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.
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
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
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.
- 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.
- History of an antecedent hematologic malignancy such as myelodysplastic syndromes
- 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.