Bryostatin 1 and Cytarabine in Treating Patients With Relapsed Acute Myelogenous Leukemia
This study has been completed.
Sponsor:
Virginia Commonwealth University
Collaborator:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00017342
First received: June 6, 2001
Last updated: February 26, 2010
Last verified: February 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: bryostatin 1 Drug: cytarabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Virginia Commonwealth University:
| Study Start Date: | July 2001 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017342
Locations
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| 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
Investigators
| Study Chair: | Steven Grant, MD | Massey Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Steven Grant, MD, Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00017342 History of Changes |
| Other Study ID Numbers: | CDR0000068679, P30CA016059, MCV-MCC-4710, NCI-4710 |
| Study First Received: | June 6, 2001 |
| Last Updated: | February 26, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Bryostatin 1 Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 21, 2013