Spots Global Cancer Trial Database for Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
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Trial Identification
Brief Title: Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
Official Title: A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric Patients With Relapsed Or Refractory Rhabdomyosarcoma
Study ID: NCT00055939
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating children who have relapsed or refractory rhabdomyosarcoma.
Detailed Description: OBJECTIVES: * Determine the objective response rate (complete and partial responses) in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate. * Determine the time to tumor progression in patients treated with this drug. * Determine the median survival and survival at 6 and 12 months in patients treated with this drug. * Assess pain in patients treated with this drug. * Evaluate the quantitative and qualitative toxic effects of this drug in these patients. * Evaluate the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 6 additional courses beyond CR. PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study within 1 year.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Contact Details
Name: Robert L. DeJager, MD, FACP
Affiliation: Daiichi Sankyo
Role: STUDY_CHAIR
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