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

Recruiting in Palo Alto (17 mi)

+118 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this 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.

Research Team

Kimo C. Stine, MD

Principal Investigator

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

Eligibility Criteria

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 therap

Treatment Details

Interventions

• Aldesleukin (Cytokine)

Participant Groups

Group I: All patients Experimental Treatment 1 Intervention

Day 1 through day 7, days 9-14 and days 16-22: The assigned dose of IL-2 will be administered SQ. On days 8 and 15, IL-2 will be administered as a 2 hour intravenous infusion of one million units/M2 of IL-2. After day 22 there will be a 7 day rest period before beginning the next cycle. The next cycle will repeat just as above. This will be repeated for a maximum of 4 total cycles of 21 days of IL-2 therapy. The maintenance dose of IL-2 will always be the same as given during cycle one, unless there is dose limiting toxicity.

Aldesleukin is already approved in Canada for the following indications:

Approved in Canada as Proleukin for:

• Metastatic renal cell carcinoma
• Metastatic melanoma

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

Dr. Doug Hawkins

Children's Oncology Group

Chief Executive Officer since 2020

MD from University of Washington School of Medicine

Dr. Leo Mascarenhas

Children's Oncology Group

Chief Medical Officer since 2024

MD, MS from Cedars-Sinai Guerin Children’s

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School