A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas
OBJECTIVES:
Primary
- Estimate the maximum tolerated dose and recommended phase II dose of vinblastine when
given in combination with carboplatin in pediatric patients with newly diagnosed or
recurrent low-grade gliomas.
- Define and describe the acute and dose-limiting toxicities of this regimen.
- Describe the toxicities associated with repeated courses of the combination
chemotherapy regimen and the number of treatment modifications required over the course
of treatment.
Secondary
- Describe the radiographic responses in patients treated with this regimen.
- Describe changes in diffusion/perfusion imaging during study therapy.
OUTLINE: This is a multicenter, dose-escalation study of vinblastine. Patients are
stratified according to amount of prior therapy (heavily pretreated vs less heavily
pretreated).
Patients receive carboplatin IV over 30 minutes on day 1 and vinblastine IV on days 1, 8,
15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vinblastine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Maximum tolerated dose and recommended phase II dose of vinblastine in combination with carboplatin
Yes
Regina Jakacki, MD
Study Chair
Children's Hospital of Pittsburgh of UPMC
United States: Federal Government
CDR0000483184
NCT00352495
June 2006
Name | Location |
---|---|
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Children's Hospital of Orange County | Orange, California 92668 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham, Alabama 35294 |
Oregon Health and Science University Cancer Institute | Portland, Oregon 97239-3098 |