Bryostatin 1 and Cytarabine in Treating Patients With Relapsed Acute Myelogenous Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study Of Bryostatin 1 (NSC 339555) And High-Dose 1-B-D-Arabinofuranosylcytosine (HiDAC) In Patients With Refractory Leukemia

Conditions
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Leukemia

Intervention / Treatment
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* Drug: bryostatin 1
* Drug: cytarabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bryostatin 1|nan|
|Drug: cytarabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)