Vinblastine and Carboplatin in Treating Young Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
RATIONALE: Drugs used in chemotherapy, such as vinblastine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vinblastine when given together with carboplatin in treating young patients with newly diagnosed or recurrent low-grade glioma.
Brain and Central Nervous System Tumors
Neurofibromatosis Type 1
Drug: vinblastine sulfate
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas|
- Maximum tolerated dose and recommended phase II dose of vinblastine in combination with carboplatin [ Designated as safety issue: Yes ]
- Acute and dose-limiting toxicities [ Designated as safety issue: Yes ]
- Other toxicities [ Designated as safety issue: Yes ]
- Radiographic response [ Designated as safety issue: No ]
- Changes in diffusion/perfusion imaging [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Show 21 Study Locations
|Study Chair:||Regina Jakacki, MD||Children's Hospital of Pittsburgh of UPMC|
|Investigator:||Eric Bouffet, MD, MRCP||The Hospital for Sick Children|