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

Phase 1
21 Years
Not Enrolling

Thank you

Trial Information

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

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) Must have received
autologous bone marrow or stem cell transplantation for AML within the past 28 to 100 days
Evidence of marrow engraftment Absolute neutrophil count at least 500/mm3 for at least 2
consecutive days Platelet count at least 20,000/mm3 without transfusion support for more
than 3 days Documented M1 or M2 bone marrow within the past 7 days

PATIENT CHARACTERISTICS: Age: Under 22 at diagnosis Performance status: Karnofsky 50-100%
Life expectancy: At least 8 weeks Hematopoietic: See Disease Characteristics Hepatic:
Bilirubin no greater than 1.5 mg/dL SGPT no greater than 2 times normal Renal: Creatinine
normal OR Glomerular filtration rate at least 70 mL/min Cardiovascular: Shortening
fraction at least 27% OR Ejection fraction greater than 50% No evidence of active cardiac
disease by electrocardiogram Pulmonary: No evidence of active pulmonary disease by chest
x-ray Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception Neurologic deficits due to CNS disease must be stable within the
past 4 weeks No active viral, bacterial, or invasive fungal infection No fever No prior
hypersensitivity to interleukin-2 No greater than grade 2 mucosal toxicity

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 3 days
since prior growth factors or intravenous immunoglobulin No concurrent cytokines or growth
factors No concurrent intravenous immunoglobulin Chemotherapy: No concurrent chemotherapy
No concurrent methotrexate IV or intrathecally Endocrine therapy: At least 3 days since
prior corticosteroids No concurrent corticosteroids (except as premedication for
documented severe transfusion reactions) Radiotherapy: Not specified Surgery: Not
specified Other: At least 3 days since prior pentoxifylline or amphotericin B No
concurrent pentoxifylline No other concurrent anticancer therapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) of IL-2

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Kimo C. Stine, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Arkansas Children's Hospital at the University of Arkansas for Medical Sciences


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

September 2005

Related Keywords:

  • Leukemia
  • recurrent childhood acute myeloid leukemia
  • childhood acute myeloid leukemia in remission
  • childhood acute myeloblastic leukemia without maturation (M1)
  • childhood acute myeloblastic leukemia with maturation (M2)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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