Leukemia
Conditions
Keywords
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)
Brief 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.
Detailed 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.
Interventions
DRUGbryostatin 1
DRUGcytarabine
Sponsors
National Cancer Institute (NCI)
Virginia Commonwealth University
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed