Klinisk utvecklingsarbete för utvärdering av molykulärt riktad behandling vid metastaserande njurcancer- PETTO
Phase 1
Active, not recruiting
- Conditions
- Metastaserande njurcancer
- Registration Number
- EUCTR2008-003328-45-SE
- Lead Sponsor
- Sahlgrenska Universitetssjukhuset
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Patients with metastatic renal cell carcinoma in progress after treatment with Sorafenib or Sunitinib.
Patients with poor prognosis who are ase sed to have benfit from Temsirolimus treatment
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
Exclusion Criteria
Diabetes mellitus
Claustrophobia
Extreme obesety
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study if changes in FDG uptake measured by PET after one month of Temsirolimus treatment can predict a later clinical response.<br>;Secondary Objective: To study if the metabolic effect (measured FDG - PET) of temsirolimus in metastatic renalcell carcinoma is different in the different histologcical subtypes and in different metastacic sites.;Primary end point(s): Change in FDG uptake after one month treatment with Temsirolimus compared to baseline.<br>Correlation between the change in FDG uptake after one month treatment with Temsirolimus, with progression free survial and tumor response, (procent change in tumor burden from baseline according to RESIST).<br>
- Secondary Outcome Measures
Name Time Method