A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
- Conditions
- Prostatic Neoplasm
- Registration Number
- NCT00001446
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer.
An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide.
- Detailed Description
This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer. Patients will be randomized to two different treatment arms (low dose versus high dose). An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide. Each patient that has biopsiable lesions will undergo a pretreatment biopsy of their prostate (or other site of soft tissue disease) and repeat after 2 to 6 months of treatment. Additional information will be obtained on the changes in the circulating levels of the following growth factors: bFGF, TNF, VEGF, and TGFB. Neurological complications are the primary dose-limiting toxicity anticipated with chronic thalidomide administration.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Cancer Institute (NCI)
🇺🇸Bethesda, Maryland, United States