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Sponsors and Collaborators: |
Children's Cancer Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002812 |
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 and giving the drugs in different combinations may kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination chemotherapy treatment with more intensive combination chemotherapy in treating children with acute lymphocytic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: idarubicin Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | TREATMENT OF PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA WITH UNFAVORABLE FEATURES: A PHASE III GROUP-WIDE STUDY |
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Acute lymphocytic leukemia (ALL) with M3 bone marrow No FAB L3 morphology CNS or overt testicular leukemia at diagnosis allowed High risk status 10-21 years old with any white blood count (WBC) 1-9 years old with WBC of 50,000/mm3 or greater
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: No prior therapy for ALL except: Emergency therapy for blast crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration Biologic therapy: Not specified Chemotherapy: Intrathecal cytarabine or methotrexate allowed at diagnostic lumbar puncture Induction therapy must begin within 72 hours after intrathecal injection Endocrine therapy: At least 1-2 months since prior prednisone, for less than 48 hours, for reactive airway disease Inhalational steroids allowed Radiotherapy: Not specified Surgery: Not specified
Study Chair: | Nita L. Seibel, MD | Childrens Research Institute |
Study ID Numbers: | CDR0000064953, CCG-1961 |
Study First Received: | November 1, 1999 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00002812 |
Health Authority: | United States: Federal Government |
untreated childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia |
Dexamethasone Asparaginase Prednisone Daunorubicin Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Thioguanine Vincristine Cyclophosphamide 6-Mercaptopurine |
Doxorubicin Folic Acid Pegaspargase Leukemia Lymphatic Diseases Idarubicin Methotrexate Lymphoproliferative Disorders Lymphoma Cytarabine Dexamethasone acetate |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Reproductive Control Agents Antibiotics, Antineoplastic Hormones Therapeutic Uses Abortifacient Agents |
Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Gastrointestinal Agents Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Glucocorticoids Immunosuppressive Agents Antiviral Agents |