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

Leukemia Clinical Trial

Official title:

Phase II Study Of Bryostatin 1 (NSC 339555) And High-Dose 1-B-D-Arabinofuranosylcytosine (HiDAC) In Patients With Refractory Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00017342
• Other study ID #: CDR0000068679
• Secondary ID: P30CA016059MCV-M
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2001
• Last updated: February 26, 2010
• Start date: July 2001
• Est. completion date: June 2005

Study information

• Verified date: February 2010
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2005
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia

Intervention

Drug:
• bryostatin 1

• cytarabine

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York
United States	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,