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

NCT ID: NCT00017342

Last Updated: 2010-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2005-06-30

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.

Conditions

Leukemia

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bryostatin 1

Intervention Type: DRUG

cytarabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Virginia Commonwealth University

Principal Investigators

Steven Grant, MD

Role: STUDY_CHAIR

Massey Cancer Center

Locations

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

Countries

United States

Other Identifiers

P30CA016059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCV-MCC-4710

Identifier Type: -

Identifier Source: secondary_id

NCI-4710

Identifier Type: -

Identifier Source: secondary_id

CDR0000068679

Identifier Type: -

Identifier Source: org_study_id