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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00017342
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : March 1, 2010
National Cancer Institute (NCI)
Information provided by:
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: bryostatin 1 Drug: cytarabine Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Of Bryostatin 1 (NSC 339555) And High-Dose 1-B-D-Arabinofuranosylcytosine (HiDAC) In Patients With Refractory Leukemia
Study Start Date : July 2001
Actual Primary Completion Date : September 2004
Actual Study Completion Date : June 2005

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


  • Not specified


  • 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


  • Creatinine no greater than 1.5 times ULN


  • No clinically significant pulmonary disease


  • 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


Biologic therapy:

  • See Disease Characteristics
  • No prior allogeneic stem cell transplantation


  • At least 2 weeks since prior systemic chemotherapy (24 hours for hydroxyurea) and recovered

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • Recovered from all prior therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00017342

United States, New York
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Virginia
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Study Chair: Steven Grant, MD Massey Cancer Center

Responsible Party: Steven Grant, MD, Virginia Commonwealth University Identifier: NCT00017342     History of Changes
Other Study ID Numbers: CDR0000068679
P30CA016059 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: March 1, 2010
Last Verified: February 2010

Keywords provided by Virginia Commonwealth University:
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)

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Bryostatin 1
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic