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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Myelogenous Leukemia

Intervention / Treatment
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* Drug: cytosine arabinoside (ara-C)
* Drug: daunomycin
* Drug: interleukin-2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cytosine arabinoside (ara-C)|nan|
|Drug: daunomycin|nan|
|Drug: interleukin-2|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of continuous infusion IL-2 with intermittent IL-2 boluses in patients with AML who have received 3 cycles of post-remission intensification therapy with high-dose ara-C |  |  | 
| To assess additional immunologic effects of IL-2 |  |  | 
| To obtain preliminary data regarding the rate of disease relapse |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, acute myelogenous leukemia, cytarabine, interleukin-2