Leukemia Clinical Trial
Official title:
IL-2 Infusion in AML Patients After Autologous Bone Marrow Transplant: A Pediatric Oncology Group Wide Phase I Trial
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill more cancer
cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating children who
have undergone bone marrow transplantation for acute myeloid leukemia.
OBJECTIVES: I. Determine the maximum tolerated dose of interleukin-2 after autologous bone
marrow transplantation in pediatric patients with acute myeloid leukemia. II. Determine
toxic effects of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive interleukin-2 (IL-2)
subcutaneously on days 1-7, 9-14, and 16-22. On days 8 and 15, patients receive IL-2 IV over
2 hours. Treatment repeats every 28 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity. Cohorts of 6-9 patients receive escalating doses of
IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 or 2 of 9 patients experience dose-limiting toxicity.
Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-27 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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