Status:
COMPLETED
High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will add interleukin-2 (IL-2) to a regimen of post-remission therapy consisting of high-dose ara-C. Patients with AML in first remission will receive 3 cycles of high-dose ara-C followed by...
Detailed Description
Patients will receive standard remission induction therapy with daunorubicin at a dose of 45 mg/m2/day for 3 days and continuous infusion cytarabine at a dose of 200 mg/m2/day for 7 days. Those patie...
Eligibility Criteria
Inclusion
- Patients must have AML based on French-American-British (FAB) criteria.
- Patients must have a total bilirubin of \< 2.0 mg/dL, SGOT \< 90 IU/mL, alkaline phosphatase \< 250 U/mL and a serum creatinine \< 2.0 mg/dL.
- Age 18 years or greater.
Exclusion
- History of an antecedent hematologic malignancy such as myelodysplastic syndromes (MDS).
- Uncontrolled infection.
- History of a previous or concomitant malignancy other than non-melanoma skin cancer.
- Evidence of central nervous system (CNS) leukemia.
- Current use of corticosteroids.
- Prior treatment for AML, other than hydroxyurea.
Key Trial Info
Start Date :
February 1 1993
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00136448
Start Date
February 1 1993
End Date
September 1 2007
Last Update
March 10 2011
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115