High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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 continuous infusion and bolus interleukin-2 (IL-2). We, the researchers at the Dana-Farber Cancer Institute, plan to evaluate the immunologic effects of such treatment in these patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Brigham and Women's Hospital
• Treatments: Cytarabine; Daunorubicin; Interleukin-2

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.