A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
- 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
- Determine the pharmacokinetics of this combination regimen in these patients.
- Determine the incidence and severity of other toxicities of this combination regimen in
- 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.
Primary Purpose: Treatment
Cynthia S. Kretschmar, MD
Floating Hospital for Children at Tufts - New England Medical Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Mount Sinai School of Medicine||New York, New York 10029|
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Cancer Center and Beckman Research Institute, City of Hope||Duarte, California 91010-3000|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|Children's Hospital of Orange County||Orange, California 92668|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|Children's Mercy Hospital||Kansas City, Missouri 64108|
|Children's Hospital Medical Center - Cincinnati||Cincinnati, Ohio 45229-3039|
|Children's Hospital of Pittsburgh||Pittsburgh, Pennsylvania 15213|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|