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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Children's Hospital Boston University of Rochester Hamilton Health Sciences San Jorge Children's Hospital (Puerto Rico) Hospital St. Justine Maine Children's Cancer Program Oschner Clinic (New Orleans) Tulane University School of Medicine Laval University Columbia University |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00165178 |
The purpose of this study is to reduce the side-effects from anti-leukemia therapy. The therapy in this study is based upon treatment information learned from prior clinical research programs as well as from laboratory research.
Condition | Intervention | Phase |
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Acute Lymphoblastic Leukemia |
Drug: prednisone Drug: dexamethasone Drug: doxorubicin Drug: E. coli asparaginase Drug: vincristine Drug: methotrexate Drug: Leucovorin Drug: Asparaginase Drug: cytarabine Drug: Methotrexate/Hydrocortisone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Acute Lymphoblastic Leukemia in Children |
Estimated Enrollment: | 498 |
Study Start Date: | September 2000 |
Estimated Study Completion Date: | September 2010 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Patients in the "Hight Risk" group will also receive dexrazoxane.
One randomization involves the drug E. coli L-asparaginase and two ways of dosing this drug. One way is to give the same standard dose of the drug that has been administered for years. The other way is to start with a lower dose and measure the amount of the drug in the blood every 3 weeks adjusting the dose as necessary. The goal of doing this is to maintain adequate drug levels with lower doses in the hope the it may reduce some side effects of the drug.
Ages Eligible for Study: | 1 Year to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Lewis Silverman, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Lewis B. Silverman, MD ) |
Study ID Numbers: | 00-001 |
Study First Received: | September 9, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00165178 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acute lymphoblastic leukemia in children High Risk ALL Standard Risk ALL E. coli asparaginase |
Anti-Inflammatory Agents Dexamethasone Antimetabolites Prednisone Leukemia, Lymphoid Hydrocortisone Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Leucovorin Hormones Razoxane Anti-Bacterial Agents Leukemia |
Vitamins Methotrexate Micronutrients Lymphoma Dexamethasone acetate Cytarabine Acute Lymphoblastic Leukemia Asparaginase Vitamin B Complex Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Antineoplastic Agents, Hormonal Cortisol succinate Vincristine Trace Elements |
Dexamethasone Anti-Inflammatory Agents Prednisone Anti-Infective Agents Antimetabolites, Antineoplastic Hydrocortisone Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Antineoplastic Agents, Phytogenic Antimetabolites Leukemia, Lymphoid Immunologic Factors |