NCT00136448

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

High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 patients who enter a remission status and have preserved liver and kidney function will then receive 3 cycles of post-remission therapy that will consist of high-dose cytarabine at a dose of 3000 mg/m2 every 12 (q12) hours on days 1, 3 and 5 (total of 6 doses). Patients who are still in remission will receive interleukin-2 (IL-2) upon count recovery at a dose of 8.1 X 10\^5 U/m2/day by continuous infusion for 10 weeks. In addition, patients will receive bolus IL-2 at a dose of 6 X 10\^5 U/m2 by intravenous bolus weekly for 6 doses through day 63. Patients will be seen on a weekly basis while on treatment for examination and bloodwork. At the end of treatment, patients will have a physical exam and bloodwork performed monthly for two years, then 4 times per year for two years.

Conditions

• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	cytosine arabinoside (ara-C)
DRUG	daunomycin
DRUG	interleukin-2

Timeline

• Start date: 1993-02-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2005-08-29
• Last updated: 2011-03-10

Locations

1 site across 1 country: United States