Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
- Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00006095
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vincristine plus irinotecan in treating children who have solid tumors that have not responded to previous therapy.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose and dose limiting toxicity of vincristine when administered in combination with irinotecan in children with refractory solid tumors.
* Determine the safe and tolerable phase II dose of this combination regimen in this patient population.
* Determine the pharmacokinetics of this combination regimen in these patients.
* Determine the incidence and severity of other toxicities of this combination regimen in these patients.
* Determine preliminary evidence of antitumor activity of this combination regimen in this patient population.
OUTLINE: This is a dose-escalation study of vincristine.
Patients receive vincristine IV on day 2 of the first course (day 1 of subsequent courses) and days 8, 15, 22, and 29, and irinotecan IV over 1 hour on days 1-5 and 22-26. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease receive additional courses of therapy for a maximum of 1 year.
Cohorts of 3-6 patients receive escalating doses of vincristine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for this study within 1 year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vincristine sulfate 2.0 mg/m2/wk and Irinotecan irinotecan hydrochloride - Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan irinotecan hydrochloride - Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan vincristine sulfate - Vincristine sulfate 2.0 mg/m2/wk and Irinotecan vincristine sulfate -
- Primary Outcome Measures
Name Time Method Progression Free Survival Length of study
- Secondary Outcome Measures
Name Time Method Toxicity
Trial Locations
- Locations (22)
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Children's Hospital of Orange County
🇺🇸Orange, California, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Hospital Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States