Acute Myeloid Leukemia Clinical Trial
Bryostatin 1 and Cytarabine in Treating Patients With Relapsed Acute Myelogenous Leukemia
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 with cytarabine in treating patients who have relapsed primary acute myelogenous leukemia.
Full Description
OBJECTIVES:
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 regimen.
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed primary acute myelogenous leukemia (AML) in first relapse after a remission of at least 3 months duration
No secondary AML, including the following:
Therapy-related AML
AML arising from myelodysplastic syndromes or similar hematological conditions
No Philadelphia chromosome or other evidence of a (9;21) translocation
Ineligible for potentially curative allogeneic stem cell transplantation
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
Zubrod 0-2
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN) (patients with Gilbert's disease or unconjugated hyperbilirubinemia may have bilirubin no greater than 3.0 mg/dL with conjugated bilirubin no greater than 0.5 mg/dL)
AST/ALT no greater than 2 times ULN
Renal:
Creatinine no greater than 1.5 times ULN
Pulmonary:
No clinically significant pulmonary disease
Other:
No clinically significant cytarabine-related cerebellar toxicity
No nonmalignant systemic disease that causes poor medical risk
No active, uncontrolled, serious infection
No medical condition that would preclude study participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Disease Characteristics
No prior allogeneic stem cell transplantation
Chemotherapy:
At least 2 weeks since prior systemic chemotherapy (24 hours for hydroxyurea) and recovered
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
Not specified
Other:
Recovered from all prior therapy
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There are 4 Locations for this study
New York New York, 10021, United States
New York New York, 10032, United States
Houston Texas, 77030, United States
Richmond Virginia, 23298, United States
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