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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: | NCT00049569 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more cancer cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and imatinib mesylate in treating children who have relapsed acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: imatinib mesylate Drug: leucovorin calcium Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Intensive Induction Therapy For Children With Acute Lymphoblastic Leukemia (ALL) Who Experience A Bone Marrow Relapse |
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute lymphoblastic leukemia (ALL) in first relapse involving the bone marrow (M3 marrow)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Elizabeth A. Raetz, MD | Mount Sinai School of Medicine |
Study ID Numbers: | CDR0000258120, COG-AALL01P2 |
Study First Received: | November 12, 2002 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00049569 |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia non-T, non-B childhood acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia |
Prednisone Leukemia, Lymphoid Hydrocortisone Leucovorin Cyclophosphamide Etoposide phosphate Leukemia Pegaspargase Methotrexate Lymphoma Etoposide Cytarabine Asparaginase |
Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Cortisol succinate Vincristine Doxorubicin Recurrence Imatinib Folic Acid Lymphatic Diseases Calcium, Dietary Hydrocortisone acetate Lymphoproliferative Disorders |
Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Antibiotics, Antineoplastic Protein Kinase Inhibitors Hormones Therapeutic Uses Vitamins |
Abortifacient Agents Micronutrients Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Vitamin B Complex Antineoplastic Agents, Hormonal Immune System Diseases Growth Substances Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |