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

Virginia Commonwealth University

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Leukemia

Interventions

bryostatin 1DRUG

cytarabineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

New York Weill Cornell Cancer Center at Cornell University

New York, New York, United States

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, United States

Data from ClinicalTrials.gov

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