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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 2, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | March 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00009698 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia | ||||
| Official Title ICMJE | IL-2 Infusion in AML Patients After Autologous Bone Marrow Transplant: A Pediatric Oncology Group Wide Phase I Trial | ||||
| 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. |
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| 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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Leukemia | ||||
| Intervention ICMJE | Biological: aldesleukin | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 27 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | up to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, Canada, Netherlands, Puerto Rico, Switzerland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00009698 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000065574, POG-9674 | ||||
| Study Sponsor ICMJE | Pediatric Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2002 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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