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 — DRUG
    Given orally
  • temsirolimus — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative study
  • positron emission tomography/computed tomography — PROCEDURE
    PET 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 I
    Patients 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)

FacilityCityStateZIPSite coordinators
The Sydney Kimmel Comprehensive Center at John HopkinsBaltimoreMaryland21287-
Roswell Park Cancer InstituteBuffaloNew York14263-

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