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Study Objectives
The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings.
This study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening.
Hypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.
Conditions: Human Papillomavirus 16, Human Papillomavirus 18, Papillomavirus Infections, Cervical Cancer, Pre-Cancerous Dysplasia
Intervention / Treatment:
BEHAVIORAL: Self-collected HPV testing for cervical cancer screening
| Inclusion Criteria:
* Women with no previous history of hysterectomy
* aged 25-49 years old
* no previous history of treatment for cervical cancer
* provided written informed consent.
Exclusion Criteria:
* Women who are under 25 or over 49 years of age,
* who have previously had a hysterectomy or been treated for cervical cancer
* unable to provided informed consent. | 9,358 |
Study Objectives
l'ANI (Analgesia Nociception Index
The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a parameter giving the possibility of measuring the pain in painful metastatic cancer. The parameter ANI is compared with visual analogical scale (VAS) score.
Conditions: Pain, Cancer
Intervention / Treatment:
DEVICE: Non Invasive Monitoring Device (ANI)
| Inclusion Criteria:
* more than 18 years, -no legal protection, -
* life expectancy is considered over 3-months
* not receiving of béta-blocking,
* Having a rhythm sinusal without extrasystole
* benefiting from a coverage by a social security system
Exclusion Criteria:
* Pace-Maker
* Diabetes mellitus | 16,431 |
Study Objectives
The goal of this clinical research study is to learn if lirilumab in combination with rituximab can help to control either CLL or Small lymphocytic lymphoma (SLL). The safety of the drug combination will also be studied.
Conditions: Leukemia, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia
Intervention / Treatment:
DRUG: Lirilumab, DRUG: Rituximab
| Inclusion Criteria:
* Patients will have a diagnosis of CLL or SLL who meet one or more criteria for active disease as defined by the International Working Group for CLL (IWCLL) and are: a. Cohort 1: refractory to and/or relapsed after at least one prior therapy OR b. Cohort 2: untreated patients with high-risk molecular features such as del(17p), mutated TP53, del(11q), unmutated IGHV gene, or are >65 years of age* Age 18 years or older* Eastern Cooperative Oncology Group (ECOG) Performance Status <=2* Patients must have adequate renal and hepatic function: Serum bilirubin <=1.5 x upper limit of normal (ULN). For patients with Gilbert's disease, serum bilirubin up to <=3 x ULN is allowed provided normal direct bilirubin; Serum creatinine ≤1.5 x ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 x ULN* Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (Beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for 12 months following the last dose of the study drugs. Females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 31 weeks following the last dose of study drugs.* Patients or their legally authorized representative must provide written informed consent.
Exclusion Criteria:
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized prostate cancer. If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer Center and after consultation with the Principal Investigator.* Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 4 weeks prior to the first dose of the study drugs. For oral targeted therapies (such as ibrutinib, idelalisib, venetoclax), a washout of 3 days is allowed. Note: Prior treatment with anti CD20 monoclonal antibody, anti CD52 monoclonal antibody and lenalidomide are allowed. Prior treatment with anti-CTLA-4 and anti-PD1 therapies is allowed after a wash-out of 5 half-lives.* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 2 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.* History of stroke or cerebral hemorrhage within 2 months.* Patients who have uncontrolled hypertension (defined as sustained systolic blood pressure >= 160 mmHg or diastolic >= 100 mmHg).* Known evidence of active cerebral/meningeal CLL. Patients may have history of central nervous system (CNS) leukemic involvement if definitively treated with prior therapy and no evidence of active disease at the time of registration.* Active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapy.* Patients with autoimmune diseases are excluded: Patients with a history of Inflammatory Bowel Disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, Wegener's granulomatosis).* Patients with previous allogeneic stem cell transplant (SCT) within 6 months or with active acute or chronic graft-versus host disease are excluded. Patients must be off immunosuppression for graft versus host disease (GVHD) for at least 60 days before Cycle 1 Day 1.* Patients with organ allografts (such as renal transplant) are excluded.* History of any hepatitis (e.g., alcohol or non-alcohol steatohepatitis (NASH), auto immune, or grade 3-4 drug-related hepatitis).* Patients who are on high-dose steroids (doses >10mg/day of prednisone or equivalent) or immune suppression medications. Note: Patients on high-dose steroids (doses >10mg/day of prednisone or equivalent) or immune suppression medications are eligible provided these drugs are discontinued at least 3 days prior to starting on the study drugs.* Patients with uncontrolled active infection (viral, bacterial, and fungal) are not eligible.* Current or chronic hepatitis B or C infection, or known seropositivity for HIV.* Patient is pregnant or breast-feeding.* Concurrent use of investigational therapeutic agent* Patients may not receive other concurrent chemotherapy, radiotherapy, or immunotherapy. Localized radiotherapy to an area not compromising bone marrow function does not apply.* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study. | 31,500 |
Study Objectives
* To investigate the effect of catecholamine excess on brown fat.
* To evaluate the effect of brown fat on energy expenditure and lipid and glucose metabolism
Conditions: Pheochromocytoma, Adrenal Incidentaloma
Intervention / Treatment:
PROCEDURE: Removal of adrenal tumor
| Inclusion Criteria:
* 10 patients with pheochromocytoma
* 5 patients with incidentaloma without hormone production
* Age > 18 years
Exclusion Criteria:
* None | 10,356 |
Study Objectives
This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.
Conditions: Soft Tissue Sarcomas, Bone Sarcomas
Intervention / Treatment:
DRUG: RAD001
| Inclusion Criteria:
* Patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response.
* Any of above drugs is allowed to be used as adjuvant treatment.
* Unidimensionally measurable disease
* 3 or less than prior chemotherapies
* Age 17 years old or older
* ECOG performance status 2 or less, Life expectancy 6 month or less
* Adequate bone marrow, liver, kidney, and cardiac function
* Written informed consent
Exclusion Criteria:
* Pregnant or lactating patients
* Patients with resectable metastasis
* Patients with history of CNS metastasis
* Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma
* Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
* Any preexisting medical condition of sufficient severity to prevent full compliance with the study | 38,285 |
Study Objectives
This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.
Conditions: Neuroendocrine Tumors
Intervention / Treatment:
DRUG: Pasireotide LAR
| Inclusion Criteria:
* ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma
* unresectable metastatic NET tumor with measurable disease
* life expectancy ≥ 12 weeks
Exclusion Criteria:
* Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
* patients with known hypersensitivity to somatostatin analogs
* patients with symptomatic cholelithiasis in the past 2 months
* patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix
* patients with known history of hepatitis C or chronic active hepatitis B
* patients with diagnosis of HIV.
Other protocol-defined inclusion/exclusion criteria may apply | 22,155 |
Study Objectives
This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant or tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving palbociclib together with fulvestrant or tamoxifen citrate may work better in treating hormone receptor positive breast cancer.
Conditions: Metastatic Breast Cancer, Hormone Receptor Positive
Intervention / Treatment:
DRUG: Palbociclib, DRUG: Tamoxifen, DRUG: Fulvestrant
| Inclusion Criteria:
* Histologically or cytologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent.
* Patients 18 years of age or older, Female patients should be either:
* Postmenopausal, as defined by at least one of the following criteria:
* Age >=60 years;
* Age <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause;
* Documented bilateral oophorectomy;
* Medically confirmed ovarian failure.
OR
* Pre/peri-menopausal, ie, not meeting the criteria for being postmenopausal who are also receiving ongoing treatment with Luteinizing hormone-releasing hormone (LHRH) agonists (goserelin or leuprolide). The first injection should occur at least two weeks before study start.
* Documentation of ER-positive and/or PR-positive tumor (≥1% positive stained cells) based on most recent tumor biopsy (unless bone-only disease,discuss with study PI if results are discordant) utilizing an assay consistent with local standards.
* Documented human epidermal growth factor receptor 2 negative (HER2-) tumor based on local testing on most recent tumor biopsy: HER2-negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17 ratio <2 or for single probe assessment a HER2 copy number <4.
* Must have received prior treatment with an Mechanistic target of rapamycin (mTOR) or phosphatidylinositol 3-kinase (PI3K) inhibitor
* Up to 2 prior lines of chemotherapy are allowed in the metastatic setting.
* Any number of lines of prior hormone therapy are allowed
* Patients with clear progression on either tamoxifen or fulvestrant should receive the alternate agent. Patients with clear progression on both drugs are not eligible.
* Ability to have a skin and tumor biopsy. Patients without accessible tumor for biopsy will be considered on a case by case basis.
* Patients who cannot be biopsied will not be replaced (although up to 5 ineligible/inevaluable patients can be replaced)
* A patient without biopsy amenable tumor must be cleared by the PI of the study; up to 10 patients without biopsy amenable tumor will be allowed in each arm of the study.
* Patients without accessible tumor for biopsy must provide archived tumor from the most recent biopsy available
* Bone marrow, hepatic, and renal function as follows:
Adequate bone marrow function:
* leukocytes > 2500/mL
* absolute neutrophil count > 1,000/mL
* platelets > 100,000/mL"
Adequate hepatic function:
* total bilirubin within normal institutional limits (unless Gilbert's disease with elevated indirect bilirubin only)
* aspartate aminotransferase (AST) / (serum glutamic-oxaloacetic transaminase (SGOT) < 2.5 X institutional upper limit of normal
* alanine aminotransferase (ALT) / (serum glutamic-pyruvic transaminase (SGPT) < 2.5 X institutional upper limit of normal
* Adequate renal function:
* creatinine within normal institutional limits
* Measurable or evaluable disease as defined by RECIST version 1.1. Tumor lesions previously irradiated or subjected to other loco-regional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Resolution of acute toxic effects of prior therapy or surgical procedures to National Cancer Institute (NCI) CTCAE Grade <=1 (except alopecia)
* Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria:
* Prior treatment with any cyclin-dependent kinase (CDK) inhibitor, and/or both fulvestrant and tamoxifen in the metastatic setting with clear progression.
* Patients with advanced/metastatic, symptomatic, visceral spread, at risk of life-threatening complications in the short term by investigator assessment.
* Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization .
* Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the prohibited medications section), and drugs that are known to prolong the QT interval. See prohibited meds in appendix 5.
* Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before randomization.
* Any other malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
* QTc interval >480 msec (based on the mean value of the triplicate ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.
QTc (Bazett) = QT/√RR
* Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, symptomatic congestive heart failure, or cerebrovascular accident excluding transient ischemic attack.
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of palbociclib, such as history of GI surgery with may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease or diarrhea of CTCAE v4.0 Grade >1.
* Prior hematopoietic stem cell or bone marrow transplantation.
* Abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants (that cannot be safely held for biopsy) that would preclude tumor and skin biopsies.
* For fulvestrant: Ongoing anticoagulation that would preclude an IM injection
* For tamoxifen: Documented hypercoagulable state not receiving anticoagulation
* Known or possible hypersensitivity to palbociclib (CTCAE v4.0).
* Known human immunodeficiency virus infection.
* Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product 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.
* Participation in other studies involving investigational drug(s) (Phases 1-4) within 2 weeks before randomization the current study.
* Women should not become pregnant or breastfeed whilst on this study. Birth control methods are acceptable and will be discussed with study participants. | 25,642 |
Study Objectives
This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities:
1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)
2. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.
Conditions: Breast Cysts, Breast Tumors
Intervention / Treatment:
PROCEDURE: X-ray and ultrasound imaging scanning, PROCEDURE: Photoacoustic imaging scans for breast cancer screening
| Inclusion Criteria:
* Women with possible masses
* All women should have had mammograms at University of Michigan Health System within 1 year before this research study.
Exclusion Criteria:
* Women who are physically unable to tolerate the length of the scan.
* Women who are less than 30 years of age or older than 80 years of age
* Women who are pregnant or lactating
* Women whose mass is in an area of the breast which makes it difficult to see in the research scans
* Womens with a single diagnosis of mammographic calcifications
* Women who have had a breast cancer with lumpectomy
* Women who are prisoners
* Women who are students or staff of investigators
* Women who cannot give consent
* Women with mammograms classified as probably benign because of follow-up of a recent benign biopsy.
* Women with breast pain who have been categorized as BIRADS(Breast Imaging Reporting and Data System) category 0(incomplete) on their most recent mammograms.
* Males, because their breast tissue is not easily imaged and numbers of potential cases are too few. | 37,629 |
Study Objectives
The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally advanced gastric cancer undergoing standard surgical resection. Patients will be treated with HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90 minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed after resection but before anastomosis.
Conditions: Locally Advanced Malignant Neoplasm, Gastric Cancer
Intervention / Treatment:
DRUG: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
| Inclusion Criteria:
* Patients aged 18-75 with biopsy-proven gastric adenocarcinoma* Tumor clinically staged T3 or T4 and/or nodes staged clinically positive* ECOG performance status < 2
Exclusion Criteria:
* Distant metastases* Peritoneal carcinomatosis* Synchronous malignancy* Tumors at the gastroesophageal junction* Recurrent gastric adenocarcinoma* Creatinine >= 1.5* Bilirubin >= 2* INR >= 2* Allergy to drugs included in the treatment plan* Pregnancy* Contraindication to major surgery | 16,787 |
Study Objectives
HPV is known to be the causal agent in the majority of cervical cancers. However, the role of the cervical bacterial microbiome in cervical cancer is not clear
Conditions: Cervix Cancer
Intervention / Treatment:
DIAGNOSTIC_TEST: Cervical biopsy
| Inclusion Criteria:
* Women in fertile age
Exclusion Criteria:
* severe comorbidities | 12,833 |
Study Objectives
This study was aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients after highly emetogenic chemotherapy.
Conditions: Neoplasms
Intervention / Treatment:
DRUG: Thalidomide, DRUG: Placebo for thalidomide, DRUG: Palonosetron and Dexamethasone
| Inclusion Criteria:
* 18y ≤Age≤70y
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Histologically confirmed solid neoplasm
* No prior chemotherapy
* Laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥85×109/L, creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), blood glucose ≤11.1 mmol/L
* Life expectancy of at least 12 weeks
* Signed informed consent
* For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment
* Cancer patients scheduled to receive HEC regimen. The HEC regimen was defined as chemotherapy containing a 50 mg/m2 or higher dose of cisplatin, or cyclophosphamide combination with doxorubicin/epirubicin
Exclusion Criteria:
* Diabetic patients
* Pregnant or lactated women
* Patient with history of thrombosis
* Concomitant radiotherapy
* Known hypersensitivity to thalidomide, palonosetron, or dexamethasone.
* Concurrent administration of any other drug which affect antiemetic effect evaluation such as proton pump inhibitor, H2 blocker, amifostine, sedative drugs
* CHOP regiment or taxanes-based regiment
* Existing emesis within 24 hours before chemotherapy administration
* Symptomatic brain metastasis or suspected clinical brain metastasis
* Serious uncontrolled systemic illness or medical condition: congestive heart failure, unstable angina, history of documented myocardial infarction within 6 months, uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious neurological or mental abnormalities including mental disorder, epileptic dementia, which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer or other contraindication for corticosteroid therapy.
* Inability to take or absorb oral medicine
* Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment
* Unsuitable for the study or other chemotherapy determined by investigator | 31,000 |
Study Objectives
This study is to investigate safety and feasibility of a combination therapy of a tumor infiltrating lymphocytes (TIL) transfer with anti-programmed cell death protein (PD)-1 therapy in patients with metastatic melanoma that failed immunotherapy.Tumor-infiltrating lymphocytes will be expanded from resected melanoma samples from the patient and expanded TILs will be transferred to the patient after non-myeloablative chemotherapy with cyclophosphamide and fludarabine. TIL transfer will be combined with low dose Interleukin (IL)-2 and nivolumab anti-PD-1 treatment.
The study uses a personalized Investigational Medicinal Product (IMP), i.e. TIL product and in combination with IL-2 treatment and nivolumab.
Conditions: Advanced Melanoma
Intervention / Treatment:
DRUG: Combination of TIL Transfer with anti-PD-1 Therapy and low dose IL-2
| Inclusion Criteria:
* Histologically confirmed unresectable or metastatic melanoma
* At least 1 PD-1 targeted immunotherapy and BRAF inhibition in case of BRAF mutated melanoma
* Resectable tumor mass and measurable disease by CT or MRI per RECIST 1.1 criteria (in addition to the resected lesion)
* World Health Organization (WHO) clinical performance Status (ECOG) 0-1
* Adequate organ function
* Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for five months after receiving the last dose of nivolumab for women and seven months for men
* Patients must be able to understand and sign the Informed consent document
* Hematology: Absolute neutrophil count greater than 1.5 x 109/L without support of filgrastim. Platelet count greater than 100 x 109/L. Hemoglobin greater than 5 mmol/L, or 80 g/L.
* Chemistry: Serum alanine aminotransferase (ALAT)/ aspartate transaminase (ASAT) less than 3 times the upper limit of normal, unless patients have liver metastases (< 5 times ULN). Serum creatinine clearance 50 ml/min or higher. Total Bilirubin less than or equal to 20 micromol/L, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 50 micromol/L. Lactate dehydrogenase (LDH) ≤ 2x ULN
* Serology: Seronegative for HIV antibody. Seronegative for hepatitis B antigen, and hepatitis C antibody. Seronegative for syphilis.
Exclusion Criteria:
* Life expectancy of less than three months
* Patients with metastatic ocular/ mucosal or other non-cutaneous melanoma.
* Requirement for immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to randomization
* Uncontrolled central nervous system (CNS) metastases. Controlled CNS metastases must be for at least 4 weeks stable.
* Documented Forced expiratory volume at one second (FEV1) less than or equal to 50% predicted for patients with:
* A prolonged history of cigarette smoking (greater than 20 pack/year within the past 2 years)
* Symptoms of respiratory distress
* All patients' toxicities due to prior non-systemic treatment must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures or focal palliative radiotherapy (to non-target lesions) within the past 4 weeks, as long as all toxicities have recovered to grade 1 or less.
* Women who are pregnant or breastfeeding, because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
* Any active systemic infections, coagulation disorders or other active major medical illnesses.
* Contraindication for IL-2 or nivolumab (allergies etc.).
* Any autoimmune disease: patients with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, autoimmune thyroiditis (e.g. Hashimoto's disease), autoimmune hepatitis, systemic progressive sclerosis (scleroderma), Systemic Lupus Erythematosus, autoimmune vasculitis (e.g., Wegener's Granulomatosis). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barré Syndrome) are excluded from this study. Patients with vitiligo are eligible to enter the study | 5,787 |
Study Objectives
The objective of the study is to demonstrate the safety, tolerability, and activity of Rituximab-Bendamustine-Cytarabine(R-BAC) regimen in patients with mantle cell lymphoma (MCL) aged 65 years or more, as well as in younger patients who are not eligible for intensive regimens including/not including autologous transplantation.
Conditions: Lymphoma, Mantle-Cell
Intervention / Treatment:
DRUG: Rituximab, Bendamustine, Cytarabine
| Inclusion Criteria:
* Previously untreated patients with MCL aged 65 years or more, or <65 years if not eligible for intensive treatments including/not including autologous transplantation.
* MCL patients of any age who relapse/progress or are resistant after one line of chemotherapy.
* CD20+ .
* Karnofsky score of at least 70%
* Adequate renal function (Creatinine clearance >40 mL/min), with preserved diuresis.
* Adequate liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN) value, total bilirubin <2 mg/dL, unless directly attributable to the patient's tumor.
* Negative serum pregnancy test 1 week prior to treatment both for pre-menopausal women and for women who are <2 years after onset of menopause.
* Hepatitis B core antibody (HBcAb) positive patients may be enrolled if correct antiviral prophylaxis is administered at least 2 weeks before initiating protocol treatment.
* Written informed consent.
Exclusion Criteria:
* Prior treatment with Bendamustine.
* Refractoriness to Rituximab, defined as progressive disease during a previous cycle including this drug, or relapse within 6 months to any previous cycle including Rituximab.
* Previous Rituximab infusion-related severe reactions.
* Human immunodeficiency virus (HIV) positive.
* Medical conditions or organ injuries that could interfere with administration of therapy.
* Active bacterial, viral, or fungal infection requiring systemic therapy.
* Seizure disorders requiring anticonvulsant therapy.
* Severe chronic obstructive pulmonary disease with hypoxaemia.
* History of severe cardiac disease: New York Heart Association (NYHA) functional class III-IV, myocardial infarction within 6 months, ventricular tachyarrhythmias, dilatative cardiomyopathy, or unstable angina.
* Uncontrolled diabetes mellitus.
* Active secondary malignancy.
* Known hypersensitivity or anaphylactic reactions to murine antibodies and proteins (for patients treated with Rituximab), to Bendamustine or mannitol.
* Fertile men and women of childbearing potential unless surgically sterile or using adequate measures of contraception.
* Major surgery within 4 weeks of study Day 1.
* HBsAg+ and HCV+ patients
* Any co-existing medical or psychological condition that would preclude participation in the study or compromise the patient's ability to give informed consent, or that may affect the interpretation of the results, or render the patient at high risk from treatment complications. | 27,284 |
Study Objectives
The purpose of this proposal is to develop and test the efficacy in a randomized, controlled clinical trial of an Oncology Nurse Care Management (ONCM) program to support cancer patients early in their course. The ONCM program will be compared with an Enhanced Usual Care (EUC) program that will provide education materials and treatment resources for patients. Efficacy will be measured by differences over time in participant-reported Quality of Life, Symptoms and Emotional Distress, and Quality of Care between patients receiving ONCM versus EUC.
Conditions: Cancer
Intervention / Treatment:
OTHER: Oncology Nurse Care Management, OTHER: Patient-centered materials
| Inclusion Criteria:
* On the panel of an eligible and consenting primary care physician;* Diagnosed with a new occurrence of breast (females only) , colorectal, or lung cancer within the past three weeks;* Age 18 or older; and* Able to complete the baseline questionnaire.
Exclusion Criteria:
* They plan to disenroll from GH or be out of the area in the coming year; or* Primary care physician or specialty physician expects survival to be less than 12 months; or* Don't speak English; or* Have moderate cognitive impairment (a score of 3 or more on a six-item validated instrument, or psychosis as assessed by ICD-9 codes from GH medical record data. | 24,060 |
Study Objectives
The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.
Conditions: Advanced Solid Tumor
Intervention / Treatment:
DRUG: LY3039478
| Inclusion Criteria:
* Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic.
* In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate.
* Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Adequate organ function, including hematologic, hepatic, and renal.
* Estimated life expectancy of ≥12 weeks.
Exclusion Criteria:
* Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively.
* Have serious preexisting medical conditions.
* Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea.
* Have an active bacterial, fungal, and/or known viral infection.
* Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results. | 24,715 |
Study Objectives
To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.
Conditions: Breast Cancer, Osteoporosis
Intervention / Treatment:
DRUG: Letrozole, DRUG: Zhongyaofufang, DRUG: Xianlinggubao
| Inclusion Criteria:
* Histologically confirmed invasive breast cancer;
* Post-surgery, primary lesion been removed;
* Post-Menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
* Histologically confirmed ER and/or PR positive ;
* Receiving adjuvant AIs therapy in the following one years;
* Leukocyte ≥ 3\*10(9)/L; Platelets ≥ 75\*10(9)/L;
* Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal range;
* Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range;
* Written informed consent according to the local ethics committee equirements;
Exclusion Criteria:
* Metastatic Breast Cancer;
* Received Neo-Adjuvant Endocrine Therapy;
* History of pelvic fracture or bone metabolic disease;
* Received drugs interfering bone metabolism in the last 12 months;
* Baseline Bone Mineral Density: T < -2SD;
* With other primary malignant disease;
* With severe non-malignant co-morbidity that will influence long-term follow up;
* Known severe hypersensitivity to any drugs in this study; | 30,624 |
Study Objectives
This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI \>25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.
Conditions: Prostate Cancer
Intervention / Treatment:
OTHER: Carbohydrate restricted diet, OTHER: Non-restricted diet, OTHER: Phone counseling with dietitian
| Inclusion Criteria:
* Pathologically confirmed prostate adenocarcinoma
* Most recent biopsy positive for prostate cancer
* Currently on or starting active surveillance
* Ability to read, write, and understand English
* BMI >24 kg/m2
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
* Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer
* Age > 18 years
Exclusion Criteria:
* Already consuming a severely carbohydrate-restricted (i.e. <20g total carbohydrates per day) or vegetarian diet
* Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
* Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy)
* Loss of >10% of body weight within the previous 6 months
* Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide)
* If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications)
* Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge)
* Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program | 1,060 |
Study Objectives
The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients
Conditions: Barrett's Esophagus
Intervention / Treatment:
DRUG: Esomeprazole, DRUG: Lansoprazole
| Inclusion Criteria:
* Documented history (within 2 yrs of histologically proven BE;
* Aged 18-70 (inclusive);
* Willing and able to comply with all study procedures
Exclusion Criteria:
* Signs of clinically significant GI bleeding within 3 days prior to randomization;
* History of gastric or esophageal surgery;
* Clinically significant illness within 2 weeks prior to first dose of study drug or during study | 30,510 |
Study Objectives
The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9vHPV vaccine. No hypothesis will be tested since this study is an estimation-only study.
Conditions: Papillomavirus Infections
Intervention / Treatment:
BIOLOGICAL: 9vHPV vaccine
| Inclusion Criteria:
* Is Japanese male or female.
* Is aged at the time of providing the documented informed consent (inclusive): (3-dose boy arm) male from 9 years to 15 years old, (2-dose boy arm) male from 9 years to 14 years old, or (2-dose girl arm) female from 9 years to 14 years old.
* Has a legally acceptable representative who can read, understand and complete the vaccination report card (VRC).
* Has not yet had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7.
Exclusion Criteria:
* Has a fever (defined as oral temperature ≥37.5°C) within the 24-hour period prior to the Day 1 visit.
* Has a history of severe allergic reaction that required medical intervention.
* Is allergic to any vaccine component, including aluminum, yeast, or Benzonase™.
* Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
* Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other auto immune condition.
* Has a history of splenectomy.
* Has a history of genital warts or positive test for human papillomavirus (HPV).
* Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within 12 months) of drug or alcohol abuse or dependence at the discretion of the investigator. .
* Has received within 12 months prior to enrollment, is receiving, or plans to receive during Day 1 through Month 7 of the study, any study-prohibited concomitant immunosuppressive therapy .
* Has received within the 3 months prior to the Day 1 vaccination, is receiving, or plans to receive during Day 1 through Month 7 of the study, any immune globulin product or blood-derived product other than intravenous gamma globulin (IVIG).
* Has received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 28 days prior to Day 1 vaccination.
* Has previously received a marketed HPV vaccine or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo).
* Is concurrently enrolled in other clinical studies of investigational agents.
* Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled.
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study. | 27,387 |
Study Objectives
While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.
Conditions: Endometrial Cancer, Endometrial Neoplasms, Endometrial Adenocarcinoma, Endometrial Cancer Stage I, Endometrial Cancer Stage II, Endometrial Endometrioid Adenocarcinoma, Sentinel Lymph Node, Hysterectomy, Laparoscopic Hysterectomy
Intervention / Treatment:
PROCEDURE: Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy
| Inclusion Criteria:
* Age ≥18 years
* Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2)
* FIGO stage IA
* FIGO stage IB and II when LND is contraindicated
* No contraindications for surgery
* Signed informed consent
Exclusion Criteria:
* * Age <18 years
* Presence of tumor spread outside the corpus uteri
* Absence of tumor invasion into the myometrium
* High-grade tumor (G3)
* Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)
* Preoperative treatment of endometrial cancer including radiotherapy, systemic chemotherapy, or hormone therapy
* Prior pelvic or retroperitoneal LND
* History of surgeries on the uterus and uterine appendages, with exceptions such as cesarean section, tubectomy, oophorectomy, ovarian resection, ovarian biopsy, and ovarian cauterization
* Allergy to iodine-containing drugs
* Contraindications to surgical treatment
* Lack of signed informed consent | 6,956 |
Study Objectives
This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) who had experienced disease progression after platinum-containing systemic therapy. Participants were assigned randomly to receive either pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel 75 mg/m\^2 Q3W. The total number of participants randomized depended upon demonstration of sufficient objective responses at an interim analysis.
Eligible participants who were allocated to the first course of pembrolizumab (2 mg/kg Q3W or 10 mg/kg Q3W) and experienced disease progression, to be permitted to receive a second course of pembrolizumab as long as Inclusion/Exclusion criteria were met.
Protocol Amendment 12 (effective date: 09 Dec 2015) enabled eligible participants who were allocated to docetaxel and experienced disease progression, to be permitted to switch over to receive pembrolizumab 2 mg/kg Q3W as long as Inclusion/Exclusion criteria were met.
With Protocol Amendment 15 (effective date: 03 Jan 2018), all second course and switch over participants will receive pembrolizumab 200 mg Q3W. Response or progression during the second and switch over pembrolizumab courses will not count towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses will not count towards safety outcome measures.
Also with Amendment 15, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and enrolled in an extension study (Keynote 587; NCT03486873) to continue protocol-defined assessments and treatment. Switch over participants who have not transitioned to pembrolizumab will be considered for the extension study on a case-by-case basis.
The primary study hypotheses are that pembolizumab prolongs Overall Survival (OS) and Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by independent radiologists' review in previously-treated participants with NSCLC in the strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to docetaxel and in participants whose tumors express PD-L1 compared to docetaxel.
Conditions: Non Small Cell Lung Cancer (NSCLC)
Intervention / Treatment:
BIOLOGICAL: Pembrolizumab, DRUG: Docetaxel
| Inclusion Criteria:
* Life expectancy of at least 3 months
* Histologically- or cytologically-confirmed diagnosis of NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive per central laboratory review
* At least one bi-dimensional measurable lesion
* Radiographic progression after treatment with at least 2 cycles of a platinum-containing doublet
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
* Prior therapy with docetaxel for NSCLC
* Receiving systemic steroid therapy within 3 days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication
* Currently participating or has participated in a study using an investigational antineoplastic agent or device within 30 days of first dose
* Expected to require any other form of systemic or localized antineoplastic therapy while on trial
* History of allogeneic tissue/solid organ transplant
* Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of study drug; received thoracic radiation therapy of >30 Gy within 6 months of the first dose of study drug; received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within 7 days of the first dose of study drug
* Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor 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), or took part in another pembrolizumab trial
* Known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
* Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment
* Known history or active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after last dose of pembrolizumab or 180 days after last dose of docetaxel | 15,041 |
Study Objectives
The study, investigates the current physical activity promotion practices among physicians and nurses, as well as social norms toward physical activity during treatment among cancer patients and among physicians and nurses who treat or counsel cancer patients.
Conditions: Colorectal Cancer, Breast Cancer, Prostate Cancer, Physicians, Nurses
Intervention / Treatment:
| Inclusion Criteria:
* HCP are eligible if they meet the following inclusion criteria: Working as an oncological nurse, general practitioner or physician specialized in oncology, radiology, surgery, gynecology, urology, gastroenterology or rehabilitation Signed informed consent
* Patients are eligible if they meet the following inclusion criteria: Patients with a diagnosis of primary tumor or recurrence no longer than 2 years ago who are undergoing chemo- or radiotherapy currently or in the last 2 years Patients undergoing chemo- or radiotherapy currently or no longer than 2 years ago At least 18 years of age Sufficient German language skills Signed informed consent
Exclusion Criteria:
* HCP will be excluded from the trial if they meet the following exclusion criteria: No regular contact with cancer patients
* Patients will be excluded from the trial if they meet the following exclusion criteria: Presence of comorbidities that preclude involvement in exercise programs (e.g. severe pain, advanced heart failure \[≥ NYHA III\]) Mentally retarded Reduced standing ability and no ability to walk | 21,541 |
Study Objectives
A Phase I, Open-Label, Two Parts Study to Assess the Safety, Tolerability,Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Chinese Patients with Advanced Non-Small Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent
Study Objective: 1, Primary Objective To characterise the pharmacokinetics (PK) of AZD9291 and its metabolites (AZ5104 and AZ7550) after single then multiple doses of AZD9291 administered orally once daily in Chinese patients with locally advanced or metastatic non small cell lung Cancer (NSCLC) who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) agent.
2, Secondary objective(s) To investigate the safety and tolerability of AZD9291 when given orally to Chinese patients with locally advanced or metastatic NSCLC who have progressed following prior therapy with an approved EGFR TKI agent. To obtain a preliminary assessment of the anti-tumour activity of AZD9291 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Conditions: Carcinoma, Non-Small-Cell Lung With EGFR Mutation Positive
Intervention / Treatment:
DRUG: AZD9291 40 mg, DRUG: AZD9291 80 mg
| Inclusion Criteria:
* Provision informed consent* Aged at least 18 years* Histological or cytological confirmation diagnosis of NSCLC* Locally advanced or metastatic NSCLC* Radiological documentation of disease progression while on a previous continuous treatment with an approved EGFR TKI. In addition other lines of therapy may have been given
* Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)* World Health Organisation (WHO) performance status 0-1* At least one lesion suitable for accurate repeated measurements* Females
* Child bearing potential : should not be breast feeding, use adequate contraceptive measures for female patients with child-bearing potential, OR
* Have evidence of non-child-bearing potential that meet one of the following criteria at screening:
* Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
* Women below 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution
* Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation* Male patients should be willing to use barrier contraception ie, condoms
Exclusion Criteria:
* Treatment with any of the following (prior to first dose of study treatment)
* Treatment with an EGFR TKI within 8 days
* Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days
* Previous treatment with AZD9291, or a Thr790Met (T790M) directed EGFR TKIs
* Major surgery (excluding placement of vascular access) within 4 weeks
* Radiotherapy :
* Within 1 week if limited field of radiation for palliation of the first dose of study treatment
* Within 4 weeks if receiving radiation to more than 30% of the bone marrow or with a wide field of radiation
* Patients currently receiving (or unable to stop use at least 1 week) medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A4)
* Treatment with an investigational drug within five half-lives of the compound* Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy* Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required* Any of the following cardiac criteria:
* Mean resting corrected QT interval (QTc) >470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derivedQTc value
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block, second degree heart block, P wave to R wave (PR) interval >250 msec
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long (Q-T interval) QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease 7, Inadequate bone marrow reserve or organs function as demonstrated by any of the following laboratory values:
* Absolute neutrophil count <1.5x109/L
* Platelet count <100x109/L
* Hemoglobin <90 g/L
* Alanine aminotransferase >2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases
* Aspartate aminotransferase >2.5 times ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases
* Total bilirubin >1.5 times ULN if no liver metastases or >3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases
* Creatinine >1.5 times ULN concurrent with creatinine
8, Clearance <50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9291 9, History of hypersensitivity to active or inactive excipients of AZD9291 or drugs with a similar chemical structure or class to AZD9291 10, Women who are breast feeding 11, Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the study site) 12, Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements | 11,204 |
Study Objectives
Background: Psychological burden in cancer patients may worsen quality of life and even medical outcomes such as mortality. Nevertheless, many distressed patients are not recognized by the treating clinicians and left untreated even though effective psychosocial interventions exist. Existing screenings programs have multiple limitations such as the necessity of time consuming training and involvement of clincial staff, conventional screening instruments with limited diagnostic accuracy and the focusing on objective measures of distress, thereby neglecting subjective supportive care needs.
Aims: To address some of the limitations outlined above, we developed an electronic psycho-oncological adaptive screening program (EPAS) which separately assesses distress and psychosocial care needs and provides immediate patient feedback with individualized recommendations about psychosocial care services.
Design: Patients of the intervention are compared to a control condition. All participants are assessed at three measurement points (baseline, and at 3-months and 6-months follow-up).
Outcomes: Outcomes assess aspects related to psychosocial care services, well-being and satisfaction.
Recruitment: Patients are recruited within suitable health care facilities within the University Cancer Center Hamburg (UCCH) and other facilities in the competence network of the UCCH. Patients are checked for eligibility via review of the medical chart and consecutively recruited by research assistants.
Duration of the study: From start of recruitment, 2 years are planned until data analysis. 1 year is planned for recruitment.
Analyses: We conduct group comparisons in the study outcomes, both unconditional and condcitional (controlled for care relevant co-variates).
Conditions: Cancer
Intervention / Treatment:
BEHAVIORAL: EPAS (electronic psycho-oncological adapative screening program)
| Inclusion Criteria:
* minimum age of 18 years
* diagnosed with any malignancy according to ICD-10 (first diagnosis or relapse)
Exclusion Criteria:
* Patients with any impairments interfering with the ability to give informed consent | 22,510 |
Study Objectives
Radical cystectomy with urinary diversion is associated with substantial perioperative morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional decline. Post-operative morbidity after cystectomy prolongs the length of stay, increases the risk of readmission, and adds substantially to health care costs. Protocols that emphasize early and frequent ambulation after surgery decreases post-operative morbidity, but poor patient adherence diminishes the effectiveness of these protocols, which are currently implemented only during the hospital stay. Financial incentives overcome present bias and offer a novel and practical approach to increasing ambulation during the post-operative period in the hospital and also after discharge. This application proposes a pilot randomized, controlled trial to estimate the effect size of financial incentives on achieving a patient-specific daily step goal in the hospital and post-discharge for 1 month following radical cystectomy. Secondary outcomes include step count, composite morbidity, and functional decline. Forty-six adults with bladder cancer undergoing radical cystectomy at the Hospital of the University of Pennsylvania will be randomized to either control (education of step goal with monitoring and daily feedback) or a gain financial incentive combined with a lottery incentive if they achieve 75% of the daily goals during the study period. Fitbit Zips will be used to measure step counts for all participants. This proposal will provide the preliminary data needed to design future, larger trials that will test the effect of financial incentives to increase ambulation on post operative complications, readmissions, and functional decline.
Conditions: Bladder Cancer
Intervention / Treatment:
OTHER: Financial Incentive to Increase Ambulation
| Inclusion Criteria:
* Planning to undergo radical cystectomy (either with ileal conduit, Indiana pouch, neobladder (e.g., Studer or Hautmann pouch) at the University of Pennsylvania
* Patient has been diagnosed with bladder cancer
* Patient is at least 21 years of age
* Patient is ambulatory with baseline ECOG performance status less than or equal to 2
Exclusion Criteria:
* Patient knows he or she will be unable or unwilling to use a mobile device and online tool to upload activity data
* Poor preoperative performance status (ECOG 3 or greater)
* Plan for cystectomy without cutaneous ureterostomies (without a bowel diversion)
* Non-English speakers
* Patient is non-ambulatory
* Patient is incapable of consenting himself or herself prior to surgery (Because participating in this trial involves ongoing effort on the part of the subject, patients who are incapable of consenting for themselves at baseline are excluded)
* Patients who do not have at least 24 hours of pre-operation ambulation data | 6,662 |
Study Objectives
This is a pilot study to evaluate the feasibility of, adherence to, and early efficacy of Band Together, a strength-training and walking program (intervention arm) vs. education on the benefits of exercise (control arm) in patients with aggressive gastrointestinal (GI) malignancies (gastric, gastroesophageal, and pancreatic cancer) undergoing neoadjuvant therapy.
Conditions: Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction
Intervention / Treatment:
BEHAVIORAL: Band Together, OTHER: Exercise Education
| Inclusion Criteria:
* Age 18 years or older* New diagnosis of potentially resectable or borderline resectable pancreatic adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction.* Patients must be evaluated at the Penn State Hershey Medical Center prior to receiving neoadjuvant chemotherapy or chemoradiation.* Patients must be deemed appropriate for neoadjuvant therapy by their treating health care providers.* The ability to speak and read English.* The ability to provide informed consent.
Exclusion Criteria:
* Angina (stable or unstable)* Paraplegia or quadriplegia* Joint or muscle conditions that prevent the patient from being able to grip and or lift resistance bands.* Patients who have already started neoadjuvant chemotherapy at other institutions.* Presence of metastatic disease.* Gastric or pancreatic histologies other than adenocarcinoma.* Pregnant women.* Prisoners* Patients screening positive on the Physical Activity Readiness Questionnaire (PAR-Q) | 7,893 |
Study Objectives
The Evaluating Cancer Survivorship Care Models project is an innovative 3-year study that is collecting data to help understand how to best deliver follow-up care to cancer survivors. Cancer is a complex disease requiring complex treatments that can cause lasting impacts after treatment ends. Some patients face physical, psychosocial, spiritual and/or practical challenges as they adjust to life after cancer. Fortunately, health care providers have begun to focus on the consequences of cancer and its treatment and are more actively working with cancer survivors to manage post-treatment needs and care.
Led by the George Washington University and funded by the Patient-Centered Outcomes Research Institute, this project brings together representatives from the Commission on Cancer, the Cancer Support Community, LIVESTRONG and the American Cancer Society as well as cancer survivors and healthcare professionals to better understand how different strategies or models of care impact outcomes that are most important to cancer survivors. The project will focus on survivors of breast, prostate and colorectal cancers and will be relevant for understanding the needs and preferences of survivors of other cancers as well. The emphasis is on patient-centered outcomes, which are outcomes that are most significant to patients, such as patient satisfaction and quality of life.
Conditions: Quality of Life, Cancer
Intervention / Treatment:
OTHER: Organizational Interview, OTHER: Organizational Survey, OTHER: Survivor Survey (1): Pre-Visit Baseline, OTHER: Survivor Survey (2): Post-Visit, OTHER: Survivor Survey (3): 3 Month Post-Visit, OTHER: Survivor Survey (4): 6 Month Post-Visit, OTHER: Clinician Survey
| Inclusion criteria for the CER component:
Survivorship program administrators oversee survivorship programs which:
* See at least 60 new survivors of non-metastatic breast, prostate or colorectal cancer or survivors of any type of cancer yearly
* Represent one of the clinical survivorship care models identified in our environmental scan
* Indicate a high performance level on incorporating elements of survivorship care into clinical care delivery.
Survivors:
* English-speaking survivors of non-metastatic breast, prostate or colorectal cancers
* Completed planned active treatment (chemotherapy, radiation, and/or surgery) with the exception of hormonal medication, aromatase inhibitors or other maintenance therapy
* Diagnosed at 18 years old or older
* First appointment with the survivorship program is planned but has not yet been completed
Survivorship program clinicians:
* Must be providing services for eligible survivors who have completed their first visit with the survivorship program and are participating in the study.
Exclusion criteria for the CER component:
Survivorship program administrators:
* Programs with fewer than at least 60 new survivors yearly
* Do not provide services to adult survivors of non-metastatic breast, prostate or colorectal cancer or survivors of any type of cancer
* Do not represent one of the three models of clinical survivorship care as identified in our environmental scan
* Do not indicate a high performance level on incorporating elements of survivorship care into clinical care delivery
Survivors:
* Received diagnosis for cancer that was not breast, prostate or colorectal cancer
* Not English-speaking
* Currently undergoing active treatment (defined as chemotherapy, radiation, and/or surgery)
* Cancer has metastasized
* Diagnosed at under 18 years old
* Have completed first appointment with the survivorship program
Men will be excluded from the breast cancer arm of the study. Women will be excluded from the prostate cancer arm of the study.
Survivorship program clinicians:
* Not providing services for eligible survivors. | 10,050 |
Study Objectives
This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously once a week. The eligible patient population will be patients with advanced solid tumors.
The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety data will be evaluated as secondary objectives.
Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced solid tumors.
Dose escalation will be guided by a Bayesian logistic regression model with over dose control (EWOC) using at least 2 patients per dose cohorts.
Safety criteria will be followed, including adverse events according to Common Terminology Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination, vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).
Conditions: Neoplasms
Intervention / Treatment:
DRUG: BI 836880
| Inclusion criteria:
1 Age >=18 years 2. Histologically confirmed malignancy which is locally advanced or metastatic solid tumor, and either refractory after standard therapy for the disease or for which standard therapy is not reliably effective e.g. patients do not tolerate or have contraindications to otherwise available standard therapy and tumour lesions evaluable for Dynamic contrast-enhanced (DCE)-MRI at MTD.
* ECOG performance status <= 2 4. Adequate hepatic, renal and bone marrow functions as defined by the following criteria:
* Total bilirubin within normal limits (<= 1.5x upper limit of normal (ULN) for patient with Gilberts syndrome)* Alanine amino transferase (ALT) and aspartate amino transferase (AST) <= 1.5x ULN (< 5x upper limit of normal (ULN) for patient known liver metastases)* Serum creatinine < 1.5x ULN* International normalized Ratio (INR) 0.8-1.2 or partial thromboplastin time (PTT) < 1.5x ULN* Absolute neutrophil count (ANC) > 1.5 109/L* Platelet count > 100x109/ L.* Haemoglobin > 10 g/dl (without transfusion within previous week) 5. Signed and dated written informed consent. 6. Life expectancy >= 3 months in the opinion of the investigator 7. Recovery from all reversible adverse events of previous anti-cancer therapies to baseline or CTCAE grade1, except for alopecia (any grade), sensory peripheral neuropathy CTCAE grade <= 2 or considered by the investigator as clinically not significant.
8. Male or female patients. Women of childbearing potential\* must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation \[ICH M3(R2)\] in combination with male condom as "double barrier", during the trial and for at least 6 months after the end of treatment with BI 836880, that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Male patient must always use condoms when sexually active during the trial and for at least 6 months after the end of treatment with BI 836880.
\*Women of childbearing potential are defined as: Any female who has experienced menarche and does not meet the criteria for "women not of childbearing potential" as described below.
Women not of childbearing potential are defined as:
Women who are postmenopausal (12 months with no menses without an alternative medical cause) or who are permanently sterilized (e.g., hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
Exclusion criteria:
1. Known hypersensitivity to the trial drugs or their excipients or risk of allergic of anaphylactic reaction to the study drug according to the investigator judgement (e.g. patient with history of anaphylactic reaction or autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDS), inhaled corticosteroids, or the equivalent of < 10 mg/day prednisone)
2. Current or prior treatment with any systemic anti-cancer therapy either within 28 days or a minimum of 5 half-lives, whichever is shorter at the start of study treatment.
3. Serious concomitant disease (based on investigator judgement), especially those affecting compliance with trial requirements or which are considered relevant for the evaluation of the endpoints of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial.
4. Major injuries and/or surgery (as judged by the investigator) or bone fracture within 4 weeks of start of study treatment, or planned surgical procedures during the trial period.
5. Patients with personal or family history of QT prolongation and/or long QT syndrome, or prolonged QT interval corrected for heart rate according to Fridericia's formula (QTcF) at baseline (> 470 ms). QTcF will be calculated by Investigator as the mean of the 3 ECGs taken at screening.
6. Significant cardiovascular/ cerebrovascular disease (i.e uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure > New York heart association ( NYHA II). Uncontrolled hypertension defined as: blood pressure in tested and relaxed condition >= 140 mmHg, systolic or > 90 mmHg diastolic (with or without medication), measured according to Section 5.3.2 and Appendix 10.2.
7. History of severe haemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis).
8. Known inherited predisposition to bleeding or to thrombosis in the opinion of the investigator.
9. Patient with brain metastases that are symptomatic and/or require therapy.
10. Patients who require full-dose anticoagulation (according to local guidelines). No vitamin K antagonist and other anticoagulation allowed; low-molecular-weight heparin (LMWH) allowed only for prevention not for curative treatment.
11. Use of alcohol or drug incompatible with patient participation in the study in the investigator opinion
12. Patient unable or unwilling to comply with protocol
13. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
14. Previous enrolment in this trial | 33,817 |
Study Objectives
CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.
Conditions: Melanoma and Metastatic Colorectal Cancer
Intervention / Treatment:
DRUG: LGX818
| Inclusion Criteria:
For the dose escalation phase:
* Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer \[AJCC\]). For the dose expansion phase: (i) Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer \[AJCC\]), or (ii) confirmed diagnosis and non-resectable advanced metastatic colorectal cancer (mCRC) for which no further effective standard therapy exists.* Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.* Evidence of measurable disease
Exclusion Criteria:
* Previous therapy with a MEK inhibitor.* Symptomatic or untreated leptomeningeal disease.* Symptomatic or untreated brain metastasis.Patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging.* Known acute or chronic pancreatitis.* Clinically significant cardiac disease* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818* Previous or concurrent malignancy. Exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).* History of thromboembolic or cerebrovascular events within the last 6 months
Other protocol-defined inclusion/exclusion criteria may apply | 35,278 |
Study Objectives
This is a phase 2 study of investigational drug, durvalumab given in combination with azacitidine (CC-486). The main purpose of this phase 2 study is to assess the antitumor activity of azacitidine in combination with durvalumab patients with microsatellite stable colorectal carcinoma (MSS-CRC), platinum resistant epithelial ovarian cancer type II (PR-OC), and estrogen receptor positive and HER2 negative breast cancer.
Conditions: Microsatellite Stable Colorectal Carcinoma, Platinum Resistant Epithelial Ovarian Cancer Type II, Estrogen Receptor Positive and HER2 Negative Breast Cancer
Intervention / Treatment:
DRUG: Azacitidine, DRUG: Durvalumab
| Inclusion Criteria:
* Able to provide written informed consent.
* Age ≥18 years or ≥20 years for Japanese participants.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of ≥12 weeks
* Have histologically or cytologically-documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the patient and treating physician.
* Have one of the following advanced (unresectable and/or metastatic) solid tumor indications:
* Microsatellite Stable Colorectal Carcinoma (MSS-CRC)
* Platinum Resistant Epithelial Ovarian Cancer Type II (PR-OC)
* Estrogen Receptor Positive and HER2 Negative Breast Cancer (ER+/HER2- BC):
* The following considerations will be made regarding prior treatment regimens:
* MSS-CRC: must have progressed or be intolerant of 5-FU, irinotecan, oxaliplatin and epidermal growth factor receptor (EGFR) mAb in patients with RAS wild type tumors, in recurrent/metastatic setting.
* PR-OC: must have progressed on at least 1, maximum of 2 lines of cytotoxic agents in the platinum resistant disease setting
* ER+/HER2- BC: must have progressed on at least 2, maximum of 5 lines of cytotoxic agents in recurrent/metastatic setting.
* Adequate normal organ and marrow function
* Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
* At least one measurable lesion according to RECIST v1.1.
* At least one lesion safely accessible for biopsy.
* Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
* Consent to provide archival tumor tissue (initial and subsequent tumor biopsy samples, if possible) for correlative biomarker studies, if available.
* Female subject of childbearing potential1 should have two negative pregnancy tests as verified by the investigator prior to starting any investigational product therapy
* Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to practice true abstinence or use at least two effective methods of contraception for the study defined period.
* Non-sterilized males who are sexually active with a female partner of childbearing potential must agree to use at least two effective methods of contraception for the study defined period.
Exclusion Criteria:
* Involvement in the planning and/or conduct of the study or previous enrolment in the present study.
* Participation in another clinical study with an investigational product during the last 28 days or 5 half-lives prior to study Day 1. Concurrent enrolment in an observational (noninterventional) clinical study or the follow-up period of an interventional study is allowed.
* Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab. Prior anti-CTLA4 agents are allowed. Prior therapy with T-cell co-stimulatory agents (e.g. anti-CD137 antibody, anti-OX40 antibody) are allowed.
* Prior therapy with CC-486, azacitidine, decitabine or any other hypomethylating agent.
* History of another primary malignancy with exceptions.
* Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 28 days prior to the first dose of study drug (and within 6 weeks for nitrosourea or mitomycin C).
* Mean QT interval corrected for heart rate (QTc) ≥470 ms.
* Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab with exceptions.
* Any unresolved toxicity CTCAE grade 2 from previous anti-cancer therapy.
* Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1, with exception of chronic endocrinopathy that is stable on hormone replacement.
* Active or prior documented autoimmune disease within the past 2 years.
* Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
* History of primary immunodeficiency
* History of allogeneic organ transplant
* History of hypersensitivity to study drug formulations, including azacitidine, mannitol, or durvalumab, its constituents, or to any other humanized monoclonal antibody
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
* Known history of previous clinical diagnosis of tuberculosis
* Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of investigational products.
* Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
* Irritable bowel syndrome or other serious gastrointestinal chronic conditions associated with diarrhea within the past 3 years prior to the start of treatment, and/or history of prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the investigational product and/or predispose the patient to an increased risk of gastrointestinal toxicity.
* Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
* Patients with uncontrolled seizures.
* Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment with the exception of patients on adjuvant endocrine therapy for a history of non-invasive breast cancer.
* Major surgery within 28 days prior to Day 1 of the study or still recovering from prior surgery.
* Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
* Patients who are involuntarily incarcerated or are unable to willingly provide consent or are unable to comply with the protocol procedures. | 33,445 |
Study Objectives
The investigational product (IP) HL-085 is an adenosine triphosphate-noncompetitive mitogen activated protein kinase (MEK) inhibitor with a strong selective anti-tumor activity, with a much lower dose than selumetinib. It has been shown strong anti-tumor activities in preclinical studies to treat solid tumors, e.g., melanoma, non-small cell lung cancer, colon cancer and other malignancies with RAF and RAS mutations.
Kechow has completed phase I dose escalation study to test HL-085 in patients with advanced NRAS mutated melanoma in China. The tested doses were 0.5 mg, 1mg, 2mg, 3mg, 4mg, 6mg, 9mg, 12mg, 15mg and 18mg BID oral administration and there was no dose-limiting toxicity (DLT) identified. All patients tolerated the study drug reasonably well.
This study is a Phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetic (PK) and preliminary antitumor activities of HL-085 in US patients with advanced solid tumors. The objective of the dose escalation is to evaluate safety and tolerability of selected TID and BID dose regimens in US patient population with advanced solid tumor and establish the Recommended Phase 2 Dose (RP2D).
The starting dose for this trial is 12 mg daily oral administration. Three selected daily doses - 12 mg (4mg TID, 6mg BID), 18 mg (6mg TID, 9 mg BID), and 24 mg (8 mg TID, 12 mg BID) will be tested in this study to assess safety and tolerability of HL-085 at the 3 selected dose levels in US patient population with advanced solid tumors.
Conditions: Solid Tumor, Adult
Intervention / Treatment:
DRUG: HL-085
| Inclusion Criteria:
* Written informed consent must be obtained prior to any clinical trial procedures* Aged 18 years or over.* Must have a pathologically documented solid tumor(s) that has relapsed from, or is refractory to standard treatment, or unable to tolerate toxicities from the SOC/available treatments, or for which no standard treatment is available.* Must have at least one measurable lesion as defined by RECISTv1.1 criteria for solid tumors.* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.* Life expectancy ≥3 months (as judged by the Investigator).* Must have adequate hematologic function (no blood transfusion and growth factor support for ≥14 days), adequate hepatic and renal function, and some key lab test results meeting the following laboratory values within 7 (+/-2) days before first dosing.* Must have the willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
Exclusion Criteria:
* Have biological, chemotherapy, immunotherapy or radiotherapy less than 4 weeks prior to starting the study treatment.* Have undergone or plan to have major surgery (except for tumor biopsy) or experienced severe trauma ≤28 days prior to starting the study treatment.* Have active central nervous system lesion (i.e., imaging instability and neurologically unstable). Note: patients who have received stereotactic radiotherapy or surgical treatment for brain tumor can be included after 3 months of procedure without symptoms.* Previous or history of second malignancy within 3 years prior to study treatment except for curatively treated.* Prior therapy with MEK-inhibitor with severe toxicity causing permanent damage from it, such as ocular, cardiac, pulmonary, etc. disorders and illness.* History of any of the following within 6 months prior to Screening:
* Myocardial infarction.
* Unstable angina.
* Coronary artery bypass graft.
* Coronary angioplasty or stenting.
* Chronic heart failure (New York Heart Association Grade ≥2).
* Ventricular arrhythmias requiring continuous therapy.
* Supraventricular arrhythmias, including atrial fibrillation, which are uncontrolled.
* Uncontrolled hypertension despite optimal medication management (per Investigator's assessment)
* Cerebrovascular accidents including transient ischemic attack, or pulmonary embolism.
* Creatine Phosphokinase (CPK) >2.5×ULN due to underlying cardiac disorders or myocardial infarction.* Mean resting QT calculated using Bazzetts formula (QTcB) ≥480 obtained from three electrocardiograms (ECGs); or family or personal history of long or short QT syndrome; Brugada syndrome or known history of QTc prolongation or Torsade de Pointes within 12 months of Screening.* Left ventricular ejection fraction (LVEF) <50%.* History or current evidence of retinal diseases (e.g., retinal vein occlusion \[RVO\] or retinal pigment epithelial detachment, macular degeneration, and retinal detachment).* Active/chronic infection with hepatitis C (note: patients positive for anti hepatitis C virus \[HCV\] antibody will be eligible if they are negative for HCV-ribonucleic acid \[HCV-RNA\]); or active hepatitis B, or active/chronic infection with human immunodeficiency virus (HIV).* Known active tuberculosis.* Infectious diseases requiring systemic treatment including patients tested positive for COVID-19 according to investigator site/institution's COVID-19 management policies and guidelines.* History of allogeneic bone marrow transplantation or organ transplantation.* Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention). Patients with subclinical pneumonitis who have received immunotherapy previously can be included if his/her condition is stable without any medical intervention.* Known hypersensitivity to IP ingredients or their analogues.* Unable to swallow IP or has refractory nausea and vomiting, malabsorption, external biliary diversion, or any significant small bowel resection that may interfere with adequate absorption of IP.* Concomitant medication which are strong inducers or strong inhibitors of cytochrome P450 CYP2C9, CYP2C19, CYP 3A4.* Pregnant or breast-feeding females.* Female patients of child-bearing potential or male patients who will not use an effective form of contraception for the duration of the study (until at least 30 days after the last dose of study medication). | 37,628 |
Study Objectives
This study evaluates the ability of a prototype intraoperative handheld gamma camera (pIHGC) to image (detect) sentinel lymph nodes (SLNs) in melanoma and breast cancer during surgical excision, as compared to standard of care intraoperative gamma probes (GP). The unit of study in this trial was SNLs rather individual participants. Each device was assessed for relative node detection sensitivity (S) of those SLNs.
Conditions: Multiple Myeloma, Breast Cancer
Intervention / Treatment:
DEVICE: Prototype intraoperative handheld gamma camera (pIHGC), DEVICE: Lymphoscintigraphy with intraoperative gamma probes (GP), RADIATION: radioactive Tc99M
| INCLUSION CRITERIA
* Malignancy for which sentinel node biopsy with lymphoscintigraphy are indicated as part of the standard of care for tumor staging
* Age 18 or greater.
* Healthy enough for surgery
* Able to understand and willing to sign a written informed consent document.
EXCLUSION CRITERIA
* No exclusion requirements due to co-morbid disease or intercurrent illness.
* Documented allergy to colloid.
* Lymphoscintigraphy presents excessive high risk, eg, a consideration if pregnant or lactating | 15,258 |
Study Objectives
The study protocol is based on a multi-center semi-quantitative approach of EUS elastography data in combination with contrast-enhanced EUS, consisting of measuring SR and SH for focal pancreatic masses and lymph nodes, as well as several parameters of CE-EUS based on time-intensity-curve (TIC) analysis. A number of parameters must be taken into consideration, as the ROIs are still manually selected by the user. The aim of the study is to establish an EUS based diagnostic algorithm in patients with pancreatic masses and lymph nodes, with negative or inconclusive cytopathology after EUS-FNA, based on previously published results and cut-offs of elastography and contrast-enhancement. The proposed algorithm of sequential use of real-time elastography, followed by contrast-enhanced EUS could be a good clinical tool to help select the patients with possible pancreatic adenocarcinoma or malignant lymph nodes, in the setting of patients with negative EUS-FNA results.
Conditions: Pancreatic Cancer, Secondary Malignant Neoplasm of Lymph Node, Benign Neoplasm of Lymph Nodes, Benign Pancreatic Tumors
Intervention / Treatment:
OTHER: Elastography, contrast enhancement
| Inclusion Criteria:
* Patients diagnosed with solid pancreatic tumor masses, with cytological / histo-logical confirmation
* Patients with or without suspected lymph node involvement are eligible
* Age 18 to 90 years old, men or women
* Signed informed consent for EG-EUS, CE-EUS and FNA biopsy
Exclusion Criteria:
* Prior surgical treatment with curative intent or chemo-radiotherapy
* Patients diagnosed with mucin producing tumors, pancreatic cystic tumors, etc. | 23,702 |
Study Objectives
The purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.
Conditions: Endometrial Cancer
Intervention / Treatment:
PROCEDURE: Sonohysterography
| Inclusion Criteria:
* Newly diagnosed early-stage endometrial cancer
Exclusion Criteria:
* Recurrent or persistent endometrial cancer
* Evidence of distant metastases | 3,588 |
Study Objectives
This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Herceptin, DRUG: Docetaxel, DRUG: Pertuzumab
| Inclusion Criteria:
* female patients, >=18 years of age;
* locally advanced, inflammatory or early stage invasive breast cancer;
* HER2 positive (HER2+++ by IHC or FISH/CISH+).
Exclusion Criteria:
* metastatic disease (Stage IV) or bilateral breast cancer;
* previous anticancer therapy or radiotherapy for any malignancy;
* other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
* insulin-dependent diabetes;
* clinically relevant cardiovascular disease. | 29,264 |
Study Objectives
The purpose of this study is to determine whether or not CTCs can be detected in blood samples taken from patients diagnosed with small cell lung cancer. The purpose is to compare CTC analysis to tumor samples to look for differences.
Conditions: Small Cell Lung Cancer
Intervention / Treatment:
| Inclusion Criteria:
* Histological proof of small cell lung cancer with extensive stage disease and have been untreated.
* Must be willing to give and sign informed consent.
* Must be 18 years of age
Exclusion Criteria:
* Less than 18 years of age. | 27,451 |
Study Objectives
This is a prospective randomised controlled trial to assess an intervention of inspection during both phases of colonoscopic examination ( insertion and withdrawal) improve adenoma detection rate when compared to inspection only during withdrawal.
Conditions: Adenoma Colon, Serrated Adenoma
Intervention / Treatment:
OTHER: Colonic inspection
| Inclusion Criteria:
* Participants who are referred for a bowel scope screening procedure
Exclusion Criteria:
* Patients lacking capacity to give informed consent
* Pregnant women
* Age less than 55 years
* Uncorrectable coagulopathy
* Patients who are not fit for flexible sigmoidoscopy
* Incomplete procedure | 25,511 |
Study Objectives
This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.
Conditions: Prostate Cancer, Castration Resistant Prostate Cancer, Pain, Prostatic Neoplasms
Intervention / Treatment:
DRUG: cabozantinib, DRUG: prednisone
| Inclusion Criteria:
* Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone less than 50 ng/dL).
* Evidence of bone metastasis related to prostate cancer on bone scans.
* Received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either abiraterone or MDV3100 treatment and has evidence of prostate cancer progression on each agent independently.
* Maintenance of LHRH agonist or antagonist unless treated with orchiectomy.
* Recovered from toxicities related to any prior treatments, unless the toxicities are clinically non significant or easily manageable.
* Adequate organ and marrow function.
* Capable of understanding and complying with the protocol requirements and signed the informed consent form.
* Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment.
Exclusion Criteria:
* Prior treatment with cabozantinib.
* Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks.
* Radiation within 4 weeks (excluded if to mediastinum) or radionuclide treatment within 6 weeks of randomization.
* Known brain metastases or cranial epidural disease.
* Requires concomitant treatment, in therapeutic doses, with anticoagulants.
* Requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort).
* Uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery.
* Clinically significant hematemesis or hemoptysis, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other significant bleeding in the past 6 months.
* Cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel.
* QTcF > 500 ms within 7 days of randomization.
* Unable to swallow capsules or tablets.
* Previously-identified allergy or hypersensitivity to components of the study treatment formulations.
* Another diagnosis of malignancy requiring systemic treatment within 2 years of randomization. | 16,487 |
Study Objectives
This is an observational retrospective cohort study to determine metachronous peritoneal carcinomatosis in a specific subgroup of colon cancer patients, those with a final pathologic exam corresponding to pT4 tumors.
Based on a sample size calculation of 1152 patients, a retrospective review of a three year period of every participant hospitals, 50 in total, of different characteristics, was stablished.
Demographic, clinical, operative, histologic and oncologic follow-up variables were recorded.
Conditions: Peritoneal Carcinomatosis, Colon Cancer
Intervention / Treatment:
OTHER: Follow-up
| Inclusion Criteria:
* Colon cancer above 15 cm from anal verge
* Curative intent surgery
* Pathologic confirmation of pT4 adenocarcinoma
Exclusion Criteria:
* R2 cancer resection
* Inclusion in other randomized clinical trials
* Pathologic diagnosis of colon cancer other than adenocarcinoma, such as GIST, leiomyosarcomas, neuroendocrine tumors, or other types even more unusual. | 1,937 |
Study Objectives
The goal of this psychosocial research study is to learn whether a website program called "Tendrils: Sexual Renewal for Women after Cancer " may help female cancer survivors improve their sex lives when used either as a self-help tool or in combination with brief sexual counseling by a health care professional.
Objectives:
Sexual dysfunction is the most common long-term consequence of cancer treatment, affecting half of survivors of breast and gynecological cancer and many women treated for other cancers. Yet, few women get the help they need for sexual problems. Our primary objective is to develop and evaluate a multimedia intervention program for women with cancer-related sexual dysfunction. Tendrils: A Sexual Renewal Program for Women Surviving Cancer will: 1) explain the causes of cancer-related sexual dysfunction; 2) offer self-help strategies to prevent or overcome problems; 3) advise women on seeking appropriate medical help; and 4) possibly serve as the core of a counseling program, along with a therapist manual. Tendrils is aimed at a wide audience, from newly diagnosed to long-term survivors, across cancer sites. Material will be presented with sensitivity to religious and cultural attitudes about sexuality. Animations will illustrate anatomy and physiology. The software will let women use Tendrils in a variety of formats: over the internet, on a CD-Rom, printed out, or as downloaded digital video or audio on a handheld computer or media player. Video vignettes will illustrate problems and strategies. Five female cancer survivors will host the program, sharing their experiences.
Conditions: Sexual Dysfunction
Intervention / Treatment:
BEHAVIORAL: Focus Group, BEHAVIORAL: TENDRILS, BEHAVIORAL: Questionnaires, BEHAVIORAL: Sexual Counseling Sessions
| Inclusion Criteria:
* Phase I: Woman cancer survivor* Phase I: Speaks and reads English well enough to evaluate the website and participate in a focus group* Phase II: Had breast cancer or a gynecological cancer diagnosed 1 to 5 years previously* Phase II: Has a sexual partner in relationship of at least 6 months' duration.* Phase II: Has a score on the Female Sexual Function Inventory below the cut-off criterion indicating sexual dysfunction (i.e. less than 26.55 total score).* Phase II: Lives in commuting distance of MDACC so that can attend 3 counseling sessions if randomized to professional treatment group.* Phase II: Currently no evidence of active cancer.* Phase II: Not receiving any cancer treatment other than hormonal therapy.
Exclusion Criteria:
* Phase I: Under age 18* Phase II: Under age 18* Phase II: Currently in mental health care for a sexual problem.* Phase II: BSI-18 at study entry indicates high distress and a visit with project staff confirms that the participant is too distressed to benefit safely from the intervention.* Phase II: Cannot arrange for participant to have privacy when accessing internet at home, even if we offer loaner laptop and subsidized internet service. | 18,078 |
Study Objectives
The aim of the project is to clarify whether DLBCL exhibits mutational diversity among different lymph node tumors in one and the same patient. It is desired to find out whether a possible difference between lymph node tumors / tumors can explain why patients who initially (at diagnosis) have the same prognosis, sometimes have a completely different course, eg with rapid recurrence of the disease after treatment.
A possible difference could also perhaps shed light on why disease in specific places spreads more frequently to the brain - and therefore have an impact on when one chooses to give preventive treatment against spread to the brain.
Monitoring of circulating cell-free DNA (ctDNA) is a new, potential, non-invasive tool for measuring the full spectrum of genetic variations / mutations and is to be investigated in our study as a possible non-invasive assessment of diversity / heterogeneity.
Conditions: Lymphoma, Large B-Cell, Diffuse
Intervention / Treatment:
| Inclusion Criteria:
* Diagnosed with DLBCL* Immunochemotherapy (rituximab and CHOP-like chemotherapy) planned and not yet initiated (pretreatment with prednisolone is allowed)* Age ≥ 18 years* More than 1 lymphoma site accessible for biopsy* Patient must consent to permit genetic analysis of their tumor biopsies* Patient must consent to additional biopsies and blood samples* Tumor biopsy and/or bone-marrow biopsy used for diagnosis available* Patient must consent to access of their medical records to monitor the clinical process* Written informed consent* Baseline 18FDG-PET/CT available
Exclusion Criteria:
* History of previous or current malignancies* Other previous/current hematological malignancies or inflammatory disease* HIV* Concurrent diagnosis of follicular lymphoma or other indolent lymphomas (composite histology)* If the patient is deemed to have an acute treatment need, the patient cannot be included in the project.* Patients on blood thinners, which must be paused before an additional biopsy, causing too much delay in initiating treatment will be excluded
- | 19,031 |
Study Objectives
This is a post-authorization, retrospective multicentre observational nationwide study (PAS-OD). It will be conducted by reviewing medical records and database of patients who participated in the validation of the psychometric properties of the GAH study (CEL-GAH-2011-01). In all cases, only data prior to the start date of the study will be collected to ensure its retrospective nature, thereby reflecting routine clinical practice and non-interference in the physician's clinical practice
Conditions: Myelodysplastic Syndromes, Leukemia Myeloid Acute, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell
Intervention / Treatment:
| Inclusion Criteria:
* Patients who were participating in the GAH study (CEL-GAH-2011-01).
* Patients who have been scheduled to start treatment at a date less than three months after completion of the GAH (CEL-GAH-2011-01) scale in one of these visits: baseline, test-retest or sensitivity to change.
* Patients who give informed consent to participate in the study as long as such consent is possible.
Exclusion Criteria:
* Not applicable | 549 |
Study Objectives
This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification. It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: nab-paclitaxel, DRUG: Bevacizumab, DRUG: Trastuzumab
| Inclusion Criteria:
* Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer
* Clinical stage T 1-4, N 0-3, M0
* FISH+ HER2 gene amplified breast cancer
* 18 years or older
* Normal cardiac function
* Performance status 0-2
* Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.
* Previous diagnosis of noninvasive breast cancer is OK.
* Must have adequate bone marrow, renal and liver function.
* Pregnant or lactating females not allowed.
* Preexisting peripheral neuropathy must be equal to or less than grade 1
* Must have archived tumor tissue for tissue testing.
Exclusion Criteria:
You cannot be in this study if you any of the following:
* History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure
* Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.
* No prior investigational drug within the last 30 days
* No prior trastuzumab or bevacizumab therapy
There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. | 1,974 |
Study Objectives
Radiotherapy is the primary treatment modality or an important adjunct treatment for many patients with H\&N carcinoma. Local control is directly related to dose and to the technical accuracy with which the dose is delivered to the target volume. Traditional radiotherapy techniques result in significant doses being delivered to normal tissues adjacent to the target, including the spinal cord and salivary glands. This leaves the patient with significant acute and late normal tissue toxicity that impacts on both the ability to tolerate the actual treatment and on the patient's long-term quality of life. Recently, the investigators have used static conformal multisegmental intensity modulated radiotherapy (IMRT) for a comprehensive irradiation of head and neck cancer with dose sparing of uninvolved tissues. This has resulted in substantial preservation of major salivary gland function in many patients with primary sites in the oral pharynx, oral cavity, nasopharynx, and pyriform sinus. While the investigators' results to date have shown promising preservation of salivary flow, they do not know whether patients treated with IMRT have similar local control rates as those treated with standard radiotherapy. Some investigators have raised the concern that by giving a low radiation dose to areas adjacent to the target volume there is a risk of undertreating the disease. On the other hand, the IMRT delivered with this protocol (called "simultaneous integrated boost", or SIB) may improve local control rates by delivering the same biologically effective dose in a shorter overall time period. This is a phase I/II trial which seeks to establish the efficacy of IMRT for H\&N cancer treatment, and to further investigate the relationship between radiation dose to the parotid glands, salivary flow, and quality of life.
Conditions: Head and Neck Cancer
Intervention / Treatment:
PROCEDURE: Intensity-Modulated Radiation Therapy
| Inclusion Criteria:
* Squamous cell cancer of head and neck for radical/postoperative radiation therapy
* American Joint Committee on Cancer (AJCC) stage I-IV with M0 and N0-2 disease
* Karnofsky performance status (KPS) >= 70%
Exclusion Criteria:
* M1 or N3 disease
* Ineligibility for radiotherapy
* Recent malignancy
* Previous cancer or head and neck radiotherapy
* Salivary gland dysfunction
* Unwilling to provide informed consent | 22,780 |
Study Objectives
This is a prospective observational study aiming: 1) To quantify lung function using perfusion dual energy computed tomography (DECT) and use this information at the time of treatment planning with preferential sparing of functional lung parenchymal 2) to validate results of lung function obtained using DECT with lung perfusion scintigraphy results, the current standard method; 4) to compare dosimetry of whole lungs vs. functional lungs in patients treated with either stereotactic body radiotherapy (SBRT) for early stage lung cancer or conventional radiotherapy for locally advanced lung cancer and 5) to evaluate lung function 6, 12 and 24 months post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.
Conditions: Lung Cancer, Lung Function Decreased, Radiation Pneumonitis
Intervention / Treatment:
RADIATION: Thoracic radiotherapy
| Inclusion Criteria:
* ≥ 18 years
* ECOG 0-2
* Pulmonary neoplasia, confirmed histopathologically or by imaging
* Prognosis evaluated ≥ 1 year by attending MD
* Clinically acceptable lung capacity to undergo radiotherapy
* Initial assessment including history, physical examination, biochemistry, PFT, chest radiograph, chest and abdominal-pelvic scan, PET
* Written consent
* The patient must be available for treatment and monitoring. Patients registered in the study should be treated in our center.
Exclusion criteria
* Previous radiotherapy in the radiation field
* Presence of any major medical condition that, in the opinion of the investigator, would prevent follow-up at 6, 12 and 24 months post-radiotherapy.
* Iodine allergy
* Pregnancy and lactation | 18,416 |
Study Objectives
This community-based randomized trial tested the effects of a social support intervention to increase Chamorro, Samoan, and Tongan women's Pap test behavior and social support among their male spouses or significant others in Southern California.
Conditions: Cervical Cancer
Intervention / Treatment:
BEHAVIORAL: Intervention
| Inclusion Criteria:
* Women ages 21 to 65
* Of Chamorro, Samoan, and/or Tongan ethnicity
* Has a significant other (married or in a long-term relationship for more than 5 years).
Exclusion Criteria:
* Not a member of one of the churches or clans visited for recruitment | 12,680 |
Study Objectives
The association between radiation exposure and cardiac disease is well recognized, it is not fully understood if there exists an optimal or "safe" radiation dose-volume relationship.
Conditions: Node Positive Breast Cancer
Intervention / Treatment:
RADIATION: Radiation therapy groups
| Inclusion Criteria:
* Women with node positive breast cancer treated with surgery, anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.
Exclusion Criteria:
* Women who have not received anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007. | 7,762 |
Study Objectives
The purpose of the study is to understand the effect of Metformin on patients with PCOS.
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Intervention / Treatment:
DRUG: Metformin intervention for 12 weeks
| Inclusion Criteria:
* Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.* Individuals who are diagnosed as PCOS according to the revised 2003 Rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).* Individuals who can insist on continuous monitoring in the outpatient clinic. Individuals who are not participating in other research projects currently or 3 months before the intervention.
Exclusion Criteria:
* Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.* Individuals who are during pregnant, lactation or menopause.* Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.* Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months.* Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.* Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.* Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.* A medical history of severe cardiovascular and cerebrovascular diseases.* Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.* Individuals who drink more than 15g of alcohol per day or have a smoking habit.* Individuals who need drug treatment for any mental illness such as epilepsy and depression.* Cancer patients.* Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc. | 4,341 |
Study Objectives
The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer is estimated to be high, \> 90%. The standard treatment for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is performed afterwards. This standard regimen causes a lot of side effects and long term complications. This study is evaluating whether a lower dose of radiation and chemotherapy may provide a similar cure rate as the longer, more intensive standard regimen. Patients in this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy followed by a limited surgical evaluation.
Conditions: Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms
Intervention / Treatment:
RADIATION: Intensity Modulated Radiotherapy (IMRT), DRUG: Cisplatin, PROCEDURE: Limited surgical evaluation
| Inclusion Criteria:
* ≥ 18 years of age* T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx* Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive* ≤ 10 pack-years smoking history or > 5 years of abstinence from smoking* History/physical examination within 8 weeks prior to registration* Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration.* The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1* Complete Blood Count (CBC)/differential obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl.* Adequate renal and hepatic function within 4 weeks prior to registration, defined as follows: Serum creatinine < 2.0 mg/dl; Total bilirubin < 2 x the institutional upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN.* Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.* Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.* Patients must be deemed able to comply with the treatment plan and follow-up schedule.* Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria:
* Prior history of radiation therapy to the head and neck* Prior history of head and neck cancer.* Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol; Pre-existing ≥ grade 2 neuropathy; Prior organ transplant.* Known HIV positive* Significant pre-existing hearing loss, as defined by the patient or treating physician. | 32,583 |
Study Objectives
The purpose of this study is to evaluate the efficacy and safety of amolimogene, in the treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix.
Conditions: Uterine Cervical Dysplasia
Intervention / Treatment:
DRUG: Amolimogene, DRUG: Amolimogene, OTHER: Placebo
| Inclusion Criteria:
To be considered for enrollment, patients must:
* Have an abnormal Pap smear (atypical squamous cells of undetermined significance \[ASCUS\], atypical squamous cells, cannot exclude high grade \[ASC-H\], low grade squamous intraepithelial lesion \[LSIL\], high grade squamous intraepithelial lesion \[HSIL\]) result within 6 months of screening visit.* Have a colposcopically visible lesion suspected to be high-grade that does not involve more than 75% of the cervix.* Have a CIN 2/3 consensus pathology diagnosis on tissue taken from a colposcopically-directed punch biopsy.* Not have evidence of cervical carcinoma on Pap smear or biopsy and not have a positive endocervical curettage.* Not have atypical endometrial cells or glandular-cell atypia on Pap smear or biopsy.* Have colposcopic visualization of entire squamocolumnar junction and of the entire lesion (i.e. cannot extend into canal).* Not have concomitant cancer, history of malignancies, including carcinoma of the cervix, except for non-melanoma skin cancer.* Be willing to sign an Institutional Review Board (IRB) approved informed consent. Minors must have the consent of a parent or legal guardian as required by local laws and regulations.* Agree to use 2 acceptable forms of contraception (e.g., double-method including at least one barrier and one hormonal method).* Be capable of complying with the protocol.* Not have other illnesses that would put the patient at undue risk for participation in the trial or would interfere with the required clinical observations.* Not have abnormalities of hematological, renal, or hepatic function as determined by clinical laboratory testing.* Not have immunologic disorder such as immunodeficiency, lupus, or other chronic auto-immune disease.* Not have an active systemic infection requiring treatment.* Not have ongoing systemic chronic steroid therapy or immunosuppressive medication (inhalers used for treating asthma and topical steroids are permitted).* Not be positive for HIV antibody.* Not be pregnant or lactating.* Not plan to use a cervical cap or diaphragm during the study.* Not have been treated with any investigational agent within 30 days prior to randomization in this trial.* Not have had prior gene therapy.* Not have had an excisional or ablative procedure performed on the cervix within one year of enrollment.* Be willing to consent to an excisional procedure, such as LEEP or cold-knife cone procedure, if indicated.
Please note: There may be additional inclusion/exclusion criteria. The study center will determine if patients meet all of the criteria. If patients do not qualify for the trial, study personnel will explain the reasons. If patients do qualify, study personnel will explain the trial in detail using an IRB-approved informed consent, and answer any questions. Patients can then decide if they wish to participate. | 23,428 |
Study Objectives
Currently, there is a lack of patient education materials regarding cytotoxic chemotherapy side effects, research supported treatments, and the utilization of CAM by cancer patients at Penn State Cancer Institute. The investigators aim to develop an educational brochure, which educates patients about the chemotherapy side effects they may experience, and provide them with the tools to address the problem themselves, know when to contact their medical oncologist, and understand when it is appropriate to go to the Emergency Department. By educating patients regarding these problems, patient anxiety may decrease, the number of calls into the oncologist office may decrease, and Emergency Department visits may decrease, which would decrease costs for the patient, the hospital, and the health system. If this intervention is found to be useful and impactful, it can be further utilized within the Cancer Institute by other disease teams, by other Penn State institutions, or by other institutions across the country.
Conditions: Chemotherapeutic Toxicity, Chemotherapeutic Agent Toxicity, Chemotherapy Effect
Intervention / Treatment:
OTHER: Educational Brochure
| Inclusion Criteria:
* Adults with a diagnosis of breast or gastrointestinal cancer, at any stage or progression, who are cytotoxic chemotherapy treatment naïve and initiating treatment or have newly begun cytotoxic chemotherapy within the last 6 weeks. Patients receiving multiple therapy forms, such as immune or humoral, can be included if they are also receiving cytotoxic chemotherapy as a part of their regimen. All patients will receive the brochure, therefore, there will not be a control arm in this study.
1. Adult >20 year of age
2. Ability to understand and read written English without any functional difficulty
3. ECOG performance status 0-3
4. May be involved with other cancer trials being offered at the Penn State Cancer Institute
Exclusion Criteria
* Inability to give informed consent* Pregnant females* Inability to understand or read written English* Patients who have previously undergone cytotoxic chemotherapy at any point in their lifetime or began chemotherapy for their breast or gastrointestinal cancer greater than 6 weeks from the initiation of the study | 5,915 |
Study Objectives
Soft tissue sarcoma STS is a group of malignant tumors derived from connective tissue other than bone and cartilage. It can occur in any part of the body at any age, and there is no significant gender difference.According to pathological classification, STS has 19 tissue types and more than 50 disease subtypes.Currently, surgical resection, radiotherapy and drug therapy are the main treatment methods.But about 50% of the patients with distant metastasis happened not the surgical removal of, quite a number of in patients with distant metastasis after died of disease progression 8-12 months in drug treatment of soft tissue sarcoma, the current widely used chemotherapy regimens for ADM/IFO single-agent or joint IFO ADM is a line of chemotherapy, in addition, paclitaxel, gemcitabine, dorsey race, it was also used for soft tissue sarcomas of second-line chemotherapy scheme, however, for some special subtypes of sarcoma,Such as myxoid liposarcoma, pleomorphic rhabdomyosarcoma, leiomyosarcoma, glandular soft tissue sarcoma and superficial malignant fibrous histiocytoma, are not sensitive to chemotherapy or low sensitivity.Therefore, how to improve the survival rate of these patients is an urgent problem to be solved.
Anlootinib hydrochloride is a multi-target tyrosine kinase inhibitor that has shown good efficacy in solid tumors such as NSCLC, ovarian cancer, soft tissue tumors, and medullary thyroid cancer.Especially in the field of soft tissue sarcomas, the results of phase IIb clinical data were satisfactory.Therefore, Investigator plan to conduct the study of anrotenil hydrochloride capsule for the treatment of soft tissue sarcomas with first-line chemotherapy failure (anthracycline)
Conditions: Soft Tissue Sarcomas
Intervention / Treatment:
DRUG: Anlotinib Hydrochloride
| Inclusion Criteria:
* The patients volunteered to participate in this study and signed the informed consent;* Pathologically confirmed advanced soft tissue sarcomas with at least one measurable lesionMainly including Synovial sarcoma (Synovial sarcoma), Leiomyosarcoma (Leiomyosarcoma), gland Alveolar soft tissue sarcoma (Alveolar soft part sarcoma), Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma), liposarcoma (AdipocyticEpithelial sarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, and other Tumors.Except for:Malignant peripheral nerve sheath tumor, Undifferentiated sarcoma, Rhabdomyosarcoma, chondrosarcoma, Osteosarcoma, dermato-fibrosarcomaProtuberans, gastrointestinal stromal tumor, Primitive neuroectodermal tumor, Inflammatory myofibroblastic tumor, Malignant mesothelioma.* Patients who have failed treatment with at least one or two line chemotherapy regimen (doxorubicin + ifosfamide, gemcitabine + docetaxel) within the last 6 months (except for acinar soft tissue sarcoma);\[note: treatment failure refers to the occurrence of disease progression or intolerance during treatment or within 3 months of the last treatment\]* 18 \~ 70 years old;ECOG PS score is 0\~1;Expected survival beyond 3 months;* Patients who are effective with other targeted drugs, but have drug resistance and disease progression, and stop taking drugs for more than 4 weeks;* Major organ functions meet the following criteria within 7 days before treatment:
1. blood routine examination standard (in the condition of no blood transfusion within 14 days) :
* hemoglobin (HB) ≥90g/L;
* absolute value of neutrophils (ANC)≥1.5×109/L;
* platelet (PLT) ≥80×109/L
2. biochemical examination shall meet the following standards:
* total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN);
* alanine aminotransferase (ALT) and aspartate aminotransferase AST≤ 2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN;
* serum creatinine (Cr)≤1.5×ULN or creatinine clearance rate CCr≥60ml/min;
3. doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).* Women of childbearing age should agree that they must obtain a certain amount during the study period and within 6 months after the study Use contraceptives (such as intrauterine devices, birth control pills or condoms);Negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating;Men should agree to patients who must use contraception during the study period and within 6 months of the end of the study period.
Exclusion Criteria:
* Patients who have previously used anlotinib hydrochloride capsules;* With pleural effusion or ascites, cause respiratory syndrome (≥CTC AE grade 2 dyspnea);* Patients who have received targeted therapy of vascular endothelial growth inhibitors, such as sunitinib, sorafenib, imatinib, bevacizumab, famitinib, apatinib, reagfenib and other drugs, have failed to respond to treatment.Other malignancies were present or present at the same time within 4.5 years, except cured carcinoma in situ of the cervix, non-melanoma skin cancer and superficial bladder tumor \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];* Systemic antitumor therapy, including cytotoxic therapy, immunotherapy, or mitomycin C, was planned for the first 4 weeks of the group or in this study.Radiotherapy was performed in the first 4 weeks or in the second 2 weeks before the grouping.* Unrelieved toxic reactions above CTC AE(4.0) level 1 due to any previous treatment, excluding hair loss;* Having multiple factors affecting oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction);* Patients with brain metastasis with symptoms or symptom control time less than 2 months;* Patients with any serious and/or uncontrolled illness, including:
1. Patients with unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);
2. Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc≥480ms) and grade ii or above congestive heart failure (New York heart association grade (NYHA));
3. Active or uncontrolled severe infection (≥ grade CTC AE 2 infection);
* Patients with cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis should receive antiviral treatment;
* Renal failure requires hemodialysis or peritoneal dialysis;* Patients with any serious and/or uncontrolled illness, including:
1. a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
2. poor diabetes control (FBG > 10mmol/L);
3. the urine routine indicated that urine protein ≥++, and confirmed the 24-hour urine protein quantitative > 1.0g.
4. patients with seizures requiring treatment;* Significant surgical treatment, open biopsy or significant traumatic injury received within 28 days prior to grouping;* Any physical signs or history of bleeding, regardless of severity;Unhealed wounds, ulcers or fractures were found in patients with any bleeding or bleeding event ≥CTCAE level 3 within 4 weeks before grouping;* 6 months in the event of overactive/venous thrombosis, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism;* Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;* Participated in clinical trials of other anti-tumor drugs within four weeks; According to the researchers' judgment, there are concomitant diseases that seriously endanger patients' safety or prevent patients from completing the study. | 32,561 |
Study Objectives
The purpose of this study is to determine the safety and effectiveness of a multi-drug regimen (which includes prednisone, vincristine, cytarabine, doxorubicin, 6 mercaptopurine, and methotrexate) which is considered standard treatment for children and young adults with acute lymphoblastic leukemia (ALL), in combination with PEG-asparaginase and clofarabine to treat older adults with ALL. PEG-asparaginase has been used in chemotherapy treatment regimens for both children and adults with ALL. Clofarabine has been used in chemotherapy treatment regimens for children with ALL and has been shown to decrease the number of leukemia cells. Participants with leukemia that has an abnormal chromosome, called the Philadelphia chromosome, will also be given imatinib.
Conditions: Acute Lymphoblastic Leukemia
Intervention / Treatment:
DRUG: Prednisone, DRUG: Vincristine, DRUG: Doxorubicin, DRUG: PEG-asparaginase, DRUG: Cytarabine, DRUG: Methotrexate, DRUG: Imatinib, DRUG: Clofarabine, DRUG: 6 Mercaptopurine
| Inclusion Criteria:
* Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8).
* Patients with mature B-cell ALL will be removed from the protocol as soon as the diagnosis is made and should be treated on a B-cell leukemia protocol.
* Patients with lymphoblastic lymphoma are also eligible
* No prior anti-leukemic therapy except <1 week of steroids, and/or emergent radiation therapy to the mediastinum, or hydroxyurea or emergent leukopheresis. Longer steroid use for diseases other than leukemia is permitted.
* Age 51-75 years
* Ejection fraction > 45%
* Creatinine < 2.0 mg/dl
* Total bilirubin < 3.0 mg/dl
* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, 2
* Non-pregnant and non lactating
Exclusion Criteria:
* Known HIV positive
* Comorbid medical condition, in the investigator's opinion, would make participation in this trial and adherence to the protocol guidelines difficult
* Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely | 21,496 |
Study Objectives
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable lung cancer.
Conditions: Small-cell Lung Cancer
Intervention / Treatment:
DEVICE: Cancer ablation, DRUG: Life information rehabilitation therapy
| Inclusion Criteria:
* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, with at least one tumor length > 2 cm
* KPS ≥ 70, lifespan > 6 months
* Platelet count ≥ 80×109/L,white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Exclusion Criteria:
* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction | 29,743 |
Study Objectives
Fruquintinib with PD-1 inhibitors (FP) and TAS-102 with bevacizumab (TB) are two common therapies for patients with previous-treated metastatic colorectal cancer (mCRC). However, it's still not clear that which therapy can bring better prognosis. Our study sought to investigate the efficacy and safety of fruquintinib with PD-1 Inhibitors versus TAS-102 with bevacizumab in Late-Line mCRC between July 2019 to October 2022July 2019 and June 2021 at the Hunan Cancer Hospital.
Conditions: Metastatic Colorectal Adenocarcinoma
Intervention / Treatment:
DRUG: Fruquintinib, DRUG: PD-1 inhibitors, DRUG: Trifluridine/Tipiracil, DRUG: Bevacizumab
| Inclusion Criteria:
* Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).* Have progressed from at least 2 lines of standard treatment,including fluoropyrimidines, irinotecan, oxaliplatin, with or without targeted drugs, like bevacizumab and cetuximab (only for RAS wild-type). Regorafenib was permitted but not required for inclusion.* Has measurable or non-measurable disease as defined by RECIST version 1.1* Is able to swallow oral tablets.* Estimated life expectancy ≥12 weeks.* Eastern Cooperative Oncology Group performance status (ECOG PS) less than 2* Has adequate organ function.
Exclusion Criteria:
* Pregnancy, lactating female or possibility of becoming pregnant during the study.* Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).* Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.* Has severe or uncontrolled active acute or chronic infection.* Known carriers of HIV antibodies.* Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia. | 18,112 |
Study Objectives
The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.
Conditions: Chronic Pain, Cancer Pain, Intractable Pain, Back Pain
Intervention / Treatment:
DEVICE: Prometra Programmable Intrathecal Infusion Pump
| Inclusion Criteria:
* Patient meets at least one of the following:
* is suffering from malignant pain (i.e., cancer pain)
* has chronic, non-malignant pain
* subject was enrolled in PUMP I or PUMP II study and chooses to participate in this Post-Approval study
* Patient with an existing implantable pump for pain therapy that requires replacement* Patient is at least 22 years of age.* Investigator considers the patient to be able and willing to fulfill all study requirements.* Patient has provided written informed consent to participate in the study.
Exclusion Criteria:
* Patient meets any of the contraindications for use of the Prometra System* Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma.* Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control. | 2,273 |
Study Objectives
The purpose of this study is to obtain an estimate of the objective response rate (ORR) of AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma failing frontline chemotherapy.
Conditions: Ovarian Neoplasms
Intervention / Treatment:
BIOLOGICAL: AMG 479
| Inclusion Criteria:
* Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma. Baseline paraffin embedded tissue from the patient's primary diagnosis is requested before study enrollment and should be forwarded to the designated central laboratory. In patients with measurable disease or sufficient ascites, fresh frozen tissue or ascites fluid should be obtained by needle biopsy and submitted to the designated central laboratory.
* Prior treatment with at most 1 treatment regimen in the primary treatment setting.
* Platinum-sensitive disease defined by recurrence or progression of disease > 6 months AND < 24 months after completion of prior platinum based chemotherapy.
* Female > 18 years of age or legal age.
* ECOG performance status ≤ 1.
* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Subjects with non-measurable disease with a biochemical recurrence are eligible provided the CA 125 is elevated by more than 2 times the upper limits of normal, confirmed in two successive samples, drawn at least one week apart.
* Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE v.3.0 Grade ≤ 1 and to baseline laboratory values as defined in the inclusion criterion immediately below.
* Adequate organ and bone marrow function
* Nondiabetic patients or Type 1 or 2 Diabetic Patients controlled with HgbA1c < 8% and fasting blood glucose level <160 mg/dL
* Adequate coagulation parameters (within 21 days prior to registration), International Normalized Ratio (INR) ≤1.5; Activated ProThrombin Time (APTT) ≤ 1.5 x ULN.
Exclusion Criteria:
* More than 1 prior chemotherapy regimen in the treatment of ovarian cancer.
* Platinum-resistant disease as defined by a recurrence or progression less or equal to six months after completion of the frontline platinum based chemotherapy.
* Anticipation of a need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial.
* Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
* Prior treatment with investigational treatment targeted to IGF axis including, but not limited to, CP 751,871, IM-A12, RO4858696.
* Previous exposure to AMG 479.
* History of hypersensitivity to recombinant proteins.
* Prior treatment with a humanized monoclonal antibody.
* Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrolment.
* Any of the following within 6 months prior to trial registration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
* History of brain metastases, spinal cord compression, or carcinomatous meningitis.
* Patient of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding.
* Patient of child-bearing potential is not willing to use adequate contraceptive precautions.
* Known active infection, or on antiretroviral therapy for HIV disease.
* Known positive test for chronic hepatitis B or C infection.
* Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the trial.
* Refusal or inability to give informed consent to participate in the trial.
* Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial. | 4,679 |
Study Objectives
This study is being done to compare standard radiation therapy with hypofractionated radiation therapy for patients with newly diagnosed glioblastoma
Conditions: Glioblastoma
Intervention / Treatment:
RADIATION: Hypofractionated radiation therapy, RADIATION: Standard radiation therapy
| Inclusion Criteria:
* Newly-diagnosed, histologically proven, intracranial glioblastoma or gliosarcoma treated with maximal safe resection, which may be biopsy alone if resection is not possible.* History and physical examination, including neurological examination, within 14 days prior to randomization.* Age between 18 and 70 years, inclusive.* ECOG performance score 0-2.* Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization (Stupp et al.).* Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below: (Stupp et al.)
1. ANC ≥ 1.5 x 10\^9/L
2. Platelets ≥ 100 x 10\^9/L
3. Serum creatinine ≤ 1.5 times ULN
4. Total serum bilirubin ≤ 1.5 times ULN
5. ALT < 3 times ULN
6. AST < 3 times ULN
7. Alkaline phosphatase < 3 times ULN* Patients must sign a study-specific informed consent prior to study registration and must be willing to comply with study treatment, questionnaire completion and follow-up.
Exclusion Criteria:
* Recurrent or multifocal malignant gliomas. Multicentric gliomas, defined as multiple, discrete areas of enhancement on T1 weighted MRI sequences with contrast all contained within one connected region of abnormality on T2 weighted/FLAIR MRI sequences, are allowed to enroll on this study.* Prior invasive malignancy (except for non-melanomatous skin cancer) unless expected survival from prior malignancy is ≥ 5 years.* Prior head or neck RT (except for T1 glottic cancer), or systemic therapy precluding delivery of concurrent and adjuvant temozolomide* Treatment with any other therapeutic clinical protocol within 30 days prior to study registration or during participation in the study.* Severe, active co-morbidity, defined as follows:
1. Unstable angina and/or congestive heart failure requiring hospitalization
2. Transmural myocardial infarction within the last 6 months
3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study registration
4. Any severe, active co-morbidity precluding delivery of temozolomide.* Women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.* Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to temozolomide. | 14,360 |
Study Objectives
The purpose of this study is to evaluate the safety and pharmacokinetics and assess the immunogenicity and effectiveness of AGS-16C3F in subjects with renal cell cancer (RCC).
Conditions: Carcinoma, Renal Cell, Renal Cell Carcinoma of Papillary Histology, Renal Cell Carcinoma With Clear Cell Histology, Renal Cell Carcinoma With Non-Clear Cell Histology
Intervention / Treatment:
DRUG: AGS-16C3F
| Inclusion Criteria:
* Dose determination cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or non-clear histology.
* Tumors with clear cell histology: subject must have progressed after at least one anti-vascular endothelial growth factor receptor (anti-VEGFR) therapy
* Tumors with non-clear cell histology must be ectonucleotide pyrophosphatase/phosphodiesterase family member 3 (ENPP3) positive at pre-screening. This sub-group does not have any prior therapy requirement.
* Dose expansion cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or papillary histology
* Tumors with clear cell histology: subject must have progressed after at least one anti-VEGFR therapy
* Tumors with papillary histology: includes unclassified histology with papillary features and must be ENPP3 positive at pre-screening. This sub-group does not have any prior therapy requirement.
* Measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)
* Eastern Cooperative Group (ECOG) performance status of 0-1
* Hematologic function, as follows:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Hemoglobin ≥ 9 g/dL (transfusions are allowed)
* Renal function, as follows:
* creatinine ≤ 1.5 x upper limit of normal (ULN), or calculated glomerular filtration rate (GFR) > 50 mL/min if creatinine > 1.5x ULN
* Hepatic function, as follows:
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5x ULN if known liver metastases
* Total bilirubin ≤1.5 x ULN
* International normalized ratio (INR) < 1.3 (or ≤ 3.0 if on therapeutic anticoagulation)
* Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for 4 weeks after the last AGS-16C3F infusion administration
Exclusion Criteria:
* Current uncontrolled central nervous system (CNS) metastasis or malignant brain tumors
* Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening. No time limit applies to the use of marketed drugs approved for this indication provided that the subject has progressed on the treatment and all toxicities attributable to the drug have resolved or returned to baseline
* Known sensitivity to any of the ingredients of the investigational product AGS-16C3F
* History of thromboembolic events and bleeding disorders ≤3 months (e.g., (deep vein thrombosis) DVT or pulmonary embolism (PE))
* Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by outpatient medication.
* Major surgery within 4 weeks of study enrollment
* Women who are pregnant (confirmed by positive pregnancy test) or lactating
* Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen.
* Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening.
* History of eye surgery within 6 months, presence of cataracts or other ocular disorders significantly affecting vision | 20,935 |
Study Objectives
Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification.
This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart.
Secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.
Conditions: Skin Neoplasms, Carcinoma, Basal Cell
Intervention / Treatment:
DRUG: MAL-PDT re-treatment, DRUG: usual MAL-PDT
| Inclusion Criteria:
* male/female above 18 years of age
* written informed consent
* 1 or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type
Exclusion Criteria:
* pregnancy
* breastfeeding
* Gorlin's syndrome
* porphyria
* xeroderma pigmentosum
* history of arsenic exposure
* known allergy to MAL
* concomitant treatment with immunosuppressive medication
* physical or mental conditions that most likely will prevent patients attending follow-up sessions | 4,645 |
Study Objectives
A prospective observational longitudinal study of 464 patients was performed between 2010 and 2015. Patients with invasive ductal carcinoma (IDC) and ductal carcinoma in situ associated to invasive ductal carcinoma (DCIS +IDC) were included and analyzed.
Conditions: Outcome of Breast Cancer
Intervention / Treatment:
OTHER: None intervention
| Inclusion Criteria:
* Patients with invasive ductal carcinoma of the breast
* Patients who received surgery for primary invasive breast cancer between 2010 and 2015
Exclusion Criteria:
* Patients with metastasis at the diagnostic | 23,410 |
Study Objectives
This is the first study in which TAK-441 is administered to humans. The patient population will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for whom standard treatment is no longer effective or does not offer curative or life-prolonging potential. Following completion of the dose escalation study, patients will be enrolled as part of 2 expansion cohorts.
Conditions: Advanced Nonhematologic Malignancies, Carcinoma, Basal Cell
Intervention / Treatment:
DRUG: TAK-441
| Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
* Male or female 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential
* Meet other clinical, radiographic or laboratory inclusion criteria as specified in the protocol
* Voluntary written consent
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
* Life-threatening illness unrelated to cancer
* Receiving other treatment (radiotherapy, antineoplastics or investigational agents) within protocol specified windows of first dose of TAK-441
* Patients with brain metastases who do not meet criteria specified in study protocol
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
* Major surgery within 14 days before the first dose of TAK-441
* Infection requiring systemic therapy, or other serious infection within 14 days of the first dose of TAK-441
* Do not meet other clinical, laboratory or radiographic criteria as specified in the protocol | 16,675 |
Study Objectives
The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo for a 3-6 week period to see if we can slow down the rate of prostate cancer growth. A placebo is a pill or something that looks like the medicine that is being studied but has no active medicine in it. We also want to see if taking purified isoflavones is safe and if it reduces lower urinary tract symptoms. In addition, we want to study if purified isoflavones are able to slow the progression of prostate cancer, and the mechanism of action of purified isoflavones. If the safety and the effects of purified isoflavones on slowing down the progression of prostate cancer is shown in our study, this will also be a safe way of treating men who are at high risk of prostate cancer, so that we can prevent prostate cancer in the future.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Purified isoflavones, DRUG: Methyl cellulose blend
| Inclusion Criteria:
* Diagnosis of localized prostate cancer (PCa), based on pathological assessment from biopsy specimens
* No prior or current therapy for PCa or history of cancer except non-melanoma skin cancer
* Scheduled for prostatectomy between 3- 6 weeks (+/-3 days) after start of study agent
* No known history of hepatic or renal disease (LFTs (SGOT/SGPT) > 5.0 x upper limit of normal as evidenced by impairment of baseline laboratory values, Actual creatinine clearance of >60 utilizing the Cockcroft-Gault formula (1976), which employs creatinine measurements and a patient's weight to predict the clearance. The constant is 1.23 for men.
* Omnivorous diet
* No evidence of prostatitis or urinary tract infection
* Able and willing to give written informed consent
* Currently not using or willing to discontinue any nutritional supplements that contain soy or soy isoflavones
* Not allergic to study supplements
* Not on antibiotics
* Men who do not consume more than 3 - 4 oz. of soy or soy products per week
* Not taking steroid hormones or medications which have known impact on prostatic specific antigen (PSA)
* Health status cleared by primary MD or urologist
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Exclusion Criteria:
* Prior history of prostate cancer; Current or prior history of other malignancies (exceptions include nonmelanoma skin cancer or other cancer with no evidence of tumor recurrence five years after definitive treatment)
* History of renal or hepatic disease, including history of hepatitis B, C or delta as evidenced by impairment of baseline laboratory values
* Participation in any other investigational study or use of any other investigational agents within 30 days of study entry
* History of allergic reactions attributed to soy isoflavones or other compounds of similar chemical or biologic composition to Novasoy 400® or the inactive components present in the purified isoflavone and placebo capsules
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any psychological, familial, sociological or other concomitant condition that would not allow adequate compliance with the study protocol
* Only African American (a person having origins in any of the black racial groups of Africa) and Caucasian (a person having origins in any of the original people of Europe, Middle East, or North Africa) men, as defined by the NIH, will be included in this study. Since this is an investigation targeting men with PCa, women are not eligible for the study. | 8,211 |
Study Objectives
This 2-phase study will determine the safety of treating patients with prostate cancer with the genetically engineered HyperAcute-Prostate cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed prostate cancer cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink.
Patients 19 years of age or older with hormone refractory prostate cancer that has recurred or no longer responds to standard treatment may be eligible for this study. Candidates will be screened with medical history and physical examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if needed.
Participants will receive twelve vaccinations two weeks apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 2 months for the remaining first year (6 months) after vaccination and then every 3 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects:
* Medical history and physical examination
* Blood tests
* X-rays and various scans (nuclear medicine/CT/MRI)
* FACT-P Assessment questionnaire to measure the impact of treatment on the patient's general well-being. The questionnaire is administered before beginning treatment, monthly during treatment, and during follow-up visits after completing the treatment. It includes questions on the severity of prostate cancer symptoms and the ability to perform normal activities of daily life.
Conditions: Prostate Cancer
Intervention / Treatment:
BIOLOGICAL: HyperAcute-Prostate Cancer Vaccine
| Inclusion Criteria:
* Phase I and Phase II Arm A: A histological diagnosis of prostate cancer with evidence of metastatic disease by CT scan or bone scan. Phase II, Arm B: Evidence of hormone refractive progressive disease by increasing PSA only.
* For patients enrolling in Phase II, Arm B: refractory to hormone therapy defined by: two consecutive increases in PSA documented over a previous reference value, the first occurring a minimum of 1 week from the reference value, with one value of at least 4 ng/mL and the increase(s) must be by at least 1.0 ng/mL.
* Castrate testosterone levels < 50 ng/dl (0.50 ng/mL)
* AJCC Stage IV (any T, any N, M1), hormone refractory metastatic, progressive or recurrent prostate carcinoma. Patients must have failed one attempt at hormonal therapy and may have received 2 prior chemotherapy regimens.
* ECOG performance status less than or equal to 2.
* Serum albumin greater than or equal to 3.0 gm/dL.
* Expected survival greater than or equal to 6 months.
* Subjects must have a negative serology for Hep B, C, and HIV prior to entering study.
* Adequate organ function including:
Marrow: \*Hemoglobin greater than or equal to 10.0 mg/dL, \*absolute granulocyte count (AGC) greater than or equal to 1,500/mm(3), \*platelets greater than or equal to 100,000/mm(3), \*absolute lymphocyte count greater than or equal to 475/mm(3).
Hepatic: \*serum total bilirubin less than or equal to 1.5 x upper limit of normal (ULN), \*ALT (SGPT) and AST (SGOT) less than or equal to 2.5 x ULN.
Renal: \*serum creatinine less than or equal to 2.0 x ULN or creatinine clearance greater than or equal to 30 mL/min.
* All on-study tests must be less than or equal to Grade I toxicity for patient to be eligible for study, excluding serum LDH levels. PT, PTT must be less than or equal to 1.5 x ULN except for patients who are on therapeutic anticoagulant therapy.
* Measurable or bone metastases (Phase I, Phase II-Arm A) or non-measurable disease (Phase II-Arm B).
* Patients must have been treated with hormonal therapy and may have been treated with surgery and/or radiation therapy and/or less than or equal to 2 different chemotherapy regimens (including neoadjuvant and adjuvant treatment).
* Patients must be greater than or equal to 4 weeks since major surgery, radiotherapy, chemotherapy (6-weeks if they were treated with a nitrosourea or mitomycin) and recovered from the toxicity of prior treatment to less than or equal to Grade 1, exclusive of alopecia or fatigue.
* Patients must have the ability to understand the study, its risks, side effects, potential benefits and is able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
* Male subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental drug, and for one month after the last immunization.
* Patients taking bisphosphonates at the time of registration into the trial are eligible, but bisphosphonates must be continued at a constant level throughout the trial period. Bisphosphonate use must be initiated at least 28 days prior to first treatment.
Exclusion Criteria:
* Age less than 19 years of age.
* Active CNS metastases or carcinomatous meningitis.
* Hypercalcemia greater than 2.9 mmol/L, unresponsive to standard therapy.
* Other malignancy within last 5 years, unless the probability of recurrence of the prior malignancy is less than 5%. Patients curatively treated for squamous and basal cell carcinoma of the skin or patients with a history of malignant tumor in the past that have been disease free for at least 5 years are also eligible for this study.
* History of organ transplant or active immunosuppressive therapy (such as cyclosporine, tacrolimus, etc.).
* Subjects taking systemic corticosteroid therapy for any reason are not eligible.
* Significant or uncontrolled congestive heart failure, myocardial infarction or significant ventricular arrhythmias within the last six months.
* Active infection or antibiotics within 1-week prior to study, including unexplained fever (temp. greater than 38.1 degrees Celsius).
* Autoimmune disease (e.g., systemic lupus erythematosis, active rheumatoid arthritis, etc). Patients with a remote history of asthma or mild active asthma are eligible.
* Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis).
* Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).
* A known allergy to any component of the alpha (1,3) galactosyltransferase tumor vaccine or cell lines from which it is derived.
* Concurrent therapy such as palliative radiation or opioid analgesics for tumor-associated pain.
* Anti-androgen therapy within 42 days of first treatment.
* Treatment with cimetidine within 30 days of first treatment.
* Prior splenectomy. | 37,742 |
Study Objectives
To discover if the adding of a coxib increases the efficacy of the Aromasine.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
DRUG: placebo, DRUG: Celecoxib, DRUG: Exemestane
| Inclusion Criteria:
* Femal patient aged > 18 years
* Histologically proven breast cancer
* Menopausal patient according to the following definition:
* amenorrhoea > 1 year or menopause affirmed by a rate of oestradiol or hypophyseal gonadotrophin
* surgical ovariectomy
* treatment by LHRH analog
* ovarian suppression by radiotherapy
* amenorrhoea induced by chemotherapy > 1 year
* Oestradiol and/or progesterone positive receptors
* Presence of one or several metastatic lesion:
* mesurable lesion
* bone metastase were detected by bone scintigraphy
* Patient who can have received:
* Adjuvant chemotherapy and/or hormonotherapy (Tamoxifen)
* Metastatic Treatment by chemotherapy
* PS < 2
* Adequate biological values
* Patient who has clearly given her consent by signing on informed consent form prior to participation
Exclusion Criteria:
* Patient previously treated with hormonotherapy in metastatic phase
* Antecedent of treatment with aromatase inhibitors
* local relapse (with the exception of cutaneous thoracic nodes)
* Patient with only one metastatic lesion like: pleurisy , ascites, lung Lymphangitis carcinomatosa | 27,024 |
Study Objectives
Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients.
Conditions: Sarcoma, Gastro-intestinal Stromal Tumors (GIST)
Intervention / Treatment:
DRUG: interruption of Glivec®
| Inclusion Criteria:
* Patients 18 years of age or over.* Histologically documented diagnosis of malignant GIST.* Immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases using the DAKO assay.* Performance status 0,1, 2, 3 (ECOG)* Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.0 x 109/L, platelets > 100 x 109/L.* Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 2 weeks (according to updated Invest. Brochure) following discontinuation of study drug.* Written, voluntary, informed consent.
Exclusion Criteria:
* Patient has another malignant tumor in CR<3 years (except if the other primary malignancy is inactive and not requiring active intervention). Previous basal cell skin cancer or a cervical carcinoma in situ are allowed.* Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)* Female patients who are pregnant or breast-feeding.* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.* Patients received chemotherapy within 2 weeks prior to study entry, unless the disease is rapidly progressing* Patients had a major surgery within 2 weeks prior to entry study* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.* Previous treatment with Glivec® | 30,315 |
Study Objectives
Hysterectomy for benign indication is one of the most common surgical procedures in women. Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but the proportion of laparoscopic (and robotic) hysterectomies is increasing.
This study will compare a range of clinical and subjective outcomes of vaginal vs. total laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to work as well as cosmesis, quality of life and sexual health.
Conditions: Uterine Fibroids, Uterine Leiomyoma, Abnormal Uterine Bleeding, Unspecified
Intervention / Treatment:
PROCEDURE: Hysterectomy
| Inclusion Criteria:
* benign indication for vaginal hysterectomy (e.g., abnormal uterine bleeding, fibroids, atypical endometrial hyperplasia)
* clinical exam indicates vaginal hysterectomy is feasible
* no major concomitant surgery
* able to complete questionnaires in German
Exclusion Criteria:
* uterine malignancy
* major concomitant surgery (e.g., for incontinence or prolapse)
* clinical exam indicating vaginal hysterectomy not feasible
* contraindication for surgery or laparoscopy | 32,028 |
Study Objectives
Purpose:
This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2) as a response biomarker.
Patients and Methods:
Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
Conditions: Non-Small-Cell Lung Carcinoma
Intervention / Treatment:
DRUG: ATRA, OTHER: PLACEBO
| Inclusion Criteria:
* Stage III B and IV NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* No prior cytotoxic chemotherapy for NSCLC
* Age ≥18 years, adequate laboratory measurements
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Life expectancy of >12 weeks.
Exclusion Criteria:
* Patients who had received prior chemotherapy
* Patients with other comorbid conditions | 37,552 |
Study Objectives
The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Leuprolide
| Inclusion Criteria:
* A patient for whom the physician has decided to initiate treatment with a Luteinizing Hormone Releasing Hormone (LHRH) agonist in standard clinical practice
* Biopsy-proven prostate adenocarcinoma
* Locally advanced prostate cancer with biochemical relapse radical prostatectomy and/or radiotherapy, OR hormonal treatment-naive advanced or metastatic prostate cancer patient who has not received chemotherapy and has no plans to undergo treatment with chemotherapy at study entry.
* Patient who indicates that once the study is completed, he expects having access to androgen deprivation therapy (ADT), either medical or surgical, within the local healthcare system (either through public/ private health insurance or out of pocket payment).
Exclusion Criteria:
* Patient with castrate resistant prostate cancer
* Patient who previously underwent bilateral orchiectomy
* Patient who has received prior treatment with LHRH analogues
* Prior or concomitant treatment with systemic chemotherapy. A patient where there is a likelihood to receive systemic chemotherapy should not be enrolled
* Life expectancy of < 1 year due to comorbidities
* Participation in another interventional clinical trial within one month prior to study entry or during the duration of the study
* Patient who plans to receive intermittent ADT at the time of study entry
* Patient receiving non-palliative radiotherapy within 3 months prior to study entry
* Patient receiving adjuvant ADT in combination with definitive radiotherapy
* Patient with metastatic hormonal treatment-naive prostate cancer, for whom chemo-hormonal treatment (combination of Docetaxel and ADT) is indicated.
* Patient with hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonist analogs or any of the components of ELIGARD®
* Patient with any contraindication for ELIGARD® use based on local prescribing information | 22,064 |
Study Objectives
To measure arm function and quality of life of mastectomy patients.
Conditions: Breast Cancer
Intervention / Treatment:
PROCEDURE: Arm exercises., PROCEDURE: Arm Exercises
| Inclusion Criteria:
* Patients who have been referred from UNMH to CRTC for further treatment following mastectomy/lumpectomy surgery.
Exclusion Criteria:
* Not specified | 33,005 |
Study Objectives
This is a Phase II, nonrandomized multicenter study designed to evaluate time to progression and response proportion of patients with advanced or metastatic transitional cell carcinoma of bladder receiving 6 cycles of gemcitabine, carboplatin and sorafenib and then maintenance sorafenib.
Conditions: Bladder Cancer
Intervention / Treatment:
DRUG: Gemcitabine, DRUG: Carboplatin, DRUG: Sorafenib
| Inclusion Criteria:
* Histologic documentation of diagnosis of transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
* Unresectable, locally advanced or metastatic disease
* CrCl ≥ 60 ml/min or serum creatinine < 1.5
* ≥ 4 weeks since prior RT
* ECOG Performance Status of 0 or 1 (Appendix I)
* Age ≥ 18 years of age
* Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men and women should use adequate birth control for at least 2 weeks after the last administration of sorafenib.
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
* Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
* Adequate bone marrow, liver and renal function as assessed by the following:
* Hemoglobin > 9.0 g/dl
* Absolute neutrophil count (ANC) ≥ 1,500/mm3
* Platelet count ≥ 100,000/mm3
* Total bilirubin ≤ 1.5 times ULN
* ALT and AST ≤ 2.5 times the ULN ( ≤ 5 x ULN for patients with liver involvement)
* INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
Exclusion Criteria:
* Prior treatment with systemic chemotherapy (prior intravesical chemotherapy is permitted, and adjuvant therapy is permitted if > 12 months have lapsed)
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
* Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
* History of stroke within six months
* Clinically significant peripheral vascular disease
* Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
* Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
* Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
* Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
* Active clinically serious infection > CTCAE Grade 2.
* Thrombolytic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
* Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug
* Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug
* Evidence or history of bleeding diathesis or coagulopathy
* Major surgery, significant traumatic injury within 4 weeks of first study drug
* Use of St. John's Wort or rifampin (rifampicin)
* Known or suspected allergy to sorafenib or any agent given in the course of this trial
* Any condition that impairs patient's ability to swallow whole pills
* Any malabsorption problem
* Anticipation of need for major surgical procedure during the course of the study
* Pregnant (positive pregnancy test) or lactating
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
* Serious, non-healing wound, ulcer, or bone fracture
* Inability to comply with study and/or follow-up procedures
* History of persistent gross hematuria | 37,761 |
Study Objectives
The aim of the study is a medico-economic evaluation to estimate a cost differential between three modalities of Intensity-Modulated Radiation Therapy for cancers of the prostate, cervix and anal canal with pelvic lymph node irradiation : treatment with helical Tomotherapy and dynamic arc therapy using two different technologies: RapidArc or VMAT.
Conditions: Prostate Cancer, Cervical Cancer, Anal Canal Cancers
Intervention / Treatment:
RADIATION: Intensity-Modulated Radiation Therapy
| Inclusion Criteria:
* WHO performance index ≤ 2
* Age > 18 years
* histologically proven carcinoma: Anal canal cancer locally advanced (> 4 cm and / or N1 to N3) under irradiation on pelvic and inguinal lymph nodes with concurrent chemotherapy. The boost with brachytherapy are accepted Prostate cancer with pelvic lymph nodes and radiation or hormone therapy Cervical Cancer under a purely medical treatment involving irradiation on pelvic lymph nodes and primary tumor with concurrent chemotherapy without surgery. The Boost by external radiotherapy or brachytherapy are accepted.
* The investigator must ensure that the patient has not expressed its opposition to participate in this study. The signing of a consent form is optional;
Exclusion Criteria:
* History of invasive cancer other than basal cell carcinomas.
* Indication of re-irradiation
* para-aortic radiotherapy associated with pelvic irradiation.
* post-operative radiotherapy.
* geographical distance | 30,423 |
Study Objectives
This study aims to evaluate the prognostic value of circulating tumour cells (CTC) in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy due to gastrointestinal cancers that have spread to the peritoneum.
Conditions: Circulating Tumor Cell, Peritoneal Metastases, Hyperthermic Intraperitoneal Chemotherapy
Intervention / Treatment:
DIAGNOSTIC_TEST: iCellate
| Inclusion Criteria:
* Peritoneal metastases being treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Exclusion Criteria:
* None | 37,555 |
Study Objectives
To determine the safety and immunogenicity profile of two (2) different doses of the vaccine DPX-0907 to treat breast, ovarian and prostate cancer.
Conditions: Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms
Intervention / Treatment:
BIOLOGICAL: DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG
| Inclusion Criteria:
* Patients with stage III or IV ovarian cancer who have completed a course of platinin-based cytotoxic therapy after debulking surgery with evidence of a complete or partial response by radiological imaging. Patients with metastatic ovarian cancer who have stable disease for greater than 3 months after completion of first-line therapy.
* Patients with stage IV breast cancer who have received at least 1 course of hormonal or cytotoxic therapy for metastatic cancer. Patients must be off cytotoxic therapy with stable disease or better for 3 months or greater duration. Patients may have stable disease and still be on hormonal therapy.
* Patients with prostate cancer who have failed at least 1 course of an accepted hormonal therapy. Specifically prostate cancer patients must have castrate testosterone levels (< 50 ng/dl) and 2 PSA values higher than the previously documented baseline at least 3 weeks apart or evidence of increases in measurable disease. These patients may have received previous courses of cytotoxic chemotherapy although chemotherapy naïve patients who are deemed not good candidates or who have refused cytotoxic therapy will be eligible. These patients may remain on anti-androgen therapy during the trial. Patients with evidence of progressive bone or other metastases are acceptable.
* At least 8 weeks since previous courses of an investigational biologic therapy (i.e. cancer vaccine) including active or passive immunotherapy.
* At least 30 days since localized surgery or radiotherapy.
* At least 30 days since initiation of a biphosphonate treatment.
* HLA A2 haplotype.
Exclusion Criteria:
* History of autoimmune disease, such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Patients with a remote history (greater than five years) of thyroiditis are not excluded.
* Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection such as: urinary tract infection, HIV, or antigen positive viral hepatitis.
* Previously resected brain metastases unless a CT or MRI scan of the brain shows no metastasis within 1 month of receiving DPX-0907.
* Concurrent (within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer.
* Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions.
* Serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV) or hepatic disease.
* Steroid therapy or other immunosuppressives, such as azathioprine or cyclosporin A, unless steroids are discontinued 6 weeks prior to study.
* Allergies to any component of the vaccine.
* Inability to gain venous access.
* Previous splenectomy.
* Previous lymphadenectomy in both inguinal regions.
* Pregnant or nursing mothers.
* Medical or psychological impediment or active drug or alcohol use that might preclude protocol compliance. | 13,743 |
Study Objectives
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.
In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
Conditions: Polyp of Colon, Endoscopic Mucosal Resection, Recurrent Colon Adenoma
Intervention / Treatment:
DEVICE: EndoRotor Resection
| Inclusion Criteria:
* Subjects aged ≥18 to ≤85 years.* At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length.* Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia.* Favorable anatomy that allows the investigator to access the lesion.* Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit.* Subject has been informed of the nature of the study, agrees to participate and has signed the consent form.
Exclusion Criteria:
* Inability to give informed consent.* Subject age is <18 years of age or >85 years of age.* Presence of a lesion that represents cancer or has a high chance of harboring submucosal invasive cancer.* Presence of synchronous lesions intended for resection that would require use of a concomitant resection modality* Medical reasons the procedure cannot be performed (i.e. labile blood pressure, anticoagulation laboratory levels that are too high and risk excessive bleeding, systemic infection, etc.)* Active antiplatelet therapy (Plavix , 325mg aspirin therapy) - patient off treatment for < 1 week.* Inability to undergo a procedure under propofol sedation or General Anesthesia.* Female patients who are known to be pregnant.* Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression).* Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.* Subject is participating in another study of a device, medication, biologic, or other agent within 90 days and could, in the opinion of the investigator, impact the results of this study.* Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and participating in evaluations pre- and post-treatment. | 4,146 |
Study Objectives
In haematological malignancy and in immunocompromised patients, constipation is a common symptom caused by a number of factors during treatment. In current clinical practice, an abdominal radiograph is the first imaging investigation for constipation and non specific abdominal pain to support or exclude the clinical suspicion. Children are more sensitive to radiation induced adverse effects especially in the thyroid gland and bone marrow. Immunocompromised patients are at risk of developing a second malignant neoplasm. MRI is an alternative imaging modality without ionizing radiation. Imaging the peritoneal cavity on abdominal MRI has always been challenging primarily because of bowel motion and a long acquisition time for standard T1 and T2 weighted sequences. Recent development of an ultrafast 2 dimensional FIESTA sequence developed by GE (General Electric) Healthcare based on the balanced steady state free precession (b-SSFP) pulse sequence has several advantages: motion insensitivity ( does not interfere with peristalsis), sharp edge definition and higher contrast when compared with the standard SSFSE pulse sequence. FIESTA is well suited for abdominal imaging as it produces motion- free images, allowing clear delineation of intra-peritoneal and retroperitoneal anatomy and is capable of depicting the vascular anatomy and lymph-adenopathy.There is a wide spectrum of diseases which could cause abdominal pain in our study group with constipation being the most common cause but MRI could potentially detect more serious bowel-related chemotherapy induced complications such as typhlitis, pneumatosis coli, veno-occlusive disease, pancreatitis and intra abdominal abscess, which would not be apparent on abdominal radiograph.
Conditions: Constipation
Intervention / Treatment:
DEVICE: MRI
| Inclusion Criteria:
* Patients with haematological malignancy or immunocompromise under the care of the haematology team and undergoing plain abdominal radiograph for abdominal pain as part of routine clinical care.
* Patients who can stay still in MRI
* Patient age between 6 and 18 years.
Exclusion Criteria:
* Patients who require sedation or general anesthesia.
* Those with signs of acute abdomen.
* Claustrophobic patient.
* Patient/parents who are unable to wait for MRI. | 3,798 |
Study Objectives
The purpose of this study is to see how effective the combination of the two chemotherapy drugs (carboplatin and nab-paclitaxel) are when added to a third drug, pembrolizumab.
Pembrolizumab is an investigational (experimental) drug that works by reinvigorating the immune system, allowing it to target and destroy cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA) for this type of breast cancer treatment.
Conditions: Metastatic Triple Negative Breast Cancer
Intervention / Treatment:
DRUG: Carboplatin, DRUG: Nab-paclitaxel, DRUG: Pembrolizumab
| Inclusion Criteria:
* Subjects must have histologically or cytologically confirmed metastatic triple negative breast cancer
* Subjects must have received no more than 2 prior therapies for this disease
* ECOG Performance Status 0-1
* Subjects must have normal organ and marrow function as defined below:
* Hemoglobin ≥ 10.0 g/dl
* Absolute neutrophil count ≥ 1,000/μL
* Platelet count ≥ 100,000/μL
* Total bilirubin within normal institutional limits
* AST (SGOT) ≤ 2.5 X institutional upper limit of normal
* ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
* Serum creatinine ≤ 1.5 normal institutional limits
* Life expectancy of 12 weeks or more
* Subjects must have the ability to understand and the willingness to sign a written informed consent document
* Subjects must have measurable disease per RECIST v1.1
* Subjects must be willing to undergo a preliminary biopsy of a metastatic focus for research purposes. A second post-treatment biopsy will be offered but will not be mandated
Exclusion Criteria:
* Prior treatment toxicities have not resolved to ≤ Grade 1 according to NCI CTCAE Version 4.0 (except for alopecia and neuropathy)
* Subjects receiving any other investigational agents
* Subjects with radiographically stable treated brain metastases are eligible but must not have been on steroid therapy for at least 4 weeks
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-paclitaxel, carboplatin, pembrolizumab, or other agents used in this study
* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breastfeeding women are excluded from this study
* Patients with conditions requiring immunosuppressive medications or chronic infections (including HIV infection, hepatitis B and C)
* Patients with chronic autoimmune disease
* Patients with prior therapy with antibodies that modulate T-cell function (e.g., anti-PD-1, anti-PD-L1)
* Patients with evidence of active, non-infectious pneumonia
* Patients active infection requiring intravenous systemic therapy
* Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the trial
* Patients who have received a live vaccine within 30 days prior to the first dose of pembrolizumab
* Patients with a known additional malignancy that is progressing or requires active treatment (within the last 5 years). Exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy
* Patients who have received monoclonal anti-cancer antibody within 4 weeks of first dose of study drugs
* Patients who have received chemotherapy, small molecule targeted therapy or radiation within the 2 weeks of first dose of study drugs
* Patients who have participated in MK-3475 Merck studies
* Patients with carcinomatous meningitis | 23,417 |
Study Objectives
The purpose of the study is to determine safety and tolerability of CVX-045 in patients with advanced solid tumors.
Conditions: Advanced Solid Tumors, Neoplasms, Carcinoma, Cancer, Malignancy
Intervention / Treatment:
BIOLOGICAL: CVX-045
| Inclusion Criteria:
* Confirmed advanced solid tumors unresponsive to currently available therapies, or for which there is no standard therapy.
* Adequate coagulation, liver and renal function.
* Candidate for DCE-MRI evaluation.
* ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
Exclusion Criteria:
* Evidence of bleeding problems.
* Uncontrolled hypertension.
* Certain gastrointestinal problems including fistula and abscess.
* Patients with primary brain cancer. | 31,090 |
Study Objectives
This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.
Conditions: Lymphoma, Non-Hodgkin, Lymphoma, Nonhodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
Intervention / Treatment:
BIOLOGICAL: lisocabtagene maraleucel
| Inclusion Criteria:
* Confirmation of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS; de novo or transformed follicular lymphoma \[tFL\]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma \[DHL/THL\]), and follicular lymphoma Grade 3B per WHO 2016 classification
* Previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD20-targeted agent
* Subjects must be deemed ineligible for both high-dose chemotherapy and hematopoietic stem cell transplant (based on age, performance status and/or comorbidities) while also having adequate organ function for CAR T cell treatment.
* Positron emission tomography (PET)-positive disease
* Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
* ECOG performance status of 0, or 1, or 2
* Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line)
* Subjects must agree to use appropriate contraception
* Subjects must agree to not donate blood, organs, semen, and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy
Exclusion Criteria:
* Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
* History of another primary malignancy that has not been in remission for at least 2 years.
* Previous treatment with CD19-targeted therapy, with the exception of prior lisocabtagene maraleucel treatment in this protocol for subjects receiving retreatment
* Active hepatitis B or hepatitis C infection at the time of screening
* History of or active human immunodeficiency virus (HIV) infection at the time of screening
* Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or lisocabtagene maraleucel administration
* History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
* History or presence of clinically relevant CNS pathology
* Pregnant or nursing women
* Subject does not meet protocol-specified washout periods for prior treatments
* Prior hematopoietic stem cell transplant
* Progressive vascular tumor invasion, thrombosis, or embolism
* Venous thrombosis or embolism not managed on stable regimen of anticoagulation
* Uncontrolled medical, psychological, familial, sociological, or geographical conditions | 5,652 |
Study Objectives
This phase I trial is studying the side effects and best dose of flavopiridol when given together with vorinostat in treating patients with relapsed or refractory acute leukemia or chronic myelogenous leukemia or refractory anemia. Flavopiridol and vorinostat may cause leukemia cells to look more like normal cells, and to grow and spread more slowly. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving flavopiridol together with vorinostat may be an effective treatment for leukemia or refractory anemia.
Conditions: Blastic Phase Chronic Myelogenous Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts, Relapsing Chronic Myelogenous Leukemia, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: alvocidib, DRUG: vorinostat
| Inclusion Criteria:
* Diagnosis of one of the following:
* Relapsed or refractory acute leukemia (acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\], or acute leukemia unclassifiable) following at least one prior systemic treatment
* Acute leukemia in a patient 60 years or older (no requirement for prior treatment)
* Acute leukemia that has evolved from a prior myelodysplastic syndrome
* Chronic myelogenous leukemia (CML) in blast crisis following prior imatinib mesylate therapy
* Refractory anemia with excess blasts-2 (RAEB-2)
* No known CNS leukemia
* ECOG performance status 0-2
* WBC < 50,000µL
* Hydroxyurea and/or leukaphereses may be used to lower WBC
* Creatinine =< 1.5 times upper limit of normal (ULN) OR creatinine clearance >= 50 mL/min
* Total bilirubin =< 2 times ULN
* AST/ALT =< 2.5 times ULN
* QTc interval =< 0.470 seconds
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No other condition that would preclude study participation
* At least 3 weeks since prior treatment (expect leukaphereses)
* No valproic acid therapy within the past 2 weeks
* No prior autologous or allogeneic bone marrow or stem cell transplantation
* No hydroxyurea use within the past 24 hours
* No concurrent treatment with other anti-cancer agents or investigational agents | 15,529 |
Study Objectives
Background
After the emergence of Covid-19 in China, Hubei Province, the epidemic quickly spread to Europe. France was quickly hit and the Croix-Rousse hospital at the Hospices Civils de Lyon was one of the first French university hospital to receive patients infected with Sars-COV2. The predicted massive influx of patients motivated the cancellation of all elective surgical procedures planned to free hospitalization beds and to free intensive care beds. Nevertheless, patients who had to be canceled had to be properly selected to avoid a life threatening. The retained surgical indications were surgical emergencies, oncologic surgery and organ transplantation.
The objective was to describe the organization of the Croix-Rousse hospital to allow the continuation of these surgical activities while limiting the exposure of patients to the Sars Cov2.
Conditions: Digestive Cancer, Gynaecological Cancer, Head and Neck Cancer
Intervention / Treatment:
BIOLOGICAL: Screening test for covid ( RT PCR and CT Chest)
| Inclusion Criteria:
* surgical management
* > 18 years old
Exclusion Criteria:
* < 18 years old | 23,141 |
Study Objectives
RATIONALE: Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life of cancer survivors. Armodafinil may help relieve insomnia and fatigue in patients with cancer after chemotherapy. PURPOSE: This randomized phase II trial is studying how well cognitive behavioral therapy with or without armodafinil works in treating cancer survivors with insomnia and fatigue after chemotherapy.
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
PROCEDURE: Quality-of-Life Assessment, OTHER: Questionnaire Administration, OTHER: Placebo, PROCEDURE: Fatigue Assessment and Management, PROCEDURE: Sleep Disorder Therapy, DRUG: Armodafinil, PROCEDURE: Quality-of-life assessment, OTHER: Questionnaire Administration, PROCEDURE: Fatigue Assessment and Management, PROCEDURE: Management of Therapy, PROCEDURE: Sleep disorder therapy, PROCEDURE: cognitive assessment, PROCEDURE: Quality of Life assessment, OTHER: Questionnaire Administration, OTHER: Placebo, PROCEDURE: Fatigue assessment and management, PROCEDURE: Management of therapy and complications, PROCEDURE: Sleep disorder therapy, DRUG: Armodafinil, PROCEDURE: Cognitive Assessment, PROCEDURE: Quality of Life Assessment, OTHER: Questionnaire Administration, PROCEDURE: Fatifue assessment and management
| Inclusion Criteria:
* Have a diagnosis of cancer
* Be able to understand written and spoken English
* Be able to swallow medication
* Have preferred sleep phase between 7:30 pm and 11:00 am
* Be willing to discontinue any medications /OTCs/Herbals for sleep for the 11-week study period
* Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted
* Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment
* At least one month must have passed since completion of chemotherapy and/or radiation treatment
* Report insomnia on the SDS-CL at a frequency of at least 3 days a week
Exclusion Criteria:
* Have ever taken modafinil or armodafinil had CBT-I therapy (CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component)
* Have an unstable medical or psychiatric illness (Axis I- current or within the last 5 years)
* Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension
* Be presently taking an anticoagulant or a corticosteroid
* Have taken amphetamines (e.g., methylphenidate, pemoline \[Cylert\] or similar psycho stimulants) within the past 30 days
* Be currently pregnant or nursing
* Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score >= 2 or an Alcohol Use Disorders Identification Test (AUDIT) score >= 13
* Have surgery planned within the study period
* Have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the "Often" or "Frequently" level
* Have serious RLS/PLMs indicated by endorsing two or more items associated with RLS/PLMs on the Sleep Disorders Symptom Check at the "Frequently" level | 21,858 |
Study Objectives
The main purpose of this study is to determine the potential clinical utility of PET imaging using the radiotracer \[C-11\]alpha-methyl-L-tryptophan in the diagnosis, differentiation and monitoring of various brain tumors, both before and after initial treatment. We will also study mechanisms and clinical significance of abnormal brain tumor tryptophan metabolism using resected tumor tissues.
Conditions: Brain Tumors
Intervention / Treatment:
| Inclusion Criteria:
* Clinical and MRI diagnosis of an intracranial lesion suspicious for a brain tumor, including primary and metastatic tumors, or a possible residual or recurrent brain tumor (based on clinical imaging); or history of glioma treatment with chemoradiation, even if no definite progression is found on clinical MRI.* Age ≥13 years.
Exclusion Criteria:
* Severe increased intracranial pressure, status epilepticus, or other symptoms requiring emergency or urgent intervention.* Resective surgery within 2 months prior to the PET scan (acute/subacute post-surgical inflammatory changes may cause false positive increases on AMT PET).* Positive pregnancy test (because of radiation involved in PET scanning). | 12,016 |
Study Objectives
The purpose of this study is to evaluate the safety and efficacy of weekly nab-paclitaxel for a second-line treatment in elderly subjects, 70 years of age or greater, with non-small cell lung cancer (NSCLC)
Conditions: Non Small Cell Lung Cancer (NSCLC)
Intervention / Treatment:
DRUG: Nab-Paclitaxel
| Inclusion Criteria:
* Signed written informed consent
* Male or female patient
* Greater than or equal to 70 years of age
* Diagnosis of NSCLC histologically or cytologically confirmed
* Internal Association for the Study of Lung Cancer Version 7 Stage IV disease or recurrence after prior surgery or radiotherapy
* Progression following one line of prior chemotherapy consisting of a platinum agent plus a standard cytotoxic partner agent other than a taxane, typically pemetrexed gemcitabine or vinorelbine
* A single agent non cytoxic regimen if the patient has a molecular change that the non cytotoxic regimen would be expected to be efficacious for epidermal growth factor receptor (EGFR) mutation for erlotinib and (EML4) anaplastic lymphoma kinase (ALk) or ROS1 for crizotinib
* Eastern Cooperative Oncology Group performance status 0 to 2
* Adequate organ and bone marrow function as defined by
* Absolute neutrophil count greater than or equal to 1500 cells/mm3
* Creatinine less than or equal to 1.5 mg dL
* Total bilirubin less than or equal to 1.5 mg dL
* Alkaline phosphatase less than or equal to 2.5 x upper limit of normal
* Alanine aminotransferase less than or equal to 2.5 x upper limit of normal
* Aspartate aminotransferase less than or equal to 2.5 upper limit of normal
* Recovered from all reversible toxicities related to their previous treatment to less than or equal to grade 1 or baseline
* Patients must have equal to grade 2 pre existing peripheral neuropathy
* Women of childbearing potential and sexually active men must agree to use effective contraception prior to study entry for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method as per standard of care
* Negative serum or urine bhCG pregnancy test at screening for patients of childbearing potential
* Patients with brain metastases may participate if they have undergone appropriate treatment for the lesions are at least two weeks post treatment without evidence for post treatment progression have no significant neurologic symptoms and no longer require steroids for the reason of brain metastases. Patients with symptoms suggestive of central nervous system (CNS) metastases should be evaluated with imaging prior to study participation
Exclusion Criteria:
* Prior taxane therapy for any indication
* Less than 3 weeks elapsed since prior exposure to chemotherapy
* Pre existing neuropathy greater than grade 1
* Other active invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years localized squamous cell carcinoma of the skin basal cell carcinoma of the skin, carcinoma in situ of teh cervix or other malignancies requiring locally ablative therapy only will not result in exclusion
* Concomitant anticancer therapy immunotherapy or radiation therapy within prior 4 weeks
* Have received treatment within the last 30 days prior to study entry with any drug that has not receive regulatory approval for an indication at the time of study entry
* Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring IV antibiotics symptomatic congestive heart failure unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements
* Pregnant women are excluded due to the potential for teratogenic or abortifacient effects of nab paclitaxel because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued prior to participation of the mother on study
* Known hypersensitivity to protein bound paclitaxel
* Any other concurrent condition that in the investigators opinion would jeopardize compliance with the protocol | 2,942 |
Study Objectives
The goal of this clinical research study is to learn if using Elitek (rasburicase) for 2 cycles can help to control or prevent TLS better than 1 cycle of rasburicase and 1 cycle of allopurinol. The safety of this treatment will also be studied.
Conditions: Leukemia, Lymphoma
Intervention / Treatment:
DRUG: Rasburicase, DRUG: Allopurinol
| Inclusion Criteria:
* Patients that are high risk for TLS or potential/intermediate risk for TLS as described below: (a) High risk: Hyperuricemia of malignancy (Uric acid levels >7.5); or diagnosis of very aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, CML in blast crisis; high grade myelodysplastic syndrome only if they have >10% bone marrow blast involvement and given aggressive treatment similar to acute myeloid leukemia (AML). (b) Potential risk: Diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: lactate dehydrogenase (LDH) >= 2 x upper limit of normal (UNL); Stage III-IV disease; Stage I-II disease with at least 1 lymph node/tumor > 5 cm in diameter. For patients with potential/intermediate risk for TLS- Only those planned to receive alternating regimens (or non-standard regimens) in 2 cycles (example; R-Hyper-central venous access device (CVAD) alternating with MTX/ARA-C) will be eligible.* Eastern Cooperative Oncology Group (ECOG) performance status 0-3.* Negative pregnancy test (females of child bearing potential) within <= 1 week of rasburicase dose and use of efficient contraceptive method (both males and females). Pregnancy test may be performed on serum (HCG) or urine (HCG).* Signed written informed consent approved by the Institutional Review Board obtained prior to study entry.
Exclusion Criteria:
* Prior H/O severe allergy or asthma requiring active treatment.* Patients with mantle cell lymphoma (MCL) with stage 1 or 2 disease.* Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase.* Pregnancy or lactation.* Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.* Known history of hemolysis and/or methemoglobinemia.* Previous therapy with urate oxidase.* Conditions unsuitable for participation in the trial in the Investigator's opinion.* Unwillingness to comply with the requirements of the protocol.* Use of allopurinol within 72 hours of the study entry. | 35,620 |
Study Objectives
In this study, we intend to divide the subjects who have been confirmed recurrent HCC into two groups: Group A: treatment with pure surgery or Group B: treatment with pure radio frequency. We will compare the non-tumor survival time, long-term survival rate between the two groups, summarize the merits and demerits of both groups, and try to establish a standardized therapy and treatment for the this kind of patients through prospective studies on the molecular biological difference of pathological samples between the first and second surgeries.
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
OTHER: PRFA or PMCT, PROCEDURE: surgery
| Inclusion Criteria:
* 20\~60 years old;* diagnosed HCC pathologically, and confirmed recurrent HCC through ultrasonic B, CT, MRI or DSA test;* has a good condition in vital organs such as heart, lung, and kidney;* has a good liver function: Child A level, or nearly A level after hepatoprotection treatment;* solitary small cancer focus (diameter <5cm), or the number of recurrent HCC focus is no more than three and all of them grow in the same lobe of liver;* without jaundice (not including jaundice in the bile ducts), without ascites or extensive metastasis outside the liver;* without invasion to portal vein.
Exclusion Criteria:
* subjects refuse to participate in this study;* subjects cannot be followed up regularly;* subjects with severe heart, lung, kidney diseases;* subjects with liver CP level B or C, and serum creatinine ≥2×ULN;* subjects with severe bone marrow depression, such as neutrophil counting is lower than 1.5 × 109. | 345 |
Study Objectives
The purpose of this study is to determine if a single intravenous (IV) dose of palonosetron 0.25 mg plus a single IV dose of dexamethasone 8 mg is effective to prevent nausea and vomiting induced by moderately emetogenic chemotherapy in subjects with cancer.
Conditions: Neoplasms, Nausea, Vomiting
Intervention / Treatment:
DRUG: Palonosetron and Dexamethasone
| Inclusion Criteria:
* Male or female, >= 18 years of age.
* Histologically or cytologically confirmed malignant disease.
* Naive or non-naive to chemotherapy.
* Karnofsky index >= 70%.
* Scheduled to receive a single dose of at least one of the following agents administered on Study Day 1: any dose of Dactynomicin, Carboplatin, Epirubicin, Idarubicin, Ifosfamide, Irinotecan, Lomustine; or Methotrexate >250 mg/m\^2, or Cyclophosphamide <=1500 mg/m\^2, or Mitoxantrone <15 mg/m\^2, or Doxorubicin >= 20 mg/m\^2, or Citarabin > 1g/m\^2, Melphalan > 50 mg/m\^2 , oxaliplatin > 75 mg/m\^2 administered over 1 to 4 hours. The administration of the major chemotherapeutic agent (which is the most emetogenic agent according to the classification of Hesketh, et al., The Oncologist 1999, 4: 191-196) defined Study Day 1 and administration of this agent should not extend beyond 4 hours.
* Provided signed written informed consent.
* Females of childbearing potential must be using reliable contraceptive measures with a negative pregnancy test at the pre-treatment visit.
* If a patient had a known hepatic, renal or cardiovascular impairment and is scheduled to receive the above mentioned chemotherapeutic agents, he/she could be enrolled in this study at the discretion of the investigator.
* If a patient had experienced at maximum mild nausea following any previous chemotherapy regimen, he/she could be enrolled in this study at the discretion of the investigator.
Exclusion Criteria:
* Unable to understand or cooperate with the study procedures.
* Received any investigational drugs within 30 days before study entry.
* Received any drug with potential anti-emetic efficacy within 24 hours of the start of treatment or will be scheduled to receive until Study Day 5 including 5-HT3 receptor antagonists, metoclopramide, phenothiazine anti-emetics (including prochlorperazine, thiethylperazine and perphenazine), scopolamine, diphenhydramine, chlorpheniramine maleate, trimethobenzamide, all benzodiazepines except temazepam or triazolam used once nightly for sleep, haloperidol, droperidol, tetrahydrocannabinol, or nabilone, any corticosteroid including dexamethasone, hydrocortisone, methylprednisolone, prednisone (excluding topical or inhaled preparations).
* Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
* Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy.
* Ongoing vomiting from any organic etiology.
* Experienced nausea (moderate or severe) or vomiting following any previous chemotherapy. At the discretion of the investigator, a patient who experienced at maximum mild nausea following any previous chemotherapy might not be excluded from this study.
* Scheduled to receive any dose of cisplatin, carmustine, hexametilamine, dacarbazine, Mecloretamine, Streptozotocin, Procarbazine o Cyclophosphamide > 1500 mg/m\^2 or any other chemotherapeutic agent with an emetogenicity level 5 according to the classification of NCCN Guidelines v1 2005 during Study Days 2-6.
* Known contraindication to 5-HT3 receptor antagonists.
* Scheduled to receive radiotherapy of the upper abdomen or cranium during Study Day 2-6.
* QTc > 500 msec at baseline. | 31,787 |
Study Objectives
This pilot randomized clinical trial studies palliative care intervention in improving quality of life, psychological distress, and communication in patients with solid tumors receiving treatment on phase I trials. Cancer patients experience many symptoms related to treatment and the cancer itself that can be distressing and impact quality of life. Palliative care focuses on managing these symptoms and may help patients with solid tumors live more comfortably.
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
OTHER: palliative care, OTHER: palliative care, PROCEDURE: quality-of-life assessment, OTHER: survey administration
| Inclusion Criteria:
* Patients diagnosed with solid tumors who are eligible for participation in Phase I clinical trials of investigational cancer therapies
* Patients who have signed an informed consent for participation in Phase I clinical trials
* Able to read or understand English-this is included because the intervention and study materials (including outcome measures) are only in English
* Ability to read and/or understand the study protocol requirements, and provide written informed consent
Exclusion Criteria:
* Patients diagnosed with hematologic (as a population distinct from solid tumors and different trials) cancers. | 22,783 |
Study Objectives
To evaluate the diagnostic accuracy of the 18Fluor-fluorodeoxyglucose (\[18F\]FDG) in the Positron Emission Tomography/Computed Tomography (PET/CT) as compared to mediastinoscopy for staging of non-small cel lung carcinoma.
Conditions: Non-small Cell Lung Carcinoma
Intervention / Treatment:
OTHER: Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma
| Inclusion Criteria:
* Individuals with histological diagnosis or high suspicion of non-small cell lung carcinoma* Patients who previously underwent staging of the disease with CT* Clinical stages I-III AJCC 7th edition.* Patients with indication for mediastinoscopy and linfonodal biopsy* Patients without treatment for lung cancer* Patients with biochemical and haematological exams* Women of childbearing potential using contraceptive methods and negative pregnancy test* Adults with more than 18 years old.* Both genders
Exclusion Criteria:
* Pregnant women
* Patients with other types of patients | 6,420 |
Study Objectives
This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.
Conditions: Hepatocellular Carcinoma (HCC)
Intervention / Treatment:
BIOLOGICAL: Pexastimogene Devacirepvec (Pexa Vec), DRUG: Sorafenib
| Inclusion Criteria:
* Histological/cytological diagnosis of primary HCC
* Advanced stage HCC (Barcelona Clinic Liver Cancer \[BCLC\] Stage C or B per American Association for the Study of Liver Disease \[AASLD\] guidelines)
* At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography \[CT\] scan, or dynamic contrast-enhanced magnetic resonance imaging \[MRI\]), and injectable under imaging-guidance (CT and/or ultrasound)
* Child-Pugh Class A
* Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Adequate hematological, hepatic, and renal function:
* Additional inclusion criteria exist
Exclusion Criteria:
* Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
* Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
* Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
* History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
* Bulky disease patients - tumors encompassing >50% of the liver volume and / or inferior vena cava invasion
* Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids
* Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
* History of severe eczema (as determined by the Investigator) requiring medical treatment
* Additional exclusion criteria exist | 10,231 |
Study Objectives
The Sponsor is developing the test medicine, AZD6094 (Savolitinib) for the potential treatment of cancer. Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably, causing a growth called a tumour. The test medicine works to inhibit a pathway within the body which promotes tumours to grow and spread. The study involves radiolabelling (labelling the molecule with radioactive 14C) which is used to locate the molecule within the body.
The study will evaluate the absolute bioavailability of the test medicine (amount of the oral test medicine that enters the blood stream relative to the dose given into the vein), along with the mass balance (how much radioactivity can be recovered from the urine and faeces) and the rates and routes of elimination of \[14C\]savolitinib. It will also look to identify the breakdown products (metabolites) of the test medicine. The safety and tolerability of the test medicine will be assessed.
The study will consist of two parts, involving a minimum of eight healthy male volunteers. In Part one, following a high fat breakfast, volunteers will receive a single oral dose of the test medicine, followed by an intravenous infusion (solution into the vein) of radiolabelled test medicine. Volunteers will remain resident in the clinical unit until 72 hours post-oral dose.
There will then be a washout period of at least 14 days, after which the volunteers will return to the clinical unit for Part two. Volunteers will receive a single oral dose of radiolabelled test medicine as an oral solution. Blood, urine and faecal samples will be collected from volunteers whilst they are resident in the clinical unit for up to 168 hours postdose (Day 8). Volunteers will return for a follow-up visit at least 14 days after their last dose for safety assessments.
Conditions: Cancer
Intervention / Treatment:
DRUG: AZD6094 (Savolitinib) film coated tablets 600 mg, DRUG: [14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL), DRUG: [14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq)
| Inclusion Criteria:
* Provision of signed and dated, written informed consent prior to any study specific procedures.* Healthy male subjects aged 30 to 65 years at the time of signing informed consent with suitable veins for cannulation or repeated venepuncture.* Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive, as measured at screening.* Must be willing and able to communicate and participate in the whole study* Must have regular bowel movements (i.e., average stool production of ≥1 and
≤3 stools per day).* Adequate coagulation parameters, defined as: International Normalisation Ratio (INR) <1.5 x ULN and activated partial thromboplastin time (aPTT) <1.5 x ULN.* Must agree to adhere to the contraception requirements defined in Section 9.4. Subjects aged under 45 years must have had a vasectomy. Subjects must be willing to agree to not father children for a further 6 months after the study follow-up visit.
Exclusion Criteria:
* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.* History or presence of GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.* Acute diarrhoea or constipation in the 7 days before administration of IMP in the study. If screening occurs >7 days before the first study day, this criterion will be determined on first study day.* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.* Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed.* Any clinically significant abnormal findings in vital signs, as judged by the investigator.* Any clinically significant abnormalities on 12-lead ECG, as judged by the investigator. Mean resting corrected QT interval (QTcF) >450 msec on screening or pre-dose (Part 1 only) obtained from 3 ECGs or factors that may increase the risk of QTcF prolongation or any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 msec.* Any factors that may increase the risk of QTcF prolongation such as chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.* Known or suspected history of drug abuse, as judged by the investigator.* Has received another new chemical entity (defined as a compound which has not been approved for marketing; including radiolabelled chemical entity) within 90 days or five elimination half-lives, whichever is longer, of the first dosing date in this study. The period of exclusion lasts for 90 days or five elimination halflives after the final dose or 1 month after the last visit, whichever is the longest. Note: subjects consented and screened, but not administered IMP in this study or a previous Phase I study, are not excluded* Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to savolitinib. Hay fever is allowed unless it is active* Evidence of current SARS-CoV-2 infection.* History of any alcohol abuse in the past 2 years.* Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).* Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 6 months prior to screening. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.* Subjects with pregnant or lactating partners.* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 \[9\], shall participate in the study.* Subjects who have been administered IMP in an 14C ADME study in the last 12 months.* Subjects with a history of cholecystectomy or gall stones.* Positive screen for drugs of abuse or alcohol at screening or on each admission to the study centre.* Subjects with estimated glomerular filtration rate \[eGFR\] of <60 mL/min/1.73m2, as measured at screening, using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation, or evidence of renal impairment in subjects with eGFR between 60 and 90 mL/min/1.73m2.* Subjects with a presence of any of the following at screening:
<LLN for haemoglobin value, WBC, neutrophil count, lymphocytes and platelet count* Total bilirubin, ALT/AST>ULN at screening.* Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.* Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the two weeks prior to the first administration of IMP or longer if the medication has a long half-life.* Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (e.g., >5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.* Involvement of any AstraZeneca, Quotient or study site employee or their close relatives.* Subjects who report to have previously received savolitinib.* Judgment by the investigator that the volunteer should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.* Subjects who cannot communicate reliably with the investigator.* Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.* Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection or previous bone marrow transplant.* History of latent or chronic infections (e.g., tuberculosis, recurrent sinusitis, genital herpes, recurrent urinary tract infections) or at risk of infection (surgery, trauma or significant infection within previous 90 days, history of skin abscesses within previous 90 days prior to first IMP dose).* Planned in-patient surgery, dental procedure or hospitalisation during the study.* Failure to satisfy the investigator of fitness to participate for any other reason. | 8,982 |
Study Objectives
Compatibility of the topotecan therapy in combination with carboplatin.
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: Hycamtin
| Inclusion Criteria:
* Age >= 18 years
* patient with ovarian cancer after primary therapy
* bone marrow function leukocytes >= 4,0 x 109/ l, platelets >= 100 109/l, hemoglobin >= 9 g/dl
* renal function creatinin <= 1,5 mg% or creatinin clearance >= 60 ml/min
* liver function bilirubin <= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range
* ECOG <= 2
* Intention of regular follow-up visits for the duration of the study
* written informed consent
Exclusion Criteria:
* any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol
* ECOG > 2
* patients with radiotherapy within the last 4 weeks | 25,271 |
Study Objectives
The goal of this clinical research study is to learn the effect of combining aprepitant with CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed or has come back. Researchers also want to see if aprepitant can help to prevent nausea and/or vomiting that may be caused by chemotherapy treatment with CHOP or R-CHOP, in these patients. CHOP consists of four drugs - Cyclophosphamide (also called Cytoxan/Neosar), Doxorubicin (or Adriamycin), Vincristine (Oncovin) and Prednisolone while R-CHOP includes Rituximab and CHOP.
Conditions: Lymphoma
Intervention / Treatment:
DRUG: Aprepitant, DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Prednisone, DRUG: Rituximab, DRUG: Ondansetron
| Inclusion Criteria:
* Newly diagnosed or relapsed lymphoid malignancy.* Patients receiving either:(1) Bolus or 48-hr infusion CHOP (cyclophosphamide 750 mg/m\^2 IV Day 1, doxorubicin 25 mg/m\^2/day IV given as bolus infusion or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg \* 5 days) OR (2) Bolus or 48-hr infusion R-CHOP (Rituximab 375mg/m\^2 on Day 1+ CHOP as above). (For patients receiving R-CHOP, CHOP may be administered starting on Day 2 at the discretion of the treating physician* Age >= to 18 years* Adequate organ function defined as serum total bilirubin <= 1.2 mg/dL, serum aspartate aminotransferase or serum glutamate oxaloacetate transaminase (SGOT) <= 60 IU/L, creatinine < 1.5 mg/dL.
Exclusion Criteria:
* Evidence of neoplastic central nervous system disease* Patients who are unable to take oral medication (e.g. due to tumor obstruction)* History of Diabetes Mellitus (Diabetes as defined by established diagnosis of diabetes currently receiving medications for the diabetes management and/or a fasting blood glucose of >= 126 mg/dL.) | 11,257 |
Study Objectives
Purpose of this study:
To establish the superiority of myomectomy versus Uterine Artery Embolization, in women with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.
Conditions: Leiomyoma
Intervention / Treatment:
PROCEDURE: myomectomy, PROCEDURE: embolisation
| Inclusion Criteria:
* Women aged ≥ 18 and ≤ 43 years old
* At least one interstitial fibroid more than 3 cm on MRIat MRI)
* with symptoms: genital bleeding, chronic pelvic pain or heaviness, anemia, or infertility > 1 year.
* With immediate desire to conceive
* without assisted reproductive indication: no tubal infertility, menstrual irregularities, hydrosalpinx, endometriosis, adenomyosis, or male infertility.
* Patient with health insurance, who can read and understand French and who has given written consent
Exclusion Criteria:
* Ongoing regnancy
* Emergency Situation
* Contraindication to surgery or uterine embolization: allergy to contrast medium , renal failure, immunodeficiency, contraindication to anesthesia, subserosal or submucosal pedunculated fibroids, fibroids with largest diameter inside of the uterine cavity | 10,240 |
Study Objectives
Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn how genistein or placebo works in patients with bladder cancer. This randomized phase II trial is studying genistein or placebo to compare how they work in patients who are undergoing surgery for bladder cancer.
Conditions: Recurrent Bladder Carcinoma, Stage I Bladder Cancer AJCC v6 and v7, Stage II Bladder Cancer AJCC v6 and v7, Stage III Bladder Cancer AJCC v6 and v7
Intervention / Treatment:
DRUG: Genistein, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, OTHER: Placebo Administration, PROCEDURE: Therapeutic Conventional Surgery
| Inclusion Criteria:
* Participants eligible for this study will have been evaluated by diagnostic office cystoscopy and found to have a bladder tumor; enrollment (signing of the consent form) must be within 60 days of pre-study cystoscopy demonstrating bladder tumor; the participant should have no evidence of distant metastasis and the primary tumor may represent either an initial diagnosis or recurrent disease of any clinical stage. Study participants must also be candidates for either subsequent cystoscopy/transurethral resection of bladder tumor (TURBT) or complete or partical cystectomy; histologic diagnosis is not required for enrollment; pre-enrollment diagnostic cystoscopy must be at least 45 days after treatment of the bladder with other agents such as BCG (participants with recurrent disease)
* ECOG performance status 0 or 1
* 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
* Ability to understand and the willingness to sign a written informed consent document
* WBC >= 3000/mm\^3
* Platelets >= 100,000mm\^3
* Hemoglobin >= 10 g/dL
* Bilirubin =< 1.4 mg/dl
* AST =< 3x normal
* Creatinine =< 2.0mg/dl
* Serum calcium =< 10.2 mg/dl,
* Amylase =< 3 x normal
* Na >= 125 and =< 155 mmol/L
* K >= 3.2 and =< 6 mmol/L
* Cl >= 85 and =< 114 mmol/L
* CO2 >= 11 mEQ/dL
* TSH within 1.3 x the upper range of normal and normal T4
* Females of child-bearing potential must have a negative pregnancy test; patients who have had a bilateral oophorectomy, hysterectomy, are greater than 1 year since their last menses, or are greater than 51 years of age are not considered to be of child-baring potential
* Participants must agree to stop soy supplements before enrolling in the study
* Patients must agree to stop taking NSAIDS before enrolling in the study; patients may, however, take cardioprotective doses of aspirin equal to or less than 81mg per day
Exclusion Criteria:
* Participant may not have received other treatment for bladder cancer between the pre-enrollment cystoscopy and subsequent surgery
* Participants may not be receiving any other investigational agents
* Participant may not have received prior pelvic irradiation for any reason
* Participant may not be receiving concurrent systemic cancer treatment for other cancers
* Participant may not be taking concurrent soy supplements while on the study medication
* Participant may not be taking concurrent NSAIDS (aspirin doses of =< 81 mg acceptable) while on the study medication
* Participant may not be taking thyroid medications
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to genistein, soy isoflavones or other allergies to soy-based products will render a participant ineligible
* Uncontrolled concurrent illness will render a participant ineligible including, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unregulated cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Women may not be pregnant or lactating; the effects of G-2535 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason 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 should inform her treating physician immediately | 2,931 |
Study Objectives
This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.
Conditions: Breast Neoplasms, Neoplasm Recurrence, Local
Intervention / Treatment:
RADIATION: APBI, RADIATION: WBI
| Inclusion Criteria:
* Life Expectation: > 5 years
* Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
* Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
* Unifocal tumour (confirmed by diagnostic MRI)
* No lymphovascular invasion
* ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells)
* Negative radial resection margins of >= 2 mm
* Surgical clips placed in the tumor bed
* Written informed consent.
Exclusion Criteria:
* Stage Ⅱ-Ⅲ
* Multifocal tumors
* Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), - - - invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive - - - lobular carcinoma
* Paget's disease of the nipple
* Underwent oncoplastic surgery of ipsilateral breast
* Underwent neoadjuvant chemotherapy or hormonal therapy
* Previous or simultaneous contralateral breast cancer
* Undergone ipsilateral chest wall radiotherapy
* Active collagen vascular disease. | 20,294 |
Study Objectives
Pain is a frequent and significant problem related to cancer-directed treatment in children. Children with cancer often cite needle procedures as the most distressing experience caused by cancer and its treatment. Recently it has been shown that an interactive humanoid robot is capable of facilitating distraction and reducing distress during childhood immunizations. Our research objectives are to: (1) assess the feasibility of implementing the robot (Medi-Port) for effectiveness testing in a future RCT (measured as implementation outcomes) and (2) determine treatment effectiveness estimates (measured as preliminary effectiveness outcomes), compared to standard medical care.
Conditions: Actively Undergoing Cancer Treatment, 4-9 Years of Age, At Least 1 Month From Diagnosis, Able to Speak and Understand English, Presenting to Clinic for at Least a 2nd Subcutaneous Port Needle Insertion
Intervention / Treatment:
DEVICE: Medi-Port, DEVICE: Medi-Port
| Inclusion Criteria:
* 4-9 years
* able to speak and understand English,
* actively undergoing cancer treatment
* presenting to clinic for at least a 2nd subcutaneous port needle insertion
* being at least 1 month from diagnosis.
Exclusion Criteria:
* visual, auditory or cognitive impairments precluding interaction with Medi-Port
* end-of-life patients
* patients who are nil per os pre-sedation. | 25,317 |
Study Objectives
The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.
Conditions: Lymphoma, Large-Cell, Diffuse
Intervention / Treatment:
DRUG: doxorubicin, DRUG: cyclophosphamide, PROCEDURE: Autologous stem cell transplantation
| Inclusion Criteria:
* Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
* Aged 18 to 60 years
* Non previously treated
* With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level
* Negative HIV, HBV and HCV serologies (except vaccination)
* With a minimum life expectancy of 3 months
* Having previously signed a written informed consent
Exclusion Criteria:
* Any history of treated or non-treated indolent lymphoma.
* T-cell lymphoma.
* Central nervous system or meningeal involvement by lymphoma.
* Any Contra-indication to any drug contained in the chemotherapy regimens.
* Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
* Serious active disease (according to the investigator's decision).
* Poor bone marrow reserve as defined by neutrophils <1.5G/l or platelets<100G/l, unless related to bone marrow infiltration.
* Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
* Childbearing woman.
* Patients previously treated with an organ transplantation. | 14,597 |
Study Objectives
The main objective of the project is to compare the effectiveness and efficiency of innovative care through the IsereADOM home-care service package versus standard care in the prevention of unplanned hospitalizations in patients with cancer treatment. In accordance with the recommendations of the French High Authority of Health (HAS), a cost-utility analysis (ACU) will be implemented
Conditions: Neoplasms
Intervention / Treatment:
OTHER: IsereADOM service package
| Inclusion Criteria:
* age > or = 18 years old at the time of signature of informed consent form
* patient with solid or hematologic tumor under treatment for cancer at the time of inclusion
* Patient managed in a medical emergency context in the 2 weeks prior to inclusion
* Patient living in Isère department (area of coverage of experiment)
* ECOG Performance index < or = 3
* patient with a life expectancy of 6 months or more
* patient with social security system
* patient able to read, write and understand French
* patient with signed informed consent
Exclusion Criteria:
* Patient included in clinical trial evaluating early stage therapeutic innovation with pharmacokinetic sampling
* Patients with follow-up in Hospitalization at Home at the end of the hospitalization for inclusion
* Patient without help "referent" in the entourage (spouse, family, friend ...)
* Patient residing in Elderly Accommodation (EHPAD) or in any other institution for dependent persons
* Patient who is homeless or living in a home that does not allow the installation of the necessary equipment
* Patient with severe cognitive impairment, defined by score at Mini Mental State Examination (MMSE)< 23/30
* Patient unable to comply (or unwilling to comply) with follow-up of the study for the duration of participation | 13,787 |
Study Objectives
This international, multicenter, prospective single arm Phase II biomarker discovery clinical trial with the primary objective of assessing the association of PFS with gene mutations, gene copy number aberrations and gene signatures in post-menopausal women with hormone receptor positive, HER2-negative metastatic or locally relapsed breast cancer whose disease has progressed after prior adjuvant endocrine therapy or one line systemic treatment, i.e., endocrine treatment or chemotherapy, administered for metastatic disease.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
DRUG: Palbociclib, DRUG: Fulvestrant
| Inclusion Criteria:
* Female gender
* Age ≥ 18 years
* Postmenopausal, defined as women with:
* Prior bilateral surgical oophorectomy; or
* Amenorrhea and age ≥ 60 years; or
* Age < 60 years and amenorrhea for 12 or more consecutive months in the absence of alternative pathological or physiological cause and FSH and serum estradiol levels within the laboratory's reference ranges for postmenopausal women.
* Endocrine resistant disease, defined as one of:
* Relapse while on adjuvant endocrine therapy;
* Relapse within 12 months after completion of adjuvant endocrine therapy;
* Progression of disease under first line endocrine therapy for metastatic and/or loco-regionally advanced breast cancer.
Note: Patient may have received one prior chemotherapy for advanced or metastatic breast cancer.
* ER positive tumor and HER2-negative tumor, as assessed locally
* ECOG Performance Status 0-1.
* Measurable or non-measurable but evaluable disease according to RECIST 1.1.
* Written Informed Consent (IC) for screening procedures.
* Written informed consent to participate in the AURORA program of BIG.
* The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
* Life expectancy >3 months.
* Hematological status:
* Absolute neutrophil count ≥ 1.5 × 109/L
* Platelet count ≥ 100 × 109/L
* Hemoglobin ≥ 9 g/dL
* Hepatic status:
* Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).
* AST and ALT ≤ 2.5 × ULN; if the patient has liver metastases, ALT and AST must be ≤ 5 × ULN.
* Glucose in normal range, or well-controlled diabetes defined as an HbA1c level ≤ 7.5%.
* Renal status:
- Creatinine ≤ 1.5 ×ULN or creatinine clearance > 60 ml/min.
* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulant.
* Ability to swallow oral medication.
Exclusion Criteria:
* Prior use of fulvestrant or any CDK inhibitor.
* More than one prior line of chemotherapy for metastatic or locally relapsed disease.
* Previous or current non-breast malignancies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.
* Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina pectoris, ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA functional classification ≥3), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
* QTc exceeding 480msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).
* Uncontrolled electrolyte disorders that can reinforce the QT-prolonging effect of the drug (e.g., hypocalcemia, hypokalemia, hypomag¬nesemia).
* Known history of HIV seropositivity. HIV screening is not required at baseline.
* Uncontrolled diabetes defined as HbA1c level > 7.5%.
* Concurrent disease or familial, sociological or geographical condition that would make the patient inappropriate for trial participation or any serious medical disorder that would interfere with the patient's safety.
* Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of Informed Consent.
* Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant.
* Treatment with an investigational agent in the 4 weeks before enrollment.
* Concurrent treatment with any of the drugs not permitted
* Adverse events (except alopecia) from previous systemic cancer therapy, radiotherapy or surgery have not recovered to CTCAE v4.0 grade 1 or resolved prior to enrollment. | 28,498 |