Phase II Study Of Bryostatin 1 (NSC 339555) And High-Dose 1-B-D-Arabinofuranosylcytosine (HiDAC) In Patients With Refractory Leukemia
18 Years
N/A
Both
Leukemia
Trial Information
Phase II Study Of Bryostatin 1 (NSC 339555) And High-Dose 1-B-D-Arabinofuranosylcytosine (HiDAC) In Patients With Refractory Leukemia
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Steven Grant, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Massey Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068679
NCT ID:
NCT00017342
Start Date:
July 2001
Completion Date:
June 2005
Related Keywords:
- Leukemia
- 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)
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
| Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
| New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
