A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
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.
Interventional
Primary Purpose: Treatment
Cynthia S. Kretschmar, MD
Study Chair
Floating Hospital for Children at Tufts - New England Medical Center
United States: Federal Government
CDR0000068102
NCT00006095
July 2000
Name | Location |
---|---|
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 |