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

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Drug: bryostatin 1; Drug: cytarabine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00017342

CDR0000068679

P30CA016059 (U.S. NIH Grant/Contract)

MCV-MCC-4710

NCI-4710

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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