NCT00009698

Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia

IL-2 Infusion in AML Patients After Autologous Bone Marrow Transplant: A Pediatric Oncology Group Wide Phase I Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin	Given SQ and IV

Timeline

• Start date: 1998-03-01
• Primary completion: 2001-06-01
• Completion: 2005-09-01
• First posted: 2003-12-31
• Last updated: 2013-06-28

Locations

119 sites across 6 countries: United States, Australia, Canada, Netherlands, Puerto Rico, Switzerland