Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy
NCT00309894 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2019-08-05
Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. GM-CSF may help ketoconazole work better by making tumor cells more sensitive to the drug. Giving ketoconazole together with hydrocortisone and GM-CSF may be an effective treatment for prostate cancer.
PURPOSE: This phase II trial is studying how well giving ketoconazole together with hydrocortisone and GM-CSF works in treating patients with progressive prostate cancer after hormone therapy.
Conditions
Interventions
- BIOLOGICAL
-
sargramostim
- DRUG
-
ketoconazole
- DRUG
-
therapeutic hydrocortisone
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Charles Ryan, MD · University of California, San Francisco
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Max Age
- 120 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-04-30
- Primary Completion
- 2007-11-30
- Completion
- 2007-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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