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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bryostatin 1; Cytarabine

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