31
Participants
Start Date
July 31, 2006
Primary Completion Date
August 31, 2008
Study Completion Date
September 30, 2008
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).
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).
Mitoxantrone
Mitoxantrone will be given at dose of 12 mg/m2 every 3 weeks, up to a maximum cumulative dose of 140 mg/m2
Baylor College of Medicine - Methodist Hospital, Houston
Collaborators (1)
Bayer
INDUSTRY
The Methodist Hospital Research Institute
OTHER