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

Phase 2
18 Years
Not Enrolling
Acute Myelogenous Leukemia

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

The primary purpose of this study is to evaluate the ability of IL-2 to generate cytotoxic and inhibitory activity against cryopreserved autologous leukemic myeloblasts obtained at the time of diagnosis.

Principal Investigator

Richard M. Stone, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

February 1993

Completion Date:

September 2007

Related Keywords:

  • Acute Myelogenous Leukemia
  • AML
  • acute myelogenous leukemia
  • cytarabine
  • interleukin-2
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Dana-Farber Cancer Institute Boston, Massachusetts  02115