Existence of any other malignant disease is not allowed
* Patients have had any surgery other than resection of brain tumor < 2 wks prior to entry on study/have not recovered from side effects of such therapy
* Patients unwilling to/unable to comply with protocol
* Active systemic bleeding, such as GI bleeding/gross hematuria
* Gr2 /> peripheral edema/central/systemic fluid collections
* Patients who enroll on arm A must have not received any EIAC for > 2 wks prior to starting study regimen
* Any of following exclusion criteria to MRI imaging:
* Cardiac pacemaker
* Ferromagnetic metal implants other than those approved as safe for use in magnetic resonance (MR) scanners
* Claustrophobia
* Obesity | 18,136 |
Study Objectives
This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Conditions: Childhood Extracranial Germ Cell Tumor, Childhood Extragonadal Malignant Germ Cell Tumor, Childhood Malignant Ovarian Germ Cell Tumor, Childhood Malignant Testicular Germ Cell Tumor, Ovarian Choriocarcinoma, Ovarian Embryonal Carcinoma, Ovarian Yolk Sac Tumor, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Ovarian Germ Cell Tumor, Testicular Choriocarcinoma, Testicular Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Yolk Sac Tumor, Testicular Mixed Embryonal Carcinoma and Yolk Sac Tumor, Testicular Yolk Sac Tumor
Intervention / Treatment:
DRUG: Carboplatin, BIOLOGICAL: Filgrastim, DRUG: Ifosfamide, OTHER: Laboratory Biomarker Analysis, DRUG: Paclitaxel
| Inclusion Criteria:
* Histologically confirmed (at original diagnosis) extracranial germ cell tumor (GCT) containing 1 of the following malignant elements:
* Yolk sac tumor (endodermal sinus tumor)
* Choriocarcinoma
* Embryonal carcinoma
* Meets 1 of the following disease criteria:
* Recurrent malignant disease
* Chemotherapy-resistant disease
* Relapsed disease
* Disease refractory to conventional therapy
* Measurable disease
* Must have received a prior first-line chemotherapy regimen that included cisplatin
* Patients with tumor marker (AFP and/or BHCG) elevation alone or bone scan findings alone are not eligible\*
* Patients with immature teratoma (any grade), germinoma, sex-cord stromal tumors, or recurrent GCT previously treated with surgery alone are not eligible
* Karnofsky performance status (PS) 50-100% (age > 16 years) OR Lansky PS 50-100% (age ≤ 16 years) OR ECOG PS 0-2
* Life expectancy ≥ 8 weeks
* Absolute neutrophil count ≥ 750/mm³
* Platelet count ≥ 75,000/mm³ (transfusion independent)
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal based on age/gender, as defined by the following:
* ≤ 0.4 mg/dL (1 month to < 6 months of age)
* ≤ 0.5 mg/dL (6 months to < 1 year of age)
* ≤ 0.6 mg/dL (1 to < 2 years of age)
* ≤ 0.8 mg/dL (2 to < 6 years of age)
* ≤ 1.0 mg/dL (6 to < 10 years of age)
* ≤ 1.2 mg/dL (10 to < 13 years of age)
* ≤ 1.4 mg/dL (13 to ≥ 16 years of age) (female)
* ≤ 1.5 mg/dL (13 to < 16 years of age) (male)
* ≤ 1.7 mg/dL (≥ 16 years of age) (male)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
* ALT < 2.5 times ULN for age
* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by gated radionuclide study
* No dyspnea at rest
* No exercise intolerance
* Pulse oximetry > 94% (if there is clinical indication for determination)
* Patients with seizure disorder are eligible provided they are on non-enzyme inducing anticonvulsants and seizures are well controlled
* No CNS toxicity > grade 2
* No active graft-versus-host disease
* No allergy to Cremophor EL or castor oil
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other concurrent chemotherapy or immunomodulating agents
* Recovered from prior chemotherapy, immunotherapy, or radiotherapy
* At least 1 week since prior growth factors (2 weeks for pegfilgrastim)
* At least 1 week since prior biologic therapy
* At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea)
* At least 2 weeks since prior local palliative radiotherapy (i.e., small port)
* At least 6 months since prior craniospinal radiotherapy or radiotherapy to ≥ 50% of pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
* At least 6 months since prior allogeneic stem cell transplantation
* Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated | 37,085 |
Study Objectives
The purpose of this study is to validate a pre-defined single-patient classifier algorithm for predicting prognosis and benefit from adjuvant chemotherapy for patients who underwent D2 gastrectomy for stage II and III gastric cancer. This algorithm classifies gastric cancer into five groups according to its molecular characteristics based on RNA expression levels. The prognosis and response from adjuvant chemotherapy will be different according to prognostic and predictive clusters respectively based on these groups, thus this algorithm can identify as patients which will have benefit from adjuvant chemotherapy or which will not. Consequently, this algorithm can be translated into clinical practice to help doctors who decide the necessity of adjuvant chemotherapy after D2 gastrectomy for patients who had diagnosed stage II and III gastric cancer.
Conditions: Stage II-III Gastric Cancer
Intervention / Treatment:
GENETIC: nProfiler I Stomach Cancer Assay Kit
| Inclusion Criteria:
* aged 18 years or older
* histologically confirmed, American Joint Committee on Cancer/Union Internationale Contre le Cancer (6th edition) 2 stage II (T2N1, T1N2, T3N0), IIIA (T3N1, T2N2, T4N0), or IIIB (T3N2) gastric adenocarcinoma with no evidence of metastatic disease
* previous D2 surgery with achieved R0 resection
* Karnofsky performance status of >70%
* adequate renal function (creatinine clearance >50 mL/min or serum creatinine ≤1·5 times the upper limit of normal), hepatic function (total bilirubin ≤1·5 times the upper limit of normal, aspartate or alanine aminotransferase ≤2·5 times the upper limit of normal), and hematological function (absolute neutrophil count ≥1·5 × 109/L or platelet count ≥100 × 109/L)
* adequate hepatic function
* formalin-fixed paraffin-embedded (FFPE) tumor blocks, pathologic reports, and clinical information were all available.
Exclusion Criteria:
* chemotherapy, immunotherapy, or radiotherapy for GC prior to surgery
* no available FFPE tumor blocks
* insufficient RNA quality to be analyzed. | 27,465 |
Study Objectives
The purpose of this study is to examine the impact of a lifestyle intervention. The study will examine the Stay on Track program, dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy.
Conditions: Breast Cancer
Intervention / Treatment:
BEHAVIORAL: Lifestyle- Supportive Care
| Inclusion Criteria:
* > 18 years of age;* confirmed primary non-metastatic breast adenocarcinoma;* planned lumpectomy/segmentectomy/partial mastectomy surgery for primary breast cancer;* planning to undergo adjuvant whole breast radiation therapy following a lumpectomy;* Have a Karnovsky Performance Score of 70 or above (see Appendix)* Patient's Body Mass Index (BMI) is greater than determine by the treating physician, not currently meeting physical activity guidelines: moderate physical activity for at least 30 minutes at least five days a week AND 2 weekly sessions of resistance exercise;* have access to a mobile phone with capacity for text messaging (either unlimited or aware and accepting of text messaging charges);* understand and speak English;* physically able to engage in the intervention;* accepting of randomization (Note that anti-estrogen therapy is allowed.)
Exclusion Criteria:
* Patients who have metastatic disease;* Patients with a history of prior malignancy within the past 3 years, other than non-melanoma skin cancer.* Patients with serious orthopedic, cardiovascular, or pulmonary conditions, have serious psychiatric or cognitive problems.* Patients who have received chemotherapy for their breast cancer.* Patients with prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields. | 26,314 |
Study Objectives
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer.
Conditions: Lung Cancer, Metastatic Cancer
Intervention / Treatment:
DRUG: Temozolomide, RADIATION: Radiation therapy
| Inclusion Criteria:
* Histologically confirmed non-small cell lung cancer (NSCLC), including the following histologies:
* Squamous cell carcinoma
* Adenocarcinoma
* Large cell carcinoma
* Bronchoalveolar carcinoma
* All variants of NSCLC
* At least 1 bidimensionally measurable brain metastasis
* Confirmed by MRI within the past two weeks, and computed tomography (CT) scan is not acceptable
* Biopsy is not required
* Not eligible for surgical resection or radiosurgery of brain metastasis
* Systemic disease not in immediate need of chemotherapy
* Age>=18 years
* ECOG Performance status of 0-1
* More than 12 weeks of life expectancy
* Adequate hematologic, renal, and liver function as demonstrated by laboratory values performed within two weeks, inclusive, prior to administration of study drug or registration
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (5 times ULN if liver metastases are present)
* Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases are present)
* Creatinine ≤ 1.6 mg/dL
* Fertile patients must use effective contraception
* Prior biologic therapy allowed
* More than 4 weeks since prior chemotherapy
* Prior radiotherapy for local control or palliative therapy for painful bony lesions allowed
* Prior surgery for brain metastasis allowed
* At least 4 weeks since prior radiotherapy to ≥ 15% of bone marrow (2 weeks for < 15% of bone marrow) and recovered
* No prior radiotherapy to ≥ 50% of bone marrow
* Concurrent radiotherapy to painful bony lesions allowed provided no more than 15% of bone marrow is irradiated
Exclusion Criteria:
* HIV positive
* AIDS-related illness
* Poor medical risks due to active nonmalignant systemic disease
* Frequent vomiting
* There is medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
* Pregnant or nursing
* Prior temozolomide
* Prior radiotherapy to the brain, including stereotactic radiosurgery to a different lesion
* Concurrent intensity modulated radiotherapy or 3-D cranial radiotherapy
* Other concurrent investigational agents
* Other concurrent treatment for brain metastasis
* Other concurrent chemotherapy during study radiotherapy
* Concurrent growth factors to induce elevations in blood counts for the purposes of administration of study drug at scheduled dosing interval or to allow treatment with study drug at a higher dose | 9,861 |
Study Objectives
To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy patients compared with symptom management performed by the primary gynecologic oncologist.
Conditions: Uterine Cervical Neoplasms, Ovarian Neoplasms, Gynecologic Neoplasms, Fallopian Tube Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Peritoneal Neoplasms
Intervention / Treatment:
BEHAVIORAL: Specialized Symptom Management and Supportive Care
| Inclusion Criteria:
* Female
* 18 years of age or older
* Diagnosis of Stage III, IV, or recurrent gynecologic malignancy (Uterine, Ovarian, Cervical, Vulvar, Vaginal, Fallopian Tube, Primary Peritoneal)
* Receiving active intravenous, intraperitoneal, or oral chemotherapy
* Patient at University of Michigan Gynecologic Oncology Clinic
Exclusion Criteria:
* Male
* Less than 18 years of age
* Patients without a diagnosis of a gynecologic malignancy
* Patients not receiving intravenous, intraperitoneal or oral chemotherapy at the time of enrollment
* Patients receiving radiation therapy with chemo-sensitization. | 27,546 |
Study Objectives
Pain, in neoplastic disease, is a symptom with severe negative impact on the quality of life of patients and a high incidence, with values around 70-90% in advanced and metastatic stages. Than 20 years the main reference for the pharmacological treatment of cancer pain are the guidelines produced by the World Health Organization (WHO). This document shows that the use of opioid drugs is the mainstay of treatment, with particular reference to opioids "major" (3 rd step of the analgesic ladder). The 4 opioids more most commonly prescribed in Italy (oral morphine and oxycodone, fentanyl and buprenorphine transdermal), based on the data currently available, have an analgesic effect would partly overlap but with different percentages of non-responders (NR), a different need to increase the dose over time to maintain adequate analgesia, a different action to the switch to another molecule for ineffectiveness analgesic. The observations described suggest that opioids, although they belong to the same family drug may not be fully comparable with regard to the clinical effects products. Important differences are known on the pharmacokinetic and pharmacodynamic and, more recently, also in terms of pharmacogenomics. This is a comparative study of analgesic strategies based on the use of the 4 mentioned opioids, going to look for possible differences in terms of analgesic efficacy, changes in dose over time, use of switch or permanent abandonment of treatment, parallel to the contour of the side effects. The associated sub-project will link the structure gene of patients and clinical results have emerged.
Conditions: Cancer, Cancer Pain
Intervention / Treatment:
DRUG: Morphine, DRUG: Fentanyl, DRUG: Buprenorphine, DRUG: Oxycodone
| Inclusion Criteria:
* patients with diagnostic (histological or cytological) evidence of locally advanced or metastatic solid tumour;
* with average pain intensity ≥ 4, measured with NRS and related to the last 24 hours, due to the cancer, requiring for the first time an analgesic treatment with 3rd step/WHO opioids
* with life expectancy > one month
* "strong" opioid naïve;
* eligible to take any of the medications under evaluation, by TDS or by mouth;
* with age ≥ 18 years;
Exclusion Criteria:
* Patients recruited in other researches that conflict or may confound the conduction and results of the present study;
* Lack of informed consent;
* with presence of other diseases, including psychiatric/mental illness, severe senile or other form of dementia, that can interfere with participation and compliance with the study protocol or can contraindicate the use of the investigational drugs;
* with presence of co-morbidities, which could create potentially dangerous drug interactions with opioids (eg, use of macrolide antibiotics or antifungal,....);
* any kind of contraindications to the use of opioid drugs;
* Patients with a known story, past or current, of drugs abuse or addiction;
* Use of drugs which presents a combination of opioids and other molecule (as NSAIDs, paracetamol, naloxone, ..);
* Patients who cannot guarantee regular follow-up visits for logistic or geographic reasons;
* Need of starting 3rd step treatment in an "emergency clinical situation" that do not allow the correct procedures of randomization;
* diagnosis of primary brain tumor or leukaemia;
* diagnosis of chronic renal failure;
* patients with antalgic radiotherapy or radio-metabolic therapy in progress or completed less than 14 days before study;
* patients starting a first line chemotherapy simultaneously to the beginning of the study;
* other types of analgesic treatments, including local-regional anesthetic techniques or neurosurgical /ablative methods. | 33,112 |
Study Objectives
AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.
Conditions: Neoplasm Metastasis
Intervention / Treatment:
DRUG: imexon
| Inclusion Criteria:
* Previously treated malignant disease of any type.
* Prior treatment; at least one prior regimen required.
* Able to perform the activities of daily living.
* Off prior cancer therapy for at least 4 weeks.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No other current drug therapy for the cancer.
* Blood counts and blood chemistries in or near normal range.
* Prior radiation is permitted.
Exclusion Criteria:
* No active brain metastases. | 4,728 |
Study Objectives
More than 5 years ago the DVT FREE Registry was conceived. Its database consists of 5,451 ultrasound-confirmed DVT patients from 183 institutions. This database is rich in information of critical importance to health care providers. The information contained within the database will be revisited to provide more detailed analyses which will be used for risk factor assessment and for decision-making regarding the implementation of VTE Prophylaxis.
Conditions: Venous Thromboembolism, Pulmonary Embolism, Cancer, Deep Vein Thrombosis, COPD
Intervention / Treatment:
| Inclusion Criteria:
* Ultrasound-confirmed DVT patients from 183 institutions. | 27,088 |
Study Objectives
The aim of the study is to determine the effect and safety of topical rapamycin or calcitriol and their combination for the treatment of TSC-associated facial angiofibroma.
Methods: A total of 52 TSC patients including 20 male and 32 female subjects were recruited, and 50 of them completed the period 1 study. In period 1, topical rapamycin (0.1%) or calcitriol (3 mcg/g) single-agent therapy versus their combination were applied twice a day by a left-right randomized, split-face comparison for 12 weeks. The primary end point was the reduction of facial angiofibroma severity index (FASI) for the grade of erythema, papule size, elevation and extension of the lesions at week 12. In period 2, the patients entered an open-label study and were reassigned to use the more effective ointment on both cheeks for another 12 weeks (week 13-24). A follow-up FASI analysis for recurrence after drug discontinuance for 12 weeks was also performed (week 36). The secondary end point was the reduction of Visual Analysis Score (VAS) evaluated by the subjects themselves at week 12.
Conditions: Facial Angiofibroma
Intervention / Treatment:
DRUG: Rapamycin, DRUG: Calcitriol, DRUG: Rapamycin-calcitriol combination
| Inclusion Criteria:
* Subjects must have been diagnosed or highly suspected as having TSC.* Subjects must be aged 7 to 70 years at Screening, and can be either sex.* Subjects must have symmetric facial angiofibromas.
Exclusion Criteria:
* Pregnancy or with a plan to be pregnant.* Subjects who cannot comply the treatment protocol.* Subjects with kidney or liver/ biliary dysfunction.* Subjects with hypercalcaemia and patients known to suffer from abnormal calcium metabolism.* Subjects on systemic treatment of calcium deficiency.* Subjects known to be hypersensitive to rapamycin or calcitriol. | 33,146 |
Study Objectives
The purpose of this study is to determine the safety and tolerability of intravenous administration of a tetravalent RNA-lipoplex cancer vaccine targeting four tumor-associated antigens in patients with advanced melanoma.
Conditions: Melanoma
Intervention / Treatment:
BIOLOGICAL: Lipo-MERIT
| Inclusion Criteria:
* Cohort I: stage IV malignant melanoma (American joint committee on cancer (AJCC) 2009 melanoma classification)
* Cohorts II-VII and expanded cohorts: stage IIIB-C, or stage IV of malignant melanoma (AJCC 2009 melanoma classification) \[only applicable until approval of protocol version 10.0\] Expanded cohort C only patients with stage IV melanoma (AJCC 2009 melanoma classification) with measurable disease (at least one target lesion according irRECIST) \[applicable for all patients included after approval of protocol version 10.0 and higher\] and with disease progression at the time of first treatment with Investigational medicinal product (IMP) \[applicable for all patients included after approval of protocol version 11.0\]
* Therapy only for subjects not eligible or declining any other available approved therapy after all available treatment options have been transparently disclosed (to be documented!)
* Expression of either NY-ESO-1, tyrosinase, MAGE-A3, and/or TPTE confirmed by RT-qPCR analysis from formalin-fixed paraffin-embedded (FFPE)
* ≥ 18 years of age
* Written informed consent
* Eastern cooperative oncology group (ECOG) performance status (PS) 0-1
* Life expectancy ≥ 6 months
* White blood cell (WBC) ≥ 3x10\^9/L
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 100,000/mm\^3
* Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) < 3 x upper limit of normal (ULN) (except patients with liver metastasis)
* Negative pregnancy test (measured by Human chorionic gonadotropin \[β-HCG\]) for females with childbearing age
Exclusion Criteria:
* Pregnancy or breastfeeding
* Primary ocular melanoma
* Concurrence of a second malignancy other than squamous or basal cell carcinoma, non-active prostate cancer, or cervical carcinoma in situ or non-active treated urothelial carcinoma
* Brain metastases
* Patients with history of treated or inactive brain metastasis are eligible for treatment in expanded cohort C, provided they meet all of the following criteria:
* measurable disease outside of the brain (in addition to inactive brain metastasis);
* no ongoing requirement of corticosteroids as therapy for brain metastases,
* with corticosteroids discontinued ≥1 week prior to visit 2 (day 1) with no ongoing symptoms attributable to brain metastasis;
* the screening brain radiographic imaging is ≥ 4 weeks since completion of radiotherapy
* Post-splenectomy Patients
* Known hypersensitivity to the active substance or to any of the excipients
* A serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) which requires systemic antibiotic treatment within 2 weeks prior to the first dose of study medication
* Positive test for acute or chronic active hepatitis B or C infection
* Clinically relevant active autoimmune disease
* Systemic immune suppression:
* Human immunodeficiency virus (HIV) disease
* Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
* Other clinical relevant systemic immune suppression
* Symptomatic congestive heart failure (NYHA 3 or 4)
* Unstable angina pectoris
* Radiotherapy and minor surgery within 14 days prior to the first study treatment administration
* Myelosuppressive chemotherapy within 14 days and after reconstitution of blood values prior to the first study treatment administration
* Ipilimumab within 28 days prior to the first study treatment administration
* Treatments with BRAF inhibitors, MEK inhibitors, or the combination of both, and anti-programmed death-1 (PD-1) antibodies within 14 days prior to the first administration of study treatment (not applicable for patients with parallel treatment in expanded cohorts A, B, or C at the discretion of the investigator)
* Interferon, major surgery, vaccination, and other investigational agents within 28 days or 5 half-lives depending on what gives the longer range before the first treatment
* Approved BRAF inhibitors vemurafenib or dabrafenib, approved anti-PD-1 inhibitors nivolumab or pembrolizumab as well as approved MEK inhibitor trametinib, or the approved combination of BRAF-MEK inhibitors in patients in dose escalation cohorts. Concomitant treatment with approved BRAF inhibitors, approved anti-PD-1 antibodies or MEK inhibitor as well as the approved combination of BRAF-MEK inhibitors is allowed for patients included in the expanded cohorts, after analysis of safety data collected for the dose escalation cohorts and data and safety monitoring board (DSMB) approval. Local radiation will be allowed as concurrent treatment for patients in expanded cohort as well.
- After approval of protocol version 10.0 and higher only anti-PD-1 antibodies are allowed for treatment of patients in expanded cohort C.
* Fertile males and females who are unwilling to use a highly effective method of birth control (less than 1% per year, e.g. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches or intrauterine device) during study treatment and for at least 28 days (male patients) and 90 days (female patients of childbearing potential) after the last dose of study treatment
* Presence of a severe concurrent illness or other condition (e.g. psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol | 21,122 |
Study Objectives
The overall goal of this project is to test two strategies for implementing a shared decision making tool to be used by providers while talking to patients about lung cancer screening. Eight participating sites will be randomized to compare standard implementation with intensive implementation. Additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will survey patients to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.
Conditions: Prevention and Control
Intervention / Treatment:
OTHER: Webinar, Promotion, and Tool Access, OTHER: LEAP, OTHER: Audit and Feedback, OTHER: Academic Detailing
| Inclusion Criteria:
* Patients at participating sites without documented exclusions for lung cancer screening who have had initial lung cancer screening clinical reminders resolved during the recruitment period
Exclusion Criteria:
Exclusions for initial lung cancer screening clinical reminders:
* history of lung, pancreatic, liver or esophageal cancer
* a health factor on file indicating they have a life expectancy of less than 6 months or who already had a chest CT in the past 12 months | 13,687 |
Study Objectives
Enzastaurin given daily to patients with non-small cell lung cancer who have failed at least one prior therapy.
Conditions: Non-Small-Cell Lung Carcinoma
Intervention / Treatment:
DRUG: Enzastaurin HCL
| Inclusion Criteria:
* Must be at least 18 years old
* Must have been diagnosed with advanced or metastatic non-small cell lung cancer
* Must be able to visit the doctor's office every 28 days for 6 months or longer.
Exclusion Criteria:
* Pregnant or breastfeeding women
* Have other significant medical problems as determined by your physician
* Are unable to swallow tablets
* Have a history of significant heart disease | 4,534 |
Study Objectives
This study is designed to assess the effects of adding nitroglycerin (NTG) patches, delivery 25 mg NTG per 24 h, to the standard first line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC), i.e. 4 cycles of carboplatin-paclitaxel-bevacizumab, followed by bevacizumab alone until disease progression. Tumor hypoxia is a common phenomenon in lung cancer; it is a known poor prognostic marker, related to treatment resistance. Pre-clinical studies have shown that nitric oxide (NO) donating drugs may decrease hypoxia related drug resistance. NTG is a NO donating drug. NTG increases tumor blood flow and thereby augments antitumor drug delivery to the tumor.
A randomized phase II has shown an increase in the response rate from 42% to 72%, when NTG patches (25 mg/day, day -2 to +3) were added to vinorelbine/cisplatin in patients with advanced NSCLC. In addition, the time to progression increased from 185 to 327 days.
The hypothesis of the present study is that adding NTG transdermal patches to bevacizumab containing chemotherapy improves progression free survival, response rate and overall survival in patients with metastatic non-squamous NSCLC.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: carboplatin paclitaxel bevacizumab, DRUG: Standard treatment plus nitroglycerin
| Inclusion Criteria:
* Histologically/cytologically proven stage IV non-squamous NSCLC (according to IASLC staging 7.0)
* No prior chemotherapy or therapy with systemic anti-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the HER axis (e.g. epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKI), Herceptin). Prior surgery and/or localized palliative irradiation is permitted provided that the irradiated lesion is not the only measurable lesion. Prior adjuvant chemotherapy > 1 year ago and prior treatment with an EGFR-TKI for patients with an activating EGFR mutation is allowed.
* Age ≥ 18 years.
* ECOG Performance Status of 0 - 2.
* Life expectancy of at least 12 weeks.
* Subjects with at least one uni-dimensional(for RECIST) measurable lesion.
* Adequate bone marrow, liver and renal function.
* Adequate non-hormonal contraception for females of childbearing potential during the study and in the 6 months thereafter.
* Adequate contraception for male participants (or their partners) during the study and in the 6 months thereafter.
Exclusion Criteria:
* Clinically significant (i.e. active) cardiovascular disease: congestive heart failure >NYHA class 2; CVA or myocardial infarction < 6 months prior to study entry; uncontrolled hypertension (blood pressure systolic > 150 mmHg and/or diastolic > 100 mmHg).
* Symptomatic hypotension.
* History of hemoptysis at least grade 2 (bright red blood of at least 2,5 ml in the last 3 months)
* Evidence of tumor invading major blood vessels on imaging (i.e. superior vena cava or pulmonary artery).
* History of HIV infection or chronic hepatitis B or C.
* Active clinically serious infection
* Symptomatic metastatic brain or meningeal tumors. Patients with brain metastasis may be included the patient is treated with brain radiotherapy and asymptomatic.
* History of organ allograft.
* Patients with evidence or history of bleeding diathesis.
* Non-healing wound or ulcer.
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
* Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
* Radiotherapy within 4 weeks of start of study drug. Palliative radiotherapy for bone lesions is allowed > 14 days of start of chemotherapy. Major surgery within 4 weeks of start of study.
* Use of vasodilators (including 5-phosphodiesterase inhibitors, calcium antagonists or nitrates)
* Autologous bone marrow transplant or stem cell rescue within 4 months of study
* Investigational drug therapy outside of this trial during or within 4 weeks of study entry
* Pregnancy or lactation. | 28,522 |
Study Objectives
Aromatase inhibitor medications have been approved by the U.S Food and Drug Administration (FDA) for treatment of hormone receptor positive breast cancer. This treatment has been shown to be very effective for treating breast cancer. However, some patients have difficulty tolerating the treatment, and some even decide to stop treatment because of the side effects. Research has shown that over half of patients who had joint pain and stiffness when taking an aromatase inhibitor had an improvement in their symptoms when they took omega-3 fatty acid supplements. This study is being conducted to test whether having patients start to take an omega-3 fatty acid supplement soon after they starting taking an aromatase inhibitor medicine will reduce the likelihood that they will have bothersome symptoms.
Conditions: Breast Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: Omega-3 fatty acid supplement
| Inclusion Criteria
* Female subject aged ≥ 18 years who are postmenopausal according to standard clinical criteria or who will have been receiving LHRH agonist therapy for at least 28 days prior to AI initiation.
* Stage 0-3 estrogen receptor positive (≥1%) and/or progesterone receptor positive (≥1%) breast cancer, or patients at high risk of developing breast cancer who are planning to initiate AI therapy for chemoprevention.
* Planned initiation of aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant treatment of breast cancer or for chemoprevention up to 30 days following baseline visit (ok to initiate screening up to 2 months before planned baseline visit). Concurrent LHRH agonist, anti-HER2 directed therapy (e.g., trastuzumab, pertuzumab, ado-trastuzumab emtansine), and/or CDK4/6 inhibitor therapy (e.g., palbociclib, ribociclib, abemaciclib) is permitted. Prior tamoxifen and/or toremifene is permitted.
* Completion of surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer. Completion of axillary surgery as indicated (not required). For patients at high risk of breast cancer who have not been diagnosed with breast cancer, no surgery is required.
* Completion of chemotherapy, if indicated. Concurrent use of radiation therapy, LHRHa therapy, anti-HER2 therapy, PARP inhibitor, and CDK4/6 inhibitor therapy is permitted. Prior tamoxifen is permitted.
* Agree to avoid taking omega-3 fatty acid supplements from sources outside the trial during study participation.
* ECOG Performance Status ≤ 3.
* Able to complete questionnaires in English.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria
* Prior use of AI therapy for treatment or prevention of breast cancer.
* Use of omega-3 fatty acid supplementation during the 3 months prior to enrollment. Consumption of O3-FA through diet is permitted.
* Use of warfarin, enoxaparin, or direct oral anticoagulants within 7 days prior to registration.
* Known chronic liver disease (laboratory studies will not be assessed). Patients with hepatosteatosis, viral hepatitis, or other liver disorders who have adequate liver function according to the treating physician are permitted to enroll.
* Known symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation (EKGs will not be performed).
* History of pancreatitis.
* Hypersensitivity to fish and/or shellfish.
* Unable to take oral medications.
* Any medical condition that would interfere with the absorption of study medication capsules.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not, in the opinion of the treating investigator, have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. | 26,758 |
Study Objectives
Evaluation weather early chemotherapy attempts for remission induction can improve the results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
| Inclusion Criteria:
* Patients with newly diagnosed AML (except acute promyelocytic leukemia) according to the WHO classification including patients with secondary AML and AML after preceding hematologic disorders
* Age 18 years or older
* Informed consent. Before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study.
Exclusion Criteria:
* Acute promyelocytic leukemia (APL)
* Previous or concurrent malignancies other than AML
* Previous treatment with colony-stimulating factors, interleukins or interferons
* Known hypersensitivity to Escherichia coli derived products (e.g. Filgrastim, HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®)
* Antibody-based or cell-based immunotherapies
* Respiratory insufficiency with pO2 <60 mmHg
* Heart failure NYHA III° or IV°
* Elevated creatinine >2.0 mg/dl
* Elevated bilirubin >2.0 mg/dl
* Pregnancy or lactation
* Females without adequate contraception
* Known HIV and/or hepatitis C infection
* Severe neurologic or psychiatric disease
* Psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for participation in this study
* Concerns for subject's compliance with the protocol procedures
* Lack of willingness to record and circulate personal disease-related informations defined in the study protocol | 38,253 |
Study Objectives
Our study is a case report of one of the rarest risk factor, Peutz-Jeghers syndrome, of small bowel malignancy detected in a patient with poorly differentiated adenocarcinoma of small bowel(jejunum)
Conditions: Peutz-Jeghers Syndrome
Intervention / Treatment:
| Inclusion Criteria:
* not necessary
Exclusion Criteria:
* not necessary | 26,186 |
Study Objectives
Phase I, open label, dual centre, dose finding study to evaluate the safety and tolerability of continuous twice daily oral dosing with AZD2281 when administered in combination with Bevacizumab 10mg/kg given every 2 weeks to patients with advanced solid tumours.
Conditions: Neoplasm Metastasis
Intervention / Treatment:
DRUG: AZD2281, DRUG: Bevacizumab
| Inclusion Criteria:
* Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
* Adequate bone marrow, kidney and liver function in accordance with laboratory parameters set out in the protocol
* Estimated life expectancy of at least 12 weeks
Exclusion Criteria:
* Disorders that may put the patient at risk of bleeding, including gastrointestinal perforation, intra-abdominal abcess, major surgery of the chest or abdomen, previous haemorrhage, coughing up blood or thrombotic event
* Hypertension (high blood pressure) or significant cardiovascular disease
* Hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanised antibodies | 12,341 |
Study Objectives
Because MRI can provide increased brain and liver lesion detection as compared with CT, the investigators hypothesize that FDG-PET/MRI will provide concordant or improved lesion detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation dose.
Conditions: Breast Cancer
Intervention / Treatment:
PROCEDURE: PET/MRI
| Inclusion Criteria:
Any patient with a history or breast cancer undergoing PET/CT either for initial staging or for disease surveillance
*
Exclusion Criteria:
* Pregnant patients and patients with known contraindications for whole body MR imaging (e.g., pacemakers, recent surgery, brain vascular clips, etc.) will be excluded from the study. Patients will be screened with a questionnaire to be sure they have no medical devices that could make the procedure unsafe. Patients with glomerular filtration rate (GFR) < 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study. | 8,113 |
Study Objectives
The primary purpose of this study is to evaluate the use of a digital information and communication platform (DICP) in improving outcomes in patients with cancer and their caregivers.
Conditions: Cancer
Intervention / Treatment:
OTHER: CancerLife
| Inclusion Criteria:
* Age > 18 years
* Diagnosis of cancer
* Receiving systemic treatment (chemotherapy, biotherapy/immunotherapy, hormonal therapy) that is expected to continue for at least 3 treatment sessions (approximately 9 weeks) from the time of enrollment
* Karnofsky Index ≥50%
* Able to understand and sign informed consent
* Owns and able to use an electronic communication device (smart phone, tablet, laptop, desktop) and answer simple self-report questionnaires on their own
Exclusion Criteria:
* Relevant cognitive impairment
* Participating in a therapeutic clinical trial
* Unable to read and comprehend English language text | 37,174 |
Study Objectives
Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
DRUG: Trastuzumab emtansine [Kadcyla]
| Inclusion Criteria:
* Signed study-specific Informed Consent Form(s)
* Age ≥ 18 years
* Histologically documented breast cancer
* HER2-positive disease
* Metastatic breast cancer
* Disease progression on the last chemotherapy regimen received in the metastatic setting
* Prior treatment with an anthracycline, trastuzumab, a taxane, lapatinib, and capecitabine in the neoadjuvant, adjuvant, locally advanced, or metastatic setting and prior treatment with at least two lines of therapy (a line of therapy can be a combination of two agents or single-agent chemotherapy) in the metastatic setting
* At least two lines of anti-HER2 therapy must have been given in the metastatic setting as monotherapy or combined with chemotherapy or hormonal therapy. The HER2-targeted agent can include trastuzumab, lapatinib, or an investigational agent with HER2-inhibitory activity.
* A minimum of 6 weeks of trastuzumab for the treatment of metastatic disease is required
* Patients must have had at least 14 days of exposure in the metastatic setting to lapatinib and capecitabine (given together or separately) unless they were intolerant of lapatinib and/or capecitabine
Exclusion Criteria:
* Chemotherapy ≤ 21 days before enrollment
* Trastuzumab ≤ 21 days before enrollment
* Hormone therapy ≤ 7 days before enrollment
* Granulocyte-stimulating agent < 14 days before enrollment
* Investigational therapy ≤ 28 days before enrollment
* Previous radiotherapy for treatment of metastatic breast cancer ≤ 21 days before enrollment
* Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastases within 3 months of the first study treatment
* History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins
* History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m\^2; Epirubicin > 900 mg/m\^2; Mitoxantrone > 120 mg/m\^2 and idarubicin > 90 mg/m\^2
* Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
* History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
* Current unstable angina
* History of symptomatic congestive heart failure (CHF), or ventricular arrhythmia requiring treatment
* History of myocardial infarction within 6 months of enrollment
* Left ventricular ejection fraction (LVEF) < 50% within 28 days of enrollment
* History of decreased LVEF to < 50% or symptomatic CHF with previous adjuvant trastuzumab treatment
* Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
* Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
* Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment
* Current pregnancy or lactation
* Current known infection with human immunodeficiency virus (HIV), active hepatitis B, and/or hepatitis C virus
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol | 36,017 |
Study Objectives
The aim of this study is to investigate the activity of Folfiri as Third line of treatment in mGC progressed after ramuciramb-based second line.
Conditions: Gastric Cancer, Ramucirumab, Third Line
Intervention / Treatment:
| Inclusion Criteria:
* Patients with histologically confirmed, ramucirumab pretreated metastatic gastric cancer who received
* Eastern Cooperative Oncology Group performance status ≤2 (ECOG PS)
* aged > 18 years
* neutrophil count ≥1500/μl
* platelet count ≥100 000/μl),
* renal (serum creatinine ≤1.5 mg/dl)
* liver (serum bilirubin ≤2 mg/dL) functions
* normal cardiac function,
* absence of second primary tumor other than non-melanoma skin cancer
* no concurrent uncontrolled medical illness.
Exclusion Criteria:
* Eastern Cooperative Oncology Group performance status >2 (ECOG PS)
* No prior treatment with ramucirumab
* operable metastatic disease were excluded from the study
* severe cardiac dysfunction, congestive heart failure or a recent myocardial infarction
* uncontrolled sites of infection. | 8,421 |
Study Objectives
Objective: To compare 2-dimensional and 3-dimensional ultrasound measurements with the actual myomas volume after surgical removal, to clinically test the validity and usability of 3D ultrasound technology as opposed to conventional 2D real-time ultrasound and to assess the reliability of different ultrasound methods to measure volume of uterine fibroids.
Conditions: Gynecology
Intervention / Treatment:
OTHER: ultrasound
| Inclusion Criteria:
* surgical intervention
Exclusion Criteria:
* unfit for surgery | 34,018 |
Study Objectives
This clinical trial involves a radiation treatment called stereotactic radiotherapy in non-small cell lung cancer patients who have been determined to be ineligible for surgery. This treatment differs from conventional radiotherapy in the number of treatments, the radiation dose given per treatment, and the way the radiation beams are directed toward the cancer.
Conditions: Non-small Cell Lung Cancer
Intervention / Treatment:
PROCEDURE: radiation therapy
| Inclusion Criteria:
Consistent with most therapeutic oncology trials, patients are not actively "recruited," but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit.
All patients must be willing and capable to provide informed consent to participate in the protocol.
Eligible patients must have appropriate staging studies identifying them as AJCC stage I (T1 or T2, N0, M0) primary lung carcinoma. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. Histologic confirmation will be required by either biopsy or cytology. The following primary cancer types are eligible: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, bronchioloalveolar cell carcinoma or non-small cell; not otherwise specified.
The primary tumor must be deemed technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection, PCR); however, the patient should have underlying physiological medical problems that would prohibit a PCR due to a low probability of tolerating general anesthesia, the operation, the post-operative recovery period, or the removal of adjacent functioning lung. Standard "cut-off " guidelines regarding surgical resection of NSCLC include the following: Baseline FEV1 <40%, post-operative predicted FEV1 <30%, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia and exercise oxygen consumption <50% predicted.
Patients who refuse a PCR due to preference, ideology, emotional or psychological issues, mental illness, or inability to give consent for the PCR and who have no specific accepted medical contraindications for the PCR are not eligible.
Eligible patients should not have had previous lung or mediastinal radiotherapy.
There must be no plans for the patient to receive other concomitant antineoplastic therapy while on this protocol. Patients who have received chemotherapy within 8 weeks of the start date of study are ineligible.
Patients must be able to fit inside the stereotactic body frame and able to undergo a CT or MRI scan in the frame.
The patient's primary tumor must not be larger than 7.0 cm in greatest dimension.
Patients with active systemic, pulmonary, or pericardial infection are ineligible.
Pregnant or lactating women are ineligible. Women/men of reproductive potential may not participate unless they agreed to use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.
Patients must be past their 18th birthday at time of registration. Karnofsky performance status > 60.
*
Exclusion Criteria:
See inclusion criteria.
* | 12,585 |
Study Objectives
This pilot study will investigate the safety and effect of etanercept in HIV infection by studying HIV replication and immune function (as measured by CD4 counts) in individuals with HIV infection.
Conditions: HIV Infections
Intervention / Treatment:
DRUG: etanercept
| Inclusion Criteria:
* Adults greater than 18 years of age with documented HIV infection
* Highly active antiretroviral therapy (HAART) regimens as defined by the Department of Health and Human Services guidelines; stable regimens for 12 weeks.
* CD4 greater than 200 at time of study enrollment
* Stable monitoring labs (hematology survey with differential, ALT, creatinine)
* Absolute neutrophil count within normal limits
Exclusion Criteria:
* AIDS defining illness within the last 6 months
* Acute bacterial, viral, or fungal infection within the last 1 month, or history of recurring infections
* Women who are pregnant or nursing
* Hypersensitivity to etanercept
* Previous use of etanercept
* Acute malignancy in the last 5 years excluding in situ cervical cancer (CA) and common skin cancers (non melanoma)
* History of active or latent tuberculosis
* History of demyelinating nerve disease
* History of seizure disorder
* Latex allergy
* Subject has any of the following laboratory values within 30 days of baseline:
* hemoglobin concentration < 10.0 g/dl for men and < 9.0 g/dl for women
* platelet count < 75,000/mm3
* AST or ALT > 5x upper limit of normal (ULN)
* serum creatinine > 2.5x ULN
* serum pancreatic amylase > 1.5 ULN
* Subject requiring treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, vaccines, or interferon
* Subjects who chronically use any over-the-counter (OTC) or prescription medication (except vitamins) must not change the regimen or switch their medication within 3 days of drug administration and until discharged from the study. | 18,357 |
Study Objectives
This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer who have achieved at least stable disease on first-line chemotherapy.
Conditions: Urothelial Carcinoma, Bladder Cancer
Intervention / Treatment:
OTHER: Placebo, DRUG: Pembrolizumab
| Inclusion Criteria:
* Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
* Age ≥ 18 years at the time of consent.
* ECOG Performance Status (PS) of ≤ 1 within fourteen days of registration for protocol therapy.
* Histological or cytological evidence of urothelial cancer of the bladder, urethra, ureter, or renal pelvis. Differentiation with variant histologies (e.g., squamous cell differentiated) will be permitted provided that the predominant histology is urothelial carcinoma.
* Metastatic and/or unresectable (cT4b) disease
* Must have achieved an objective response (CR/PR) or stable disease (SD) after 4 to 6 cycles of standard first-line platinum-based chemotherapy for mUC (e.g., as per NCCN guidelines). Able to commence study treatment within 2 to 6 weeks of receiving last dose of first-line chemotherapy.
* All subjects must have adequate archival tissue available prior to registration (i.e., at least 20 unstained slides or paraffin block). If acceptable archival tissue is not available, the subject must be willing to consent to providing a core or excisional biopsy for research prior to registration for protocol therapy. If archival tissue is not available and there are no sites amenable to biopsy, enrollment must be discussed with the sponsor-investigator on a case by case basis.
* Female subjects of childbearing potential must have a negative serum pregnancy within three days prior to registration for protocol therapy
* Sexually active, pre-menopausal women of childbearing potential must be willing to use an adequate method of contraception or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study drug. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > one year.
* Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.
Exclusion Criteria:
* More than one line of prior chemotherapy for metastatic or locally advanced disease, with the following exception:
* Prior neoadjuvant/adjuvant chemotherapy will not count as line of therapy if completed greater than 12 months prior to initiation of chemotherapy regimen for metastatic or unresectable disease.
* Current or past participation in a study of an investigational agent or using an investigational device within four weeks of registration for protocol therapy.
* A diagnosis of immunodeficiency or is receiving treatment with systemic steroid therapy or any other form of immunosuppressive therapy within seven days prior to registration for protocol therapy.
* Prior chemotherapy, targeted small molecule therapy, or radiation therapy within two weeks prior to registration for protocol therapy. Note: If the subjects have undergone major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting protocol therapy.
* A known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
* A known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 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 registration for protocol therapy 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 seven days prior to registration for protocol therapy.
* Active autoimmune disease that has required systemic treatment in 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.
* Has evidence of active, non-infectious pneumonitis.
* Has a history of interstitial lung disease.
* An active infection requiring systemic therapy.
* A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening period through 120 days after the last dose of protocol therapy.
* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). Examples include nivolumab, MPDL3280, etc.
* A known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* A known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
* Receipt of a live vaccine within 30 days prior to registration for protocol therapy.
* Unresolved toxicity (i.e., > Grade 1 or above baseline) due to previously administered agents. Exception includes: subjects with ≤ Grade 2 neuropathy are eligible for the study. | 5,464 |
Study Objectives
The investigators have developed a portable, battery-operated, mobile high-resolution microendoscope (mHRME) that provides subcellular images of the anal epithelium, delineating the cellular and morphologic changes associated with neoplasia. The investigators' central hypothesis is that this 'optical' approach will increase the efficiency, clinical impact, and cost-effectiveness of the current standard of high-resolution anoscopy(HRA)-guided biopsy, thus facilitating usage by less-experienced clinicians in community-based or low-resource settings. To validate this, the investigators will conduct a study to determine the efficiency and diagnostic characteristics of the mHRME 'optical biopsy' approach versus the current standard of HRA-based tissue biopsy. Successful results will allow for improved efficacy and resource utilization for cancer screening in people living with HIV for anal cancer and other epithelial cancers including the cervix, oral cavity, bladder, and GI tract.
Conditions: Anal High Grade Squamous Intraepithelial Lesion
Intervention / Treatment:
DIAGNOSTIC_TEST: mHRME (Mobile High resolution microendoscope), DRUG: Proflavine Hemisulfate, DIAGNOSTIC_TEST: High resolution anoscopy
| Inclusion Criteria:
* Consentable patients with documented HIV disease
* Either: 1) previously documented HSIL or 2) abnormal anal cytology within the past 2 years
* Ages 18 years and older
* Seen at the Baylor-affiliated Thomas Street Clinic (TSC), Mount Sinai Hospital and affiliated clinics
Exclusion Criteria:
* Unable to undergo routine anoscopy
* Allergy or prior reaction to the fluorescent contrast agent Proflavine or Iodine
* Unable to give informed consent
* Current or prior history of Invasive Anal Cancer
* Known permanent or irreversible bleeding disorder, or other hematologic disorder that in the opinion of the investigator would place the patient at increased risk for adverse outcome from the procedure
* Pregnancy | 21,046 |
Study Objectives
The purpose of the trial is to detect tumor microenvironment on Extensive Stage Small Cell Lung Cancer with simultaneous liver metastases who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy.
Conditions: Extensive Stage Small Cell Lung Cancer
Intervention / Treatment:
DRUG: First line EC/EP+Atezolizumab
| Inclusion Criteria:
* 18, Extensive Stage Small Cell Lung Cancer Confirmed by Histopathology Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy
Exclusion Criteria:
* Patients with contraindication of chemotherapy Pregnant or breast feeding women | 29,046 |
Study Objectives
Ovarian cancer is third most common gynecologic cancer in Thai woman, treatment including surgery followed by chemotherapy.
Patient usually received paclitaxel every 3 week for 6 cycles, paclitaxel induce peripheral neuropathy is common dose dependent side effect which can disturb quality of life, result in chemotherapy dose reduction or discontinuation leading to poor prognosis and decreased survival Mechanism of PIPN including inflammation, promotion of microtubule polymerization and inhibition of depolymerization, and oxidative stress N-acetylcysteine is acetylated form of l-cysteine, might reduce oxidative stress. NAC can restore glutathione level, which is potent natural antioxidant. NAC might reduce PIPN
Conditions: Chemotherapy-induced Peripheral Neuropathy
Intervention / Treatment:
DRUG: N Acetylcysteine A, DRUG: N Acetylcysteine B
| Inclusion Criteria:
* Female patient aged 18 years old or more with ovarian, tubal, and peritoneal cancer who received Paclitaxel first course after surgery
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Normal laboratory testing
* hemoglobin ≥10 g/dL, leukocyte count ≥ 3,000/mL, absolute neutrophil count ≥1,500/mL, platelet count ≥100,000/mL
* Serum creatinine ≤1.5 mg/dL
* Bilirubin ≤1.5 upper limit of normal
* Alkaline phosphatase and serum glutamic oxaloacetate transaminase ≤3 upper limit of normal
Exclusion Criteria:
* Patient with symptoms of peripheral neuropathy before study
* Allergy to N-acetylcysteine
* Psychiatric disorders
* Pregnant woman
* History of treated with other chemotherapy or radiotherapy before study | 38,461 |
Study Objectives
The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.
Conditions: Breast Cancer, Leukemia, Myeloid, Chronic
Intervention / Treatment:
DRUG: Bosutinib
| Inclusion criteria (for both study populations):
* Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening.
WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year (with follicle-stimulating hormone \[FSH\] level greater than or equal to 8 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after test article administration.* Have a high probability for compliance with and completion of the study.
Exclusion criteria (for both study populations):
* History of clinically important cardiovascular disease.* Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death.* Presence or history of any disorder that may prevent the successful completion of the study.
Other inclusion and exclusion criteria apply. | 36,405 |
Study Objectives
This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.
Conditions: Adenocarcinoma of the Pancreas, Metastatic Pancreatic Cancer, Pancreatic Cancer
Intervention / Treatment:
OTHER: Placebo, DRUG: AMG 479, DRUG: AMG 655
| Inclusion Criteria:
* Untreated metastatic adenocarcinoma of the pancreas (AJCC Stage IV)
* Subjects with unresectable pancreatic cancer who have had surgery are eligible if fully recovered and greater than 30 days have elapsed since the surgery.
Subjects with a history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
* Men or women ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Adequate hematologic, hepatic, renal and coagulation function
* Amylase and lipase ≤ 2.0 x ULN
* Adequately controlled type 1 or 2 diabetic subjects
Exclusion Criteria:
* Islet cell, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma
* Known central nervous system metastases
* Uncontrolled cardiac disease or any other co-morbid disease that would increase the risk of toxicity
* Adjuvant chemotherapy or chemoradiotherapy | 21,465 |
Study Objectives
An early phase II, single arm, two stage study, to investigate the level of activity, duration of response and tolerability of brentuximab vedotin (SGN-35), as a single agent, utilising a response adapted approach, in older, frailer or co-morbid patients with previously untreated Hodgkin lymphoma.
Opened Feb 2014 and will recruit over 18 months. Duration of treatment will be dependent on the patients' response (see schema below) with a maximum of 16 cycles over 48 weeks.
At the end of treatment patients will be assessed clinically at 3 months intervals and by CT scan at 15, 18, 24 and 36 months. For those still alive and disease free after 2 years, follow-up will be according to local practice.
Conditions: Hodgkin Disease
Intervention / Treatment:
DRUG: Brentuximab Vedotin
| Inclusion Criteria:
* Histologically confirmed CD30 positive classical Hodgkin lymphoma* No previous treatment for classical Hodgkin lymphoma* Aged ≥ 16 years* Stages II (with B symptoms, extranodal disease, bulky disease, ≥3 sites of nodal involvement, fewer than 3 sites of nodal involvement but unsuitable for radiotherapy because of anatomical distribution or ESR ≥50 mm/h), III and IV classical Hodgkin lymphoma* Any of the following:
At any age and with ECOG score of 0, 1, 2 or 3, for whom standard chemotherapy considered inappropriate because:
* Impaired cardiac function defined either by an ejection fraction of < 50% assessed by echocardiogram or nuclear medicine scan (MUGA)
* Left ventricular ejection fraction ≥50% measured by echocardiography or MUGA but in the presence of significant co-morbidities or cardiac risk factors such as diabetes mellitus, hypertension, peripheral vascular disease, ischaemic heart disease, previous myocardial infarction, obesity, stroke or transient ischaemic attacks (TIA) that make anthracycline-containing chemotherapy inadvisable as determined by the investigator.
* Heart failure clinically determined by the presence of New York Heart Association (NYHA) heart failure grade II and III due to a cause other than Hodgkin Lymphoma
* Impaired respiratory function with DLCO and/or FVC/FEV1 ratio <75% of predicted due to a cause other than Hodgkin lymphoma
For patients aged 60 years or older,
* an ECOG score of 1, 2 or 3 for any reason, before the start of permitted steroids (see section 7.9) and considered unsuitable for treatment with standard chemotherapy by the investigator
All co-morbidities must be documented on the baseline form and the CIRS-G score (if 60 years or older) recorded.* FDG avid disease - proven by PET scan* Measurable disease with at least one lesion measuring >1.5 cm in long axis diameter (for nodal lesions) or >1.0cm in long axis diameter (for extra-nodal lesions)* Written informed consent* Able to comply with requirements of the protocol (including PET scans)* Agree and be able to use adequate contraception if required
Exclusion Criteria:
* Nodular lymphocyte predominant Hodgkin lymphoma* Grade 2 or worse peripheral neuropathy* Haemoglobin <90 g/L (transfusion allowed)* Unsupported neutrophil count <1.0 x 109/l and platelet count <100 x 109/l unless due to bone marrow infiltration by Hodgkin lymphoma demonstrated by trephine biopsy* Serum bilirubin ≥1.5 times upper limit normal unless due to Hodgkin lymphoma or Gilbert's syndrome* Creatinine clearance <30 ml/min (calculated by the modified Cockroft-Gault formula, see appendix) unless due to Hodgkin lymphoma. Patients with an eGFR <30 ml/min but a measured GFR by another method (e.g. EDTA) of 30ml/min or greater would be eligible.* Pregnant or lactating women* Any other cancer diagnosis within the last 24 months - except for:
* Appropriately treated superficial melanoma, basal cell carcinoma and squamous cell carcinoma of the skin
* Appropriately treated cervical intra-epithelial neoplasia
* In situ or organ confined prostate cancer not currently requiring therapy
Previous cancers treated with curative intent and with no evidence of recurrence following a minimum of at least 2 years of follow-up are permitted.* The use of other investigational or anti-neoplastic agents within the previous 6 weeks or during the trial.* Known to be HIV, Hep B positive (Hep B Core antibody positive allows inclusion providing surface / core antigen both negative) or Hep C positive (Hep C antibody positive allows inclusion providing PCR for viral RNA is negative).* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.* Known cerebral or meningeal involvement by Hodgkin lymphoma* Symptoms or signs of progressive multifocal leukoencephalopathy (PML)* Any active systemic viral, bacterial, or fungal infection requiring intravenous antimicrobials within 2 weeks prior to registration* Evidence of current uncontrolled cardiovascular conditions, including unstable angina and NYHA grade IV heart failure* ECOG 4 at registration | 32,205 |
Study Objectives
To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: midostaurin (PKC412)
| Inclusion Criteria:
* Diagnosis of c-KIT mutated t(8;21) AML i.e.
1. >20% myeloid blasts in bone marrow and/or peripheral blood at initial diagnosis
2. Plus cytogenetic diagnosis of aberration t(8;21)/AML1-ETO
3. Plus mutation of c-KIT gene (mut-KIT17 or mut-KIT8) or FLT3-ITD mutation or both c-KIT and FLT3-ITD mutations
* Chemoresponsive disease as determined by early bone marrow assessment on day 14-16 after first cycle of induction therapy with cytarabine in combination with daunorubicine or idarubicine, or mitoxantrone- Fit for further intensive chemotherapy
* Age 18-65 years
* ECOG performance status of 0-2
* Life expectancy of at least 12 weeks
Exclusion Criteria:
* Primary refractory or previously relapsed AML
* Non-eligibility for high-dose cytarabine based consolidation, e.g. intolerance to cytarabine
* Inability to swallow oral medications
* Symptomatic congestive heart failure
* Bilirubin >2.5 x upper limit of normal | 30,152 |
Study Objectives
In renal cell carcinoma (RCC) patients, lymph node metastases detection and treatment are the most critical issues in daily clinical decision-making. Indeed, conversely to other oncological settings, a) nodal status imaging, b) sentinel node technique and c) standard lymphadenectomy have been demonstrated inadequate in the staging and management of RCC patients. A novel, accurate, standardized imaging technique is urgently needed in RCC setting to detect macro and micro nodal invasion, to identify those patients who are at higher risk of having nodal metastases, to accurately plan the best management. Recent studies suggested combining 18F-FAZA PET with CT scanning in the detection of cancer-induced hypoxia.The investigators propose to test 18F-FAZA PET-CT in detecting nodal metastases to improve the management of RCC patients.
Conditions: Renal Cell Carcinoma (RCC)
Intervention / Treatment:
OTHER: 18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS
| Inclusion Criteria:
* age of at least 18 years with diagnosis of RCC;
* patients candidates to radical nephrectomy and extended lymphadenectomy
* clinical T4 cancers or renal masses with evidence of lymphadenopathies at preoperative CT scan or larger tumor (max diameter>10 cm)
* performance status 0-1;
* expected survival time of at least 3 months;
* recovery from toxic effects of any previous treatment;
* serum biochemical and haematological measurements within healthy parameters.
* Female patients of childbearing age were requested to have a negative pregnancy test
* ability to understand and understand informed consent
* acceptance and signature of informed consent
Exclusion Criteria:
* other medical conditions that might limit the amount of antibody to be administered;
* New York Heart Association Class III/IV cardiac disease;
* pregnancy and breastfeeding
* eGFR<30;
* women of child-bearing age who do not agree to use contraceptives to avoid pregnancy;
* history of autoimmune hepatitis;
* allergy to iodine;
* unavailability or immunological and clinical follow-up assessments;
* participation in another clinical trial involving an investigational agent within 4 weeks of study enrolment | 35,768 |
Study Objectives
This is a pilot study to evaluate the feasibility of a mobile health exercise intervention (GO-EXCAP Mobile App) over 7 weeks in 25 patients with myeloid neoplasms receiving hypomethylating agents.
Conditions: Intervention
Intervention / Treatment:
BEHAVIORAL: GO-EXCAP Mobile App
| Inclusion Criteria:
* Age is greater than or equal to 60 years
* Have a diagnosis of MN
* Receiving outpatient chemotherapy (e.g., HMA)
* English speaking
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* No medical contraindications for exercise per oncologist
* Able to walk 4 meters as part of Short Physical Performance Battery measured walk (with or without assistive device)
* Able to provide informed consent
Exclusion Criteria
Platelet count of 10,000 per microliter or less in the most recent blood draw (due to risk of spontaneous bleeding) prior to transfusion (i.e., patients are allowed to enroll if their platelet count is 10,000 per microliter or less but is scheduled to receive transfusion the day of consent) | 29,110 |
Study Objectives
Primary Objective:
To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.
Secondary Objectives:
* To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus aflibercept in patients with measurable disease (RECIST 1.1).
* To evaluate the immunogenicity of IV aflibercept.
Conditions: Neoplasm Malignant
Intervention / Treatment:
DRUG: Aflibercept AVE0005, DRUG: Leucovorin, DRUG: Irinotecan, DRUG: 5-Fluorouracil
| Inclusion criteria:
* Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) treatment is appropriate
Exclusion criteria:
* Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
* Eastern Cooperative Oncology Group (ECOG) >1
* Need for a major surgical procedure or radiation therapy during the study
* Diagnosis of squamous-cell lung cancer
* Cumulative radiation therapy to > 25% of the total bone marrow
* History of brain metastases
* Inadequate organ and bone marrow function
* Uncontrolled hypertension
* Evidence of clinically significant bleeding diathesis or underlying coagulopathy
* Prior FOLFIRI treatment but have not been appropriate for safety reasons
* Patients with known Gilbert's syndrome
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | 24,739 |
Study Objectives
Patients with recurrent, refractory or metastatic solid tumors have a dismal prognosis with few viable treatment options. Hydroxychloroquine (HCQ) is an agent that has been widely used to treat malaria. Because HCQ also inhibits autophagy, a process central to survival of cancer in the face of metabolic stress, including the effects of anti-cancer therapy, it is now in human cancer trials combined with other agents to attempt to boost the efficacy of those agents. Autophagy inhibition improves the activity of sorafenib in hepatocellular carcinoma.
Sorafenib is an oral multi-kinase inhibitor that blocks not only receptor tyrosine kinases such as KIT, VEGFR and PDGFR but also serine/threonine kinases along the RAS/RAF/MEK/ERK pathway.
The investigators propose to treat patients with refractory or relapsed solid tumors with sorafenib, to boost its efficacy while attempting to mitigate its toxicity by combining with HCQ.
Conditions: Refractory or Relapsed Solid Tumors
Intervention / Treatment:
DRUG: Sorafenib combined with Hydroxychloroquine
| Inclusion Criteria:
* Able to provide informed consent
* Not on immune-modulating drugs, except those used as study drug premedication, unless the principal investigator grants an exception (which exception must be documented in writing)
* Patients with relapsed or refractory solid tumors with no viable treatment options
* Measurable disease within 30 days of study enrollment
* Blood hemoglobin > 8.5 gm/dl within 7 days of study enrollment
* Absolute neutrophil count > 1000/mm3 within 7 days of study enrollment
* Platelet count > 50,000/mm3 within 7 days of study enrollment
* SGOT <10x upper limit of normal within 7 days of study enrollment
* No chemotherapy or radiation therapy in the 14 days prior to initiation of treatment on this study. No other concurrent chemotherapy, surgery or radiation therapy during this protocol except surgery or radiation therapy to control symptoms with concurrence of the principal investigator.
* No contraindication to any study treatment
* No active major medical problems, including untreated or uncontrolled infections
* If of reproductive potential, a negative urine or blood pregnancy test within 3 days of study enrollment, and agreement to use adequate contraception. In relevant subjects, pregnancy testing will continue monthly while on treatment unless the subject is no longer able to become pregnant or there is sufficient justification otherwise
* Not breast feeding
* Life expectancy > 6 months
* ECOG performance status < 2
* Age 18+ years
* No active substance abuse in the prior 6 months
* Not on digoxin or cimetidine
Exclusion Criteria:
* Contraindication or hypersensitivity to any study drug or its components or excipients
* Current pregnancy or breast feeding
* Inability to document adequate contraception if a female of reproductive potential
* Chemotherapy or radiation therapy within the 14 days prior to initiation of study treatment
* Prior treatment with sorafenib. Prior HCQ use is not an exclusion.
* Life expectancy < 6 months
* ECOG performance status > 2
* Symptomatic coronary artery disease (including uncontrolled angina, congestive heart failure, and the like)
* Uncontrolled hypertension (diastolic BP consistently >100 mm Hg or systolic BP consistently >160 mm Hg on a regular basis)
* Uncontrolled, symptomatic cardiac arrhythmia
* Active substance abuse in the prior 6 months | 31,763 |
Study Objectives
The purpose of this study is to determine proportion of patients presented a search allelic imbalance of expression of genes BRCA 1 and 2 in population with hereditary breast and/or ovarian cancer risk and negative for deletion mutation BRCA 1 and 2 genes
Conditions: Hereditary Breast and Ovarian Cancer Syndrome
Intervention / Treatment:
GENETIC: blood collection, GENETIC: blood collection
| Inclusion Criteria:
For patients
* Women with breast cancer and / or ovarian cancer meet criteria suggestive of a hereditary predisposition
* Deleterious mutation of BRCA1 and BRCA2 sought and not highlighted
* Age ≥ 18 years
* Agreeing to participate in the study (a collection of signed informed consent)
For control population
* Women with no history of breast and / or ovarian cancer and no family history of breast and / or ovarian cancer among family members on the 1st and 2nd degree before age 50 for breast cancer and before 60 years for ovarian cancer
* Agreeing to participate in the study (a collection of signed informed consent)
Exclusion Criteria:
For patients:
* Patients with a known deleterious mutation in BRCA1 and BRCA2
* Patients do not meet criteria suggestive of a hereditary predisposition
* Persons deprived of liberty or under guardianship (including guardianship)
For control population:
* Males
* Personal or family history of breast and / or ovarian cancer (breast or ovarian cancer in their family experienced 1st and 2nd degree before age 50 for breast cancer before age 60 for cancer ovarian)
* Persons deprived of liberty or under guardianship (including guardianship) | 13,810 |
Study Objectives
This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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 erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone.
Conditions: Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Malignant Pericardial Effusion, Malignant Pleural Effusion, Minimally Invasive Lung Adenocarcinoma, Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage IV Lung Non-Small Cell Cancer AJCC v7
Intervention / Treatment:
DRUG: Carboplatin, DRUG: Erlotinib, DRUG: Erlotinib Hydrochloride, DRUG: Paclitaxel
| Inclusion Criteria:
* Histologic documentation of primary lung adenocarcinoma including any variant thereof such as pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma; patients with non-small cell lung cancer (NSCLC) not otherwise specified (NOS) are not eligible
* Pathology block or unstained slides from initial or subsequent diagnosis must be available for sequencing of EGFR, K-ras, Erb-2 and B-raf; patients need to have had at least a core biopsy; patients whose diagnosis was made through a fine needle aspirate will not have sufficient material for mutational analysis and are not eligible
* Select stage IIIB with cytologically documented malignant pleural or pericardial effusion OR stage IV disease
* Patients must be chemotherapy naïve; they may not have received neo-adjuvant or adjuvant chemotherapy
* No prior exposure to OSI-774 (erlotinib) or other treatments targeting the human epidermal growth factor receptor (HER) family axis (e.g., trastuzumab, gefitinib, cetuximab, lapatinib, etc.)
* No uncontrolled central nervous system metastases (i.e., any known central nervous system \[CNS\] lesion which is radiographically unstable, symptomatic and/or requiring corticosteroids); patients must be >= 3 weeks beyond completing cranial irradiation and off corticosteroid therapy
* >= 3 weeks since prior radiation therapy
* >= 3 weeks since prior major surgery
* No treatment with an investigational agent currently or within the last 28 days
* Non-smoker or former light smoker; non-smoker is defined as a person who smoked =< 100 cigarettes in their lifetime while a former light smoker is a patient who smoked between > 100 cigarettes AND =< 10 pack years AND quit >= 1 year ago; this must be documented on the On-study Form (C-1405)
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Non-pregnant and non-nursing
* No dysphagia or active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption; no lack of integrity of the gastrointestinal tract (e.g., a significant surgical resection of the stomach or small bowel); patients unable to swallow intact tablets must be able to swallow tablets dissolved in water
* Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; lesions that are considered non-measurable include the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Granulocyte >= 1,500/mcl
* Platelet count >= 100,000/mcl
* Hemoglobin >= 9.0 g/dL
* Total bilirubin =< upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =< 2.5 x ULN
* Creatinine =< 1.5 mg/dl | 13,325 |
Study Objectives
The objective of this study was to describe treatment patterns of leuprorelin over 2 years using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)
Conditions: Prostate Cancer
Intervention / Treatment:
| Inclusion Criteria:
* Histologically confirmed advanced PCa meeting the following criteria:
1. Any Tumor, Node 1, Metastasis 0
2. Any Tumor, Node 0, Metastasis 1 \[according to Tumor Node Metastasis classification 2009\]* Participants planned for administration of leuprorelin* World Health Organization status 0-1* Life expectancy at least 2 years
Exclusion Criteria:
* Contraindications to administration of leuprorelin:
1. Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition
2. Surgical castration* Hormone-refractory PCa* Presence of another malignant tumor (except skin cancer)* Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens* Previous administration of radiotherapy or chemotherapy course within 1 month* Testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion* Extremely high level of PSA (greater than or equal to 1000 ng/ml)* Other severe diseases in stage of decompensation* Other contraindications, that make the participant's participation impossible (by investigator judgment)* Previous enrollment in the present program | 15,241 |
Study Objectives
This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without bevacizumab before surgery (interval debulking surgery \[IDS\]). Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in participants with resectable cancer. Participants with unresectable cancer will go through the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: Carboplatin, DRUG: Paclitaxel, DRUG: Bevacizumab
| Inclusion Criteria:
* Histologically confirmed and documented high-risk FIGO stage IIIC/IV epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma
* Not eligible for primary complete debulking surgery during a laparoscopic procedure as judged by a surgeon experienced in management of ovarian cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Life expectancy greater than or equal to (>=) 3 months
* Eligible for carboplatin and paclitaxel chemotherapy in accordance with local standards
* Beneficiaries of healthcare coverage under the social security system
Exclusion Criteria:
* Non-epithelial ovarian cancer, ovarian tumor with low malignant potential, mucinous and clear cell ovarian cancer, or carcinosarcoma
* Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
* Previous systemic therapy for ovarian cancer
* Previous exposure to mouse CA-125 antibody
* Current or recent (within 28 days prior to Day 1 of Cycle 1) treatment with another investigational drug or previous participation in this study
* Current or recent (within 10 days prior to first study drug dose) chronic daily treatment with aspirin greater than (>) 325 milligrams (mg) per day
* Planned intraperitoneal cytotoxic chemotherapy
* Inadequate bone marrow, liver, or renal function
* History of myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to Day 1 of Cycle 1
* Uncontrolled hypertension
* Clinically significant (active) cardiovascular disease such as New York Heart Association (NYHA) Class II or greater congestive heart failure, or aortic aneurism
* Pre-existing peripheral neuropathy that is Common Toxicity Criteria (CTC) Grade >=2
* Known hypersensitivity to bevacizumab or its excipients, Chinese hamster ovary cell products or other recombinant humanized antibodies, or to any planned chemotherapy
* Pregnant or lactating females
* History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast | 23,659 |
Study Objectives
The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.
Conditions: Myelodysplastic Syndrome
Intervention / Treatment:
DRUG: Decitabine
| Inclusion Criteria:
* Must sign an Institutional Review Board (IRB) -approved informed consent form.* Must be 18 years of age or older.* Must have a diagnosis for MDS fitting any of the recognized French-American-British (FAB) classifications and International Prognostic Scoring System (IPSS) greater than or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. If FAB classification is Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks.* If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.* If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.
Exclusion Criteria:
* Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.* Must not have received any investigational agent within the 30 days preceding the first dose of study drug.* Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.* Must not have an active viral or bacterial infection. | 6,965 |
Study Objectives
This will be a randomized, open-label, multicenter, Phase II study with primary objectives to assess whether expression of select chemotherapy markers is associated with progression-free survival (PFS) in participants treated with bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) or bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI). The study population will consist of participants with first-line mCRC.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: 5-Fluorouracil, DRUG: Bevacizumab, DRUG: Irinotecan, DRUG: Leucovorin, DRUG: Oxaliplatin, DRUG: Capecitabine
| Inclusion Criteria:
* Histologically or cytologically confirmed colorectal cancer (CRC) with at least one measurable metastatic lesion by RECIST Version 1.1
* Archival tumor tissue sample must be requested and available prior to study entry. If no archival tumor tissue sample is available, a fresh biopsy tissue sample must be obtained but should be discussed first with the medical monitor. A copy of the local pathology report must be submitted along with the specimens.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Participants with treated brain metastases are eligible for study participation. Participants may not receive ongoing treatment with steroids at Screening. Anticonvulsants (at stable dose) are allowed. Treatment for brain metastases may be whole-brain radiotherapy, radiosurgery, neurosurgery, or a combination as deemed appropriate by the treating physician. Radiotherapy and stereotactic radiosurgery must be completed at least 28 days prior to randomization.
* Female participants should not be pregnant or breastfeeding. Female participants with childbearing potential should agree to use effective, non-hormonal means of contraception during the study and for a period of at least 6 months following the last administration of study drugs. Female participants with an intact uterus (unless amenorrheic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the study.
* Male participants must agree to use effective contraception during the study and for a period of at least 6 months following the last administration of study drugs, even if they have been surgically sterilized.
Exclusion Criteria:
* Any prior systemic treatment for mCRC
* Adjuvant chemotherapy for CRC completed <12 months
* Evidence of Gilbert's syndrome or of homozygosity for the UGT1A1\*28 allele
* Known positivity for human immunodeficiency virus (HIV)
* Malignancies other than mCRC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
* Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions within 14 days prior to randomization
* Clinically detectable third-space fluid collections that cannot be controlled by drainage or other procedures prior to study entry
* Treatment with any other investigational agent, or participation in another investigational drug trial within 28 days prior to randomization | 14,702 |
Study Objectives
The primary objectives of this study are to assess the feasibility (completion of full treatment) in both arms and to assess endoscopic complete response rate in both arms.
The secondary objective of this study is to assess the toxicity profile of each arm using the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) scale (V.3).
Conditions: Esophageal Neoplasms
Intervention / Treatment:
DRUG: FOLFOX 4, DRUG: 5-FU / Cisplatin
| Inclusion Criteria:
Patients with:
* Histologically proven adenocarcinoma, squamous cell or adenosquamous carcinoma of the esophagus
* Inoperable esophageal carcinoma (disease status: any T, N0 or N1, M0 or M1a) or surgical contraindication conditions
* No prior treatment for esophageal cancer (surgery, laser, chemo- or radiotherapy)
* Oesophageal dilatation is allowed before or during the treatment, but prior esophageal prosthesis is not allowed
* Peripheral neuropathy <= NCI-CTC grade 1
* Age >= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2
* Sufficient (oral or with gastrostomy) calorific intake (> 1000 Kcal/m2/day)
* Life expectancy >= 3 months
* Adequate bone marrow reserve, normal renal and liver functions:
* Neutrophil count >= 1500/mm³
* Platelet count >= 100,000/mm³
* Hemoglobin >= 10 g/dl (after transfusion, if necessary)
* Creatinine levels <= 1.5 x the upper normal limit of institutional values (ULN)
* Total bilirubin level < 1.5 x ULN
* ALT/AST < 2.5 x ULN
* Prothrombin time >= 60%
* Laboratory values obtained the week preceding study entry
* Signed informed consent (prior to all study procedures)
* Start of treatment within 28 days of inclusion.
Exclusion Criteria:
* Metastatic disease except for third upper or cervical esophagus tumor with regional nodes, or third lower esophagus tumor with celiac nodes (M1a)
* Multiple carcinomas of the esophagus
* Small cell or undifferentiated carcinoma of the esophagus
* Complete dysphagia (grade 4 NCI-CTC); patient with exclusive parenteral nutrition.
* Weight loss > 20% normal body weight
* Pregnant or breast-feeding women
* Fertile patient not using adequate contraception
* Peripheral sensitive neuropathy with functional impairment
* Auditory disorders
* History of prior malignancies (other than cured non melanoma skin cancer, cured cervical carcinoma in situ or stage I or II node negative head and neck cancer cured > 3 years ago)
* Prior cervical, thoracic and abdominal radiotherapy with field overlapping the proposed oesophageal radiotherapy field
* Tracheo-oesophageal fistula or invasion of the tracheo-bronchial tree
* Previous myocardial infarction (inferior or equal to 6 months). Patients with a previous myocardial infarction superior to 6 months, could be included only if: no transient ischemia is shown by thallium myocardial scintigraphy and favourable advice for chemotherapy is obtained from a cardiologist.
* Other serious illness or medical conditions (such as symptomatic coronary disease, left ventricular failure or uncontrolled infection)
* Arterial disease stage II to IV according to the Leriche and Fontaine classification
* Treatment with any other experimental drugs or participation in another clinical trial within 30 days of study screening
* Concurrent treatment with any other anti-cancer therapy
* Concurrent treatment with phenytoin and yellow fever vaccine; geographical, social or psychological circumstances preventing regular follow-up.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | 18,881 |
Study Objectives
The purpose of this study is to study the effects of isavuconazole in preventing fungal infections in patients who have had a hematopoietic stem cell transplant (HCT).
Conditions: Hematologic Malignancy, Myeloproliferative Disorder
Intervention / Treatment:
DRUG: Isavuconazole
| Inclusion Criteria:
* Subjects of greater than or equal to 18 years of age of either sex and of any race.
* Have received first peripheral blood, marrow or cord blood transplant from a family or unrelated donor for hematologic malignancy or myeloproliferative disorder.
Exclusion Criteria:
* Proven or probable aspergillosis or other mold infection or deep mycoses including hepatosplenic candidiasis less than 60 days from first dose of ISA.
* History of allergy or intolerance to ISA.
* Clinically significant elevation of liver function tests prior to the first day of dosing (FDD) that at the discretion of the treating physician would preclude the administration of an azole antifungal.
* Familial short QT syndrome. | 10,115 |
Study Objectives
The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy induced oral mucositis and xerostomia and improving quality of life in head and neck cancer patients. This is a randomized, double-blind, placebo controlled trial conducted in head and neck cancer patients. Mixed-block randomization is used to divide eligible patients into two groups: melatonin 40 mg or matched placebo. The patients are required to take the studied drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5 fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H\&N), pain (VAS 0-10) and adverse event frequency.
Conditions: Head and Neck Cancer
Intervention / Treatment:
DRUG: Melatonin, DRUG: Matched Placebo
| Inclusion Criteria:
* New diagnostic of head and neck cancer patient who need treatment with radiation involved with the oral cavity area.
* Never received radiotherapy or chemotherapy
* Karnofsky performance status > 70%
* Stopped smoking
* Able to eat and swallow medications
* Written informed consent
Exclusion Criteria:
* Melatonin allergy
* Active oral cavity inflammation scar
* Pregnancy
* Creatinine clearance < 30 ml/min
* Active periodontal disease
* Steroids or pain killer drugs used for oral cavity pain except NSAIDs for thromboembolism prevention
* Currently use benzydamine mouthwash | 33,710 |
Study Objectives
Research has found that patients sometimes have trouble obtaining oral (by mouth) cancer medications, understanding how to take these pills, handling side effects related to these drugs, and remembering to take these medications. The purpose of this research study is to have direct care nurses (DCNs) in the Thoracic Oncology Program (TOP) clinic provide teaching and follow-up to patients starting erlotinib (using a teaching tool) and to test the feasibility of providing education and follow-up. This study will also evaluate if increasing knowledge about erlotinib helps participants manage side effects and stay on their erlotinib without interruptions.
Conditions: Lung Cancer
Intervention / Treatment:
OTHER: Nursing Educational Intervention
| Inclusion Criteria:
* 18 years of age or older
* Non-small cell lung cancer diagnosis
* Patient/provider decision to start erlotinib monotherapy
* No prior treatment with erlotinib
* Willingness to follow the protocol visit schedule
* Ability to understand and converse in English
* No major physical or psychological limitation that would interfere with study participation
* Not participating in other studies involving nurse/patient interactions | 33,425 |
Study Objectives
Primary Objective:
To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only general anesthesia.
Secondary Objectives:
1. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative pain in the first 24 hours after surgery compared with patients having only general anesthesia.
2. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative nausea and vomiting in the first 24 hours as compared with patients having only general anesthesia.
3. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in a decreased length of hospital stay compared with patients having only general anesthesia.
Conditions: Breast Cancer
Intervention / Treatment:
PROCEDURE: Paravertebral Block, DRUG: Propofol, DRUG: Fentanyl, DRUG: Ropivacaine, DRUG: Midazolam
| Inclusion Criteria:
* Patients that consent to participate* Patients undergoing reconstructive breast surgery either in combination with oncologic surgery or alone* Patients that are female* Patients that are over the age of 18* Patients on anti-coagulants or other blood thinning medications will be eligible for inclusion if they stop taking these medications for at least the time specified below prior to date of surgery: Low molecular weight heparin must stop at least 36 hours prior to surgery. Coumadin must stop at least 5 days prior to surgery. Aspirin, Plavix and NSAIDs must stop at least 7 days prior to surgery.
Exclusion Criteria:
* Patients on chronic anti-emetics (ie. chronic= more than once every two days for greater than 2 weeks)* Patients on chronic pain medication (ie. chronic= more than once every two days for greater than 2 weeks) excluding Aspirin, acetaminophen and NSAID's* Patients with BMI<20 or >40* Patients that are pregnant* Patients with chronic pain syndromes.* Patients with hypersensitivity to ropivacaine/amide-type anesthetics should be excluded from this trial as this would be a contraindication | 28,390 |
Study Objectives
Study hypothesis:
The recurrence rate of HCC patients after radical resection is about 60-70%. This study is based on the hypothesis that CIK treatment could decrease the recurrence rate by 15% to 20%.
Abstract:
This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who underwent radical resection will be included. The patients will be randomized to group A (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer treatment after resection of HCC, and the randomize ratio will be 1:1.
Study treatment:
Patients in group A will receive 4 cycles of CIK treatments within 3 months after their liver resection. Patients in group B will have no anti-cancer therapy. Anti-virus and other supportive therapies are available in both groups.
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
BIOLOGICAL: cytokine-induced killer cell (CIK) treatment
| Inclusion Criteria
* Male or female patients > 18 years of age.
* Without any prior anti-cancer therapy.
* Patients who have a life expectancy of at least 12 weeks.
* Patients already had radical resection of HCC.
* Definition of radical resection in this study:
* All tumors were moved out, with a clean resection margin.
* Number of tumors <= 3.
* Without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein.
* No hepatic hilum lymphnode metastasis.
* No distance metastasis.
* Hepatocellular carcinoma with histological diagnose.
* No major post-operative complication.
* Patients who have an ECOG PS of 0, or 1.
* Cirrhotic status of Child-Pugh class A only.
* The following laboratory parameters:
* Platelet count >= 70 x 109/L
* Hemoglobin >= 8.5 g/dL
* Albumin >= 3.5 g/dL
* Total bilirubin <= 25umol/L
* Alanine transaminase (ALT) and AST <= 2.5 x upper limit of normal
* Serum creatinine <= 1.5 x the upper limit of normal
* Prothrombin time (PT) <= 3 seconds above control.
* Patients who give written informed consent.
Exclusion Criteria
* Previous or concurrent cancer that is distinct in primary site or histology from HCC.
* History of cardiac disease.
* Active clinically serious infections (> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0)
* Known history of human immunodeficiency virus (HIV) infection
* Known Central Nervous System tumors including metastatic brain disease.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* History of organ allograft.
* Known or suspected allergy to the investigational agent or any agent given in association with this trial.
* Pregnant or breast-feeding patients.
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
Excluded therapies and medications, previous and concomitant:
* Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy.
* Antiviral treatment is allowed. | 28,039 |
Study Objectives
The investigators are conducting a study to provide evidence about the comparative effectiveness of mailed, tailored intervention materials on cancer prevention behavioral outcomes. The investigators will send out three (3) tailored mailings for participants who are assigned to the intervention group. Second, during the eligibility screening, the investigators will be assessing the relative yield and functioning of two risk assessment tools (BRAT and FEARS) on determining an individual's level of risk for skin cancer.
Conditions: Melanoma, Skin Cancer
Intervention / Treatment:
OTHER: Surveys & Mailed Materials
| Inclusion Criteria:
To be included in Phase I, a subject must meet all of the following criteria:
* Subjects are capable of giving informed consent* Subjects are ≥ 18 years old.* Subjects are English speaking and can read English
To be included for analysis during Phase II, a subject must meet all of the following criteria:
* Subjects must meet all criteria listed in Phase I.* Subjects are identified as Caucasian.* Subjects must be at moderate or high risk for skin cancer, based on scores from the BRAT and Fears combined risk assessment.
Exclusion Criteria:
* Children under the age of 18 will not be included.* For Phase II, previously diagnosed with melanoma.* For Phase II, planning to be away for three (3) consecutive weeks or longer in June, July, or August | 34,095 |
Study Objectives
The investigators have recently demonstrated that argininosuccinate synthase 1 (ASS1) expression is silenced in 88% of all sarcomas (n=708), and that this loss is associated with a decreased overall survival. Using the extracellular arginine depleting enzyme PEGylated arginine deiminase (ADI-PEG20), an extracellular arginine depleting enzyme, the investigators demonstrated ADI-PEG20 induces a prosurvival metabolic reprogramming in ASS1-deficient sarcomas that redirects glucose into the serine/folate pathway directing the carbons from glucose into pyrimidine biosynthesis, thus sensitizing cells to death by the pyrimidine antimetabolite gemcitabine by using metabolomics. The synthetic lethality was increased by the addition of docetaxel. Therefore a phase II clinical trial of ADI with gemcitabine and docetaxel, a standard second line therapy for soft tissue sarcoma will be conducted to determine if the clinical benefit rate of gemcitabine and docetaxel is improved by the metabolic changes induced by ADI-PEG20.
Recently published data shows that priming ASS1-deficient tumors with ADI-PEG 20 and docetaxel improves the effect of gemcitabine. Therefore, a cohort of patients consisting of ten patients diagnosed with either osteosarcoma or Ewing's sarcoma (ideally five of each), and five patients diagnosed with small cell lung cancer will be included as an exploratory cohort. Enrollment to Cohort 2 will occur concurrently with Cohort 1.
Conditions: Soft Tissue Sarcoma
Intervention / Treatment:
DRUG: pegylated arginine deiminase, DRUG: Gemcitabine, DRUG: Docetaxel, PROCEDURE: Tumor biopsy, PROCEDURE: Research blood draw
| Inclusion Criteria:
* Cohort 1: Histologically or cytologically confirmed grade 2 or 3 soft tissue sarcoma that is unresectable or metastatic that would be standardly treated with gemcitabine or gemcitabine and docetaxel. For all others, please contact the principal investigator. Prior surgery for primary or metastatic disease after chemotherapy following a response is allowed.
* Cohort 2: Histologically or cytologically confirmed osteosarcoma, Ewing's sarcoma, or small cell lung cancer that is unresectable or metastatic that have either failed standard of care therapy or would be standardly treated with gemcitabine or gemcitabine and docetaxel.
* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
* Treated with at least one line of systemic therapy. The allowable window between treatments is 21 days for chemotherapy or a TKI, or 5 ½ half-lives for a TKI (whichever is shorter), 21 days and progression by CT for immunotherapy, 21 days for RT, 21 days for surgery, or 28 days for an investigational agent.
* Cohort 1: At least 16 years of age.
* Cohort 2: Patients with osteosarcoma or Ewing's sarcoma must be at least 10 years of age. Patients with small cell lung cancer must be at least 18 years of age.
* Cohort 2 (SCLC group ONLY): Must be amenable to biopsy
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Normal bone marrow and organ function as defined below:
* Leukocytes ≥ 3,000/mcL
* Absolute neutrophil count ≥ 1,500/mcl
* Platelets ≥ 100,000/mcl
* Total bilirubin ≤ 2 x institutional upper limit of normal (IULN)
* AST(SGOT)/ALT(SGPT) ≤ 3 x IULN (or ≤ 5 x IULN if liver metastases are present)
* Creatinine ≤ 1.5 x IULN OR
* Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
* Serum uric acid ≤ 8 mg/dL (with or without medication control)
* Women of childbearing 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 must inform her treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
* A history of other high grade malignancy ≤ 5 years previous. Exceptions include basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix, or other tumors discussed with the study PI
* Currently receiving any other investigational agents.
* Prior treatment with ADI-PEG 20, gemcitabine, or docetaxel. Patients treated > one year ago in the adjuvant/neoadjuvant setting with gemcitabine or docetaxel would be allowed to be enrolled on the trial.
* Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial (except for patients with SCLC, see below) because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with SCLC are allowed to enroll with brain metastases provided they are stable and they are at least 3 months post-treatment for brain metastases.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, gemcitabine, pegylated compounds, or other agents used in the study.
* 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.
* History of seizure disorder not related to underlying cancer.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study treatment. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. | 3,357 |
Study Objectives
The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: ABT-751
| Inclusion Criteria
* Stage IIIB or IV breast cancer.
* Recurrent tumor after or while on taxane therapy (taxol or taxotere).
* Able to tolerate normal activities of daily living.
* Adequate bone marrow, kidney and liver function.
Exclusion Criteria
* Pregnant or breast feeding.
* No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration. | 8,494 |
Study Objectives
This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, patients will be randomized to 4 group, receiving the treatment from senior acupuncturist, junior acupuncturist, junior acupuncturist by only acupuncture Neiguan(P6), or not receive the acupuncture. All patients receive the basic cisplatin chemotherapy. The duration of treatment is from the first day receiving cisplatin until two days after cisplatin on each group. NCI and Rhode scale will be used to measure the control of nausea and vomiting.
Conditions: Chemotherapy-induced Nausea and Vomiting
Intervention / Treatment:
PROCEDURE: Manual acupuncture implemented by senior acupuncturists, PROCEDURE: Manual acupuncture implemented by junior acupuncturists, PROCEDURE: Manual acupuncture on P6 point
| Inclusion Criteria:
* Confirmed diagnosis of cancer
* Must receive cancer chemotherapy containing cisplatin
* Use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
Exclusion Criteria:
* Concurrent neoplasms or illness that induces nausea independent of chemotherapy
* Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
* Severe infection
* Severe heart, liver, kidney and brain diseases
* Cardiac pacemaker
* Radiotherapy or hormone therapy during chemotherapy treatments | 36,678 |
Study Objectives
The study is intended to investigate the safety of BYL719 and AUY922 in patients with advanced gastric cancer, and to determine the MTD and/or RDE of both drugs in combination. In addition, the preliminary efficacy of BYL719 in combination with AUY922, and the pharmacokinetics of both drugs will be assessed. Patients will be eligible for this study, if their tumors carry either a molecular alteration of PIK3CA, or an amplification of HER2.
The study includes a dose escalation part followed by a safety expansion phase.
Conditions: Stomach Neoplasms Esophageal Neoplasms Metastatic Gastric Cancer Mutated PI3KCA Protein Overexpressed HER2 Protein
Intervention / Treatment:
DRUG: AUY922, DRUG: BYL719
| Inclusion Criteria:
* Patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction;
* Patients must not have a complete gastrectomy;
* gastric tumors carrying PIK3CA mutation or amplification, or HER2-overexpression, or both;
* at least one but no more than three previous lines of treatment for advanced or metastatic disease;
* Patients with PIK3CA mutated or amplified tumors must have failed at least one line but no more than three lines of standard chemotherapy and/or targeted agents;Patients with HER2 amplified tumor must have failed at least one line, but no more than three lines, with or without anti-HER2 therapy. All HER2 positive patients are expected to have received trastuzumab unless contraindications were present or trastuzumab was unavailable;
* Performance Status (PS) ≤ 1 ;
* Adequate bone marrow, liver and other organ functions and laboratory parameters;
* Recovery from all AEs of previous anti-cancer therapies, including surgery and radiotherapy, to baseline or to CTCAE Grade ≤ 1, except for alopecia;Negative serum pregnancy (β hCG) test within 72 hrs before starting study treatment in all pre-menopausal women and women < 12 months after the onset of menopause.
\* Exclusion Criteria:
* Progressive disease during or after prior combination treatment with PI3K-inhibitors and HSP90- inhibitors;
* history of prior significant toxicity from another PI3K- or HSP90- inhibitor requiring discontinuation of treatment;
* primary CNS tumor or uncontrolled CNS metastasest;
* Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment;
* Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus;Patients with diarrhea CTCAE Grade ≥ 2 ;
* Patients with acute or chronic pancreatitis; History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO;
* Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BYL719;
* Patients receiving chronic slow-release formulation of Proton Pump Inhibitors (PPI), H2-antagonists or other gastric pH elevating agents;
* Treatment with therapeutic doses of coumarin-based anticoagulants (e.g., warfarin sodium, Coumadin®). Low doses of courmarin-based anticoagulants;
* Patients receiving chronic or high dose corticosteroids therapy; other protocol-defined inclusion/exclusion criteria may apply. | 10,398 |
Study Objectives
The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma.
Hypotheses:
1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma.
2. Effective pain relief obtained from EUS-CPN will be related to better quality of life (QOL)
Conditions: Pancreatic Cancer
Intervention / Treatment:
DRUG: dehydrated alcohol
| Inclusion Criteria:
* A total of 20 consecutive subjects with locally advanced or unresectable pancreatic adenocarcinoma (stage II to IV) with pain (abdominal and/or back). Subjects with known or suspected unresectable pancreatic adenocarcinoma will be recruited for this study, as a diagnosis of unresectable pancreatic adenocarcinoma is often made during the endoscopic ultrasound (EUS) procedure.
* Subjects must have documented disease by computed tomography (CT), endoscopic retrograde cholangio-pancreatography (ERCP), or EUS.
* Subjects undergoing EUS for pancreatic cancer staging.
* Subjects undergoing pancreatic cancer surgery are eligible for study entry beginning 5 days after the operation if they have not had an intraoperative celiac plexus neurolysis.
* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
Subjects must not have a coagulopathy (platelet <50,000, INR>1.5, or bleeding disorder, or on blood thinners) Subjects with platelets below 50,000 will not be eligible to participate in this study due to the risk of bleeding. Patients will be asked to discontinue use of non-steroidals for 5 days prior to the procedure. Patients on plavix will be asked to discontinue use for 7 days prior to the procedure if they are clinically able to do so. Patients on coumadin or lovenox will also need to discontinue use prior to the procedure, but decisions regarding their management will be made on an individual basis as per our usual standards of care.
* Subjects must provide signed written informed consent.
* A baseline pain score is not required, however, subjects must be having pain that is requiring a stable dose of pain medication for control of pain.
Exclusion Criteria:
* Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical).
* Presence of an implanted epidural or intrathecal analgesic therapy. Subjects with psychiatric illness that affects their ability to assess quality of life or compliance with the protocol.
* Subjects with uncorrectable coagulopathy
* Subjects with an allergy to bupivacaine or alcohol.
* Presence of an aneurysm in the abdominal aorta, celiac trunk, or superior mesenteric artery. | 9,057 |
Study Objectives
This is a prospective Phase II study.The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule.
The characteristics of patients whose disease remains confined to limited areas in the long term, compared with those who do not will also be described.
Conditions: Solid Tumors With Oligometastatic Spread
Intervention / Treatment:
RADIATION: Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance
| Inclusion Criteria:
* Any solid tumors are eligible. Lymphoma, myeloma and germ cell tumors are excluded.
* Histological confirmation of neoplastic disease either from original primary or metastatic sites is required.
* Radiological diagnosis of oligometastastic metastatic disease is accepted if considered clinically acceptable. Histological confirmation is not mandatory.
* Oligometastatic disease, maximum of 5 lesions.
* At least one lesion is suitable for stereotactic body radiotherapy
* All known sites of disease have plans for local ablative management (see section management plan for definitions) within 3 months
* ECOG ≤ 2
* At least 18 yrs old
Exclusion Criteria:
* Previous radiotherapy to the intended treatment site
* Patient cannot tolerate physical set up required for SBRT
* Active bowel obstruction, if treating abdominal/pelvic site
* Chemotherapy within 2 weeks of intended radiation therapy
* Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
* Pregnancy | 630 |
Study Objectives
This study aim to analyze cost-effectiveness of robot-assisted surgery compared to open surgery for partial nephrectomy in the context of renal tumor. A total of 400 patients were recruited in two centers in France corresponding to Reims(n=200) and Nancy hospital center (n=200). Patients recruited in Reims are corresponding to open surgery strategy, while patients of Nancy center are corresponding to robot-assisted surgery.
Costs analyzed included cost of intervention, hospital stay and complications. Effectiveness measure is corresponding to the rate of patients without acute complication at one year.
Conditions: Renal Tumor
Intervention / Treatment:
PROCEDURE: Partial nephrectomy with robot-assisted and open surgery
| Inclusion Criteria:
* Patients undergoing partial nephrectomy surgery for renal tumor
* Patients that gave informed consent for participating to the study
Exclusion Criteria:
* Patients undergoing partial nephrectomy surgery for other indication
* Patients that refused participation to the study
* Patients with horseshoe kidney
* Patients undergoing total nephrectomy for renal tumor | 28,774 |