Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
Official Title: A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
Study ID: NCT00006095
Study Description
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.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Center and Beckman Research Institute, City of Hope, Duarte, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Contact Details
Name: Cynthia S. Kretschmar, MD
Affiliation: Floating Hospital for Children at Tufts - New England Medical Center
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
