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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: | NCT00537030 |
RATIONALE: Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase.
Condition | Intervention |
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Leukemia |
Drug: asparaginase-Erwinia |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase®; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic Leukemia (ALL) |
Estimated Enrollment: | 55 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive 6 doses of Erwinia asparaginase intramuscularly on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody studies.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 1 Year to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Concurrently enrolled on a frontline Children's Oncology Group treatment trial (i.e., COG-AALL0232 or COG-AALL0531, COG-AALL0331, or COG-AALL0434) at a participating institution
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Canada, Quebec | |
Montreal Children's Hospital at McGill University Health Center | Recruiting |
Montreal, Quebec, Canada, H3H 1P3 | |
Contact: Sharon Abish 514-412-4400x22219 |
Study Chair: | Wanda L. Salzer, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000566349, COG-AALL07P2 |
Study First Received: | September 27, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00537030 |
Health Authority: | Unspecified |
adult acute lymphoblastic leukemia childhood acute lymphoblastic leukemia |
Asparaginase Pegaspargase Lymphatic Diseases Leukemia Hypersensitivity Leukemia, Lymphoid |
Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoproliferative Disorders Lymphoma Acute lymphoblastic leukemia, adult |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |