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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003178 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of idarubicin and cladribine in treating children who have recurrent acute myeloid leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Biological: filgrastim Drug: cladribine Drug: idarubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Idarubicin and Cladribine in Recurrent and Refractory Acute Myeloid Leukemia: A POG Phase II Study |
Study Start Date: | April 2000 |
OBJECTIVES:
OUTLINE: Patients are stratified according to disease characteristics (primary or secondary acute myeloid leukemia (AML) with first untreated relapse vs primary refractory AML). (Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of 04/02/02)
Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days.
Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator. Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 51-102 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Craig A. Hurwitz, MD | Maine Children's Cancer Program at Barbara Bush Children's Hospital |
Study ID Numbers: | CDR0000065993, COG-P9720, POG-9720 |
Study First Received: | June 2, 2000 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00003178 History of Changes |
Health Authority: | United States: Federal Government |
recurrent childhood acute myeloid leukemia childhood acute myeloblastic leukemia without maturation (M1) childhood acute myeloblastic leukemia with maturation (M2) childhood acute promyelocytic leukemia (M3) childhood acute myelomonocytic leukemia (M4) |
childhood acute monoblastic leukemia (M5a) childhood acute monocytic leukemia (M5b) childhood acute erythroleukemia (M6) childhood acute megakaryocytic leukemia (M7) childhood acute minimally differentiated myeloid leukemia (M0) |
Cladribine Leukemia, Monocytic, Acute Immunologic Factors Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Immunosuppressive Agents Recurrence Leukemia, Myelomonocytic, Acute |
Acute Myeloid Leukemia, Childhood Anti-Bacterial Agents Leukemia Idarubicin Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Leukemia, Erythroblastic, Acute Leukemia, Promyelocytic, Acute Acute Promyelocytic Leukemia Di Guglielmo's Syndrome |
Cladribine Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid Leukemia, Myeloid, Acute |
Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Leukemia Neoplasms Idarubicin Therapeutic Uses |