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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: | NCT00004932 |
RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia.
PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: imatinib mesylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of STI571 in Ph+ Leukemia |
Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral imatinib mesylate (STI571) once daily for 28 days. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study within 3.5 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Recurrent Philadelphia (Ph) chromosome-positive leukemia
Chronic myelogenous leukemia with resistance to interferon alfa with any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Martin Champagne, MD | Hopital Sainte Justine |
Study ID Numbers: | CDR0000067616, COG-P9973, POG-9973, CCG-P9973 |
Study First Received: | March 7, 2000 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00004932 History of Changes |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia relapsing chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia childhood chronic myelogenous leukemia |
Philadelphia Chromosome Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Leukemia, Myeloid, Acute Protein Kinase Inhibitors Recurrence |
Imatinib Acute Myeloid Leukemia, Childhood Leukemia Acute Myelocytic Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia |
Imatinib Leukemia Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |