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

Completed · Phase 2

Conditions studied: Acute Myelogenous Leukemia

In brief

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.

Key facts

Study ID

NCT00136448

Run by

Dana-Farber Cancer Institute

People needed

30

Starts

1993-02-01

Expected to finish

2007-09-01

Last updated by the study team

2011-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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