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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004034 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known which treatment regimen is more effective for acute lymphoblastic leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy and radiation therapy in treating children who have acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Leukemia |
Drug: asparaginase Drug: cytarabine Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: prednisolone Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate Procedure: quality-of-life assessment Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Treatment of Childhood Acute Lymphoblastic Leukemia: Grant Application Title: Erwinia Asparaginase in Childhood Acute Leukemia |
Ages Eligible for Study: | 1 Year to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically proven acute lymphoblastic leukemia (ALL) No mature B-cell ALL (i.e., surface immunoglobulin present and L3 morphology) Standard risk disease at diagnosis defined as: 1 to 9 years at diagnosis Highest pretreatment WBC less than 50,000/mm3 No blasts on CSF cytospin No T-cell markers on lymphoblasts No anterior mediastinal mass No cranial nerve palsy High risk disease defined as any patient who fails to meet all standard risk criteria at either diagnosis or at end of induction No t(8;14) (q24;q32), t(8;22), or t(2;8) T-cell surface markers and t(8;14) (q24;q11) allowed Investigational Window eligibility: At least 30 days since prior steroid therapy No concurrent emergent mediastinal radiotherapy or intubation No septic shock No concurrent intracranial hemorrhage No clinical evidence of CNS or lung leukostasis Bilirubin less than 1.4 mg/dL
PATIENT CHARACTERISTICS: Age: 1 to 17 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: Not specified Other: HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics No more than 1 week of steroids Radiotherapy: See Disease Characteristics Prior emergent radiotherapy to the mediastinum allowed Surgery: Not specified Other: Prior leukapheresis or exchange transfusion allowed, but must be completed before study
United States, Louisiana | |
Ochsner Clinic | |
New Orleans, Louisiana, United States, 70121 | |
United States, Maine | |
Maine Children's Cancer Program | |
Portland, Maine, United States, 04101 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
University of Rochester Cancer Center | |
Rochester, New York, United States, 14642 | |
Canada, Ontario | |
McMaster Division | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Canada, Quebec | |
Hopital Sainte Justine | |
Montreal, Quebec, Canada, H3T 1C5 | |
Laval University Medical Center | |
Sainte-Foy, Quebec, Canada, G1V 4G2 | |
Puerto Rico | |
San Jorge Childrens Hospital | |
Santurce, Puerto Rico, 00912 |
Study Chair: | Stephen E. Sallan, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000066202, DFCI-95001, DFCI-FDR001197, NCI-G99-1651 |
Study First Received: | December 10, 1999 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00004034 |
Health Authority: | United States: Federal Government |
untreated childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia cardiac toxicity quality of life |
Prednisone Leukemia, Lymphoid Hydrocortisone Methylprednisolone Leucovorin Quality of Life Prednisolone acetate 6-Mercaptopurine Razoxane Leukemia Methotrexate Lymphoma Cytarabine Methylprednisolone Hemisuccinate |
Asparaginase Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Cortisol succinate Methylprednisolone acetate Vincristine Doxorubicin Folic Acid Calcium, Dietary Lymphatic Diseases Prednisolone Hydrocortisone acetate Lymphoproliferative Disorders |
Antimetabolites Anti-Inflammatory Agents 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 Neuroprotective Agents Hormones Therapeutic Uses |
Vitamins Abortifacient Agents Micronutrients Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Vitamin B Complex Antineoplastic Agents, Hormonal Immune System Diseases Growth Substances Mitosis Modulators Gastrointestinal Agents Enzyme Inhibitors Antimitotic Agents Cardiovascular Agents |