Spots Global Cancer Trial Database for A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
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Trial Identification
Brief Title: A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
Official Title: A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias.
Study ID: NCT00315705
Study Description
Brief Summary: Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted. The purpose of the phase 1 portion of this study was to determine if clofarabine added to a combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the phase 2 portion of the study was to measure the effectiveness of the combination therapy in children with ALL.
Detailed Description:
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Alabama, Birmingham, Alabama, United States
Children's Hospital of Los Angeles, Los Angeles, California, United States
Rady Children's Hospital, San Diego, California, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Children's Memorial Hospital, Chicago, Illinois, United States
St. Vincent Children's Hospital, Indianapolis, Indiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
New York School of Medicine, New York, New York, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Contact Details
Name: Medical Monitor
Affiliation: Genzyme, a Sanofi Company
Role: STUDY_DIRECTOR
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