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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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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 CenterHouston, Texas  77030-4009
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021