Acute Myelogenous Leukemia
Conditions
Keywords
AML, acute myelogenous leukemia, cytarabine, interleukin-2
Brief 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.
Interventions
Sponsors
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| To assess additional immunologic effects of IL-2 | — |
| To obtain preliminary data regarding the rate of disease relapse | — |
| 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 | — |
Countries
United States
Outcome results
None listed