Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00009698
- Lead Sponsor
- Children's Oncology Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose (MTD) of IL-2 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (119)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Scroll for more (109 remaining)University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States