Temsirolimus and Vorinostat in Treating Patients With Metastatic Prostate Cancer
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Roswell Park Cancer Institute
- Study ID
- NCT01174199
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Adenocarcinoma of the Prostate
- Hormone-resistant Prostate Cancer
- Prostate Cancer
- Recurrent Prostate Cancer
- Stage IV Prostate Cancer
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- vorinostat — DRUGGiven orally
- temsirolimus — DRUGGiven IV
- laboratory biomarker analysis — OTHERCorrelative study
- positron emission tomography/computed tomography — PROCEDUREPET scan
Study Details
RATIONALE: Temsirolimus and vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus together with vorinostat may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus and vorinostat in treating patients with metastatic prostate cancer.
Key Dates
- Start date
- Feb 29, 2012
- Status verified
- Sep 2022
- Primary completion
- Aug 31, 2015
- Completion
- Aug 31, 2016
Study Design
- Enrollment
- 13 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm IPatients receive oral vorinostat once daily on days 1-14 and temsirolimus IV on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Frequencies of DLT and toxicity [ Time Frame: 4 yrs ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Sydney Kimmel Comprehensive Center at John Hopkins | Baltimore | Maryland | 21287 | - |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | - |
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