Phase II Study Of Bryostatin 1 (NSC 339555) And High-Dose 1-B-D-Arabinofuranosylcytosine (HiDAC) In Patients With Refractory Leukemia
- Determine the response rate in patients with primary acute myelogenous leukemia in
first relapse treated with bryostatin 1 and high-dose cytarabine.
- Determine the toxic effects of this regimen in these patients.
- Determine the relapse-free survival and overall survival of patients treated with this
OUTLINE: This is a multicenter study.
- Induction: Patients receive bryostatin 1 IV over 24 hours on days 1 and 11. Patients
also receive high-dose cytarabine IV over 3 hours every 12 hours for 4 infusions on
days 2-3 and days 9-10.
Patients who achieve a major response receive a second course of induction therapy.
- Consolidation: Patients who achieve complete remission receive bryostatin 1 IV over 24
hours on days 1 and 10 and high-dose cytarabine IV over 3 hours every 12 hours for 2
infusions on days 2 and 9. Treatment continues for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
Patients who achieve a response and subsequently relapse may receive additional induction
and consolidation therapy at the discretion of the investigator.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Steven Grant, MD
Massey Cancer Center
United States: Food and Drug Administration
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|
|Massey Cancer Center at Virginia Commonwealth University||Richmond, Virginia 23298-0037|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|