Trial of GM-CSF Given in Combination With Ketoconazole and Mitoxantrone in Patients With Progressive Prostate Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

August 31, 2008

Study Completion Date

September 30, 2008

Conditions
Prostatic Neoplasms
Interventions
DRUG

GM-CSF

GM-CSF will be administered as a subcutaneous injection at a dose of 250mcg/m2/d (maximum 500 mcg) on weeks 2 and 3 each 21 day cycle (total of 14 days).

DRUG

Ketoconazole

Ketoconazole will be administered daily at a dose of 400 mg po tid (either 1 hour before or 2 hours after meals), ascorbic acid 250 mg po tid (given with ketoconazole) and replacement doses of hydrocortisone (20 mg po in the morning and 10 mg po in the evening).

DRUG

Mitoxantrone

Mitoxantrone will be given at dose of 12 mg/m2 every 3 weeks, up to a maximum cumulative dose of 140 mg/m2

Trial Locations (1)

77030

Baylor College of Medicine - Methodist Hospital, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

The Methodist Hospital Research Institute

OTHER