?TWIST?. RANDOMIZED PROSPECTIVE PHASE II STUDY OF TEMSIROLIMUS WITH OR WITHOUT LOW-DOSE INTERFERON ALPHA IN METASTATIC NON-CLEAR RENAL CELL CARCINOMA: GOIRC STUDY 02/2008 - TWIST
- Conditions
- Patients with advanced non-clear Cell Renal Carcinoma.MedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinomaMedDRA version: 9.1Level: PTClassification code 10038458Term: Renal granular cell carcinomaMedDRA version: 9.1Level: PTClassification code 10038414Term: Renal cell carcinoma stage IV
- Registration Number
- EUCTR2008-000928-71-IT
- Lead Sponsor
- GRUPPO ONCOLOGICO ITALIANO DI RICERCA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Signed informed consent Histologically or cytologically documented non-clear Cell Renal Carcinoma (with centralized review of histological specimens). In the case of a mixed histology the presence of a documented component of clear cell histology <50% is mandatory. Urothelial upper urinary tract tumors are excluded. In cases with initial diagnosis of non-clear RCC of more than 2 years (RFS >2 years) a histological/cytological confirmation of renal cell carcinoma origin of actual metastases is mandatory. Metastatic measurable disease (at least one uni-dimensional measurable lesion by CT-scan or MRI) according to RECIST criteria (reported in Appendix Karnofsky performance status (KPS) ≥ 70 (KPS scale reported in Appendix) Age ≥ 18 years§ Life expectancy ≥ 3 months Prior Surgery and/or Radiation Therapy (to less or equal than 25% of the bone marrow) are allowed. However, at least 4 weeks must have been elapsed since surgery or completion of radiation therapy and the patient must has recovered from side effects ANC ≥1.5 x 109/L; PLT ≥100 x 109/L; Hb ≥ 9 g/dl Adequate hepatic function: Total bilirubin ≤1.5 times UNL*; ALT and AST ≤2.5 times UNL (≤5 UNL in presence of liver metastases) Serum creatinine ≤2.0 x the UNL. Serum cholesterol ≤350 mg/dL; serum triglycerides ≤ 300 mg/dL Patients must be accessible for treatment and follow up
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
CNS metastases Previous malignancy except for basal cell skin cancer and cervical carcinoma in situ adequately treated, or any other cancer from which the patient has been disease-free for >=5 years Any of the concomitant illness or medical condition indicated below: Serious respiratory or cardiovascular disease such as: congestive heart failure (³ NYHA Class II -refer to Appendix-); previous history (within 6 months) of myocardial infarction, angina pectoris or cardiac arrhythmias requiring anti-arrythmics (excluding beta blockers or digoxin). Active coronary artery disease, uncontrolled hypertension Unstable diabetes mellitus, significant neurological or psychiatric disorders or seizure disorder requiring medication (such as anti-epileptics). Uncontrolled hypertension (systolic pressure ³ 160 mm Hg and/or diastolic ³ 90mm Hg) while receiving chronic medication. Active clinically serious bacterial or fungal infections (> grade 2 NCI-CTC, Version 3) or active human immunodeficiency virus (HIV) infection or chronic hepatitis B or C Previous or concomitant treatment with antiangiogenic agents (e.g.: bevacizumab, sorafenib, sunitinib) or m-TOR inhibitors. Previous treatment with chemotherapy, immunotherapy (IFN and/or Interleukin-2) for advanced disease is allowed Prior isotope treatment (e.g. strontium or samarium) Participation in clinical trials with other experimental agents within 30 days of study entry or concomitant treatment with other experimental drug Use of immunosuppressive agents including systemic steroids). History of organ allograft or autologous bone marrow transplant or stem cell rescue within four months of start of study drug Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial Known or suspected allergy to the investigational agent or any agent given in association with this trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method