A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas
- 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
- 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
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.
Primary Purpose: Treatment
Maximum tolerated dose and recommended phase II dose of vinblastine in combination with carboplatin
Regina Jakacki, MD
Children's Hospital of Pittsburgh of UPMC
United States: Federal Government
|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|