A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) in Phase 1
The MTD was to be the highest dose level of clofarabine in combination with etoposide and cyclophosphamide that caused <= 1 of 6 participants to experience a dose limiting toxicity (DLT) with the next higher dose level having at least 2 of 3 or 2 of 6 participants experiencing a DLT. The MTD would be used as the recommended phase 2 dose (RP2D). If the MTD could not be determined, then the target dose of clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 as taken by Cohort 5 was to become the RP2D. The rating scale used is 0 = not the MTD, 1 = the MTD.
Up to Day 42 (Phase 1 portion of study)
Yes
Medical Monitor
Study Director
Genzyme
United States: Food and Drug Administration
CLO21800205
NCT00315705
March 2006
May 2010
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Children's Hospital of Alabama | Birmingham, Alabama 35233 |
Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
Children's Memorial Hospital | Chicago, Illinois 60614 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Rady Children's Hospital | San Diego, California 92123 |
Children's Hospital of Los Angeles | Los Angeles, California 90027 |
St. Vincent Children's Hospital | Indianapolis, Indiana |
New York School of Medicine | New York, New York |