Status:
TERMINATED
Trial of GM-CSF Given in Combination With Ketoconazole and Mitoxantrone in Patients With Progressive Prostate Cancer
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Bayer
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This trial represents an attempt to offer second line immunotherapy plus chemotherapy to patients who have failed prior taxane base therapy.
Detailed Description
Prostate cancer is the second leading cause of cancer death in American men. Hormonal ablation, in the form of medical or surgical castration is the cornerstone of management for metastatic prostate c...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate
- Testosterone \< 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
- Progressive disease after androgen deprivation.
- Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen.
- Karnofsky Performance Status ≥ 60%.
- One prior taxane based chemotherapy for prostate cancer. No more than two prior systemic therapies. At least four weeks have lapsed since prior therapy.
- Patients may have had prior ketoconazole, aminoglutethimide or corticosteroids for treatment of progressive prostate cancer.
- Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment. Progressive disease must be documented after discontinuation of the hormonal therapy.
- Patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
- Liver function tests (ALT, AST) less than 1.5 x upper limit of normal (ULN). The bilirubin must be within normal limits.
- ANC \>1500/µl, Platelet count \> 100,00/µl, Creatinine \<1.5 x ULN, Hemoglobin \> 8 mg/dl
- Ejection fraction ≥45%.
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00447473
Start Date
July 1 2006
End Date
September 1 2008
Last Update
March 17 2016
Active Locations (1)
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1
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States, 77030