Evaluation of the activity of temsirolimus with FLT-PET in patients with renal cell cancer - temsirolimus-RCC-imaging
- Conditions
- advanced (stage IV or recurrent disease) RCC
- Registration Number
- EUCTR2009-012802-38-NL
- Lead Sponsor
- niversity Medical Centre Nijmegen St Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1.This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have received at least one prior angiogenesis inhibitor for their disease.
2.Subjects must have a Karnofsky performance status = 70.
3.Subject must have at least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter = 10-mm when measured by spiral computerized tomography (CT, 5-mm slice thickness contiguous)
4.Age = 18 years.
5.Absolute neutrophil count (ANC) = 1.5 x 109/L (1500 cells/mm3), platelet count = 100 x 109/L (100,000 cells/ mm3), hemoglobin = 8.0 g/dL (5.0 mmol/L).
6.Adequate renal function (serum creatinine = 1.5 times the ULN) or creatinin clearance of = 50 ml/min
7.Adequate hepatic function (bilirubin = 1.5 times the ULN, aspartate transaminase (AST) = 3 times the ULN [= 5 times the ULN if liver metastases are present]).
8.Fasting serum cholesterol = 350 mg/dL (9.0 mmol/L), triglycerides = 400 mg/dL (4.56 mmol/L).
9.Subjects receiving cytochrome P450 (CYP) 3A4 inducers or inhibitors must be on stable doses for at least 1 week prior to randomization.
10.Life expectancy of at least 8 weeks.
11.Negative pregnancy test for female patients of childbearing potential
12.Women and men enrolled into this trial must use adequate birth control measures during the course of the trial.
13.Signed and dated written informed consent form
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
1.Subjects with central nervous system (CNS) metastases. Subjects with a prior history of CNS metastases will be eligible if the screening magnetic resonance imaging (MRI)/CT (with contrast) indicates no residual disease.
2.Prior investigational therapy/agents within 2 weeks of randomization.
3.Prior treatment with a mTOR inhibitor
4.History of other prior malignancy in past 5 years, other than basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
5.Not recovered from prior surgery and/or surgery or radiation therapy within 4 weeks of randomization.
6.Immunocompromised subjects, including subjects known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.
7.Active infection or serious intercurrent illness.
8.Presence of unstable angina or myocardial infarction within the previous 6 months (prior to screening), use of ongoing maintenance therapy for life-threatening arrhythmia, known pulmonary hypertension, or pneumonitis.
9.Pregnant or nursing women, women who are of childbearing potential who are not using an effective contraceptive method, or men with partners of childbearing potential who are not using an effective contraceptive method. Agree to use effective contraceptive methods, must continue for 3 months after the last dose of CCI-779. A woman of childbearing potential is defined as a woman who is biologically capable of becoming pregnant.
10.Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: - Evaluation of the FLT-PET and FDG-PET:<br>measurement of 18F-FLT-PET-signal and FDG-PET-signal, and signal changes during treatment with temsirolimus<br>correlation of 18F-FLT-PET-signal and FDG-PET before, and signal changes during treatment with treatment outcome (clinical response and PFS).<br>- Toxicity<br>- Correlation of pharmacodynamics with PET results<br>;Main Objective: Assessment of the response rate (RR) and duration of PFS after treatment with temsirolimus in heavily pre-treated metastatic RCC patients;Primary end point(s): Assessment of the response rate (RR) and duration of PFS after treatment with temsirolimus in heavily pre-treated metastatic RCC patients
- Secondary Outcome Measures
Name Time Method