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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004034 |
Purpose
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 |
|---|---|---|
|
Cardiac Toxicity Leukemia Quality of Life |
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 Radiation: 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 |
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000066202, DFCI-95001, DFCI-FDR001197, NCI-G99-1651 |
| Study First Received: | December 10, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004034 History of Changes |
| 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 |
|
Anti-Inflammatory Agents Prednisone Hydrocortisone Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Razoxane Methotrexate Methylprednisolone Hemisuccinate Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders |
Antineoplastic Agents, Hormonal Vincristine Glucocorticoids Doxorubicin Folic Acid Chelating Agents Hydrocortisone acetate Antineoplastic Agents, Phytogenic Acute Lymphoblastic Leukemia, Childhood Antimetabolites Leukemia, Lymphoid Immunologic Factors Folate Quality of Life Leucovorin |
|
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Razoxane Therapeutic Uses Abortifacient Agents |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Methylprednisolone Hemisuccinate Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Chelating Agents |