Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00055939
- Lead Sponsor
- Daiichi Sankyo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸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
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States