Vinblastine and Carboplatin in Treating Young Patients With Newly Diagnosed or Recurrent Low-Grade Glioma

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors; Neurofibromatosis Type 1
• Interventions: Drug: carboplatin; Drug: vinblastine sulfate

• Registration Number: NCT00352495
• Lead Sponsor: Children's Oncology Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-13
• Study First Posted: 2006-07-14
• Primary Completion: 2011-09
• Study Completion: 2012-03
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vinblastine sulfate and carboplatin	carboplatin	The MTD of vinblastine in combination with a monthly dose of carboplatin will be determined during the first cycle of therapy. Each 4-week cycle will consist of carboplatin once every 4 weeks on day 1. Vinblastine will be given once a week for 3 weeks followed by a one week break. Doses of carboplatin and vinblastine sulfate will be assigned at study enrollment. Patients may receive eleven additional four week cycles, barring tumor progression or unacceptable toxicity. The total duration of therapy will be approximately 48 weeks.
Vinblastine sulfate and carboplatin	vinblastine sulfate	The MTD of vinblastine in combination with a monthly dose of carboplatin will be determined during the first cycle of therapy. Each 4-week cycle will consist of carboplatin once every 4 weeks on day 1. Vinblastine will be given once a week for 3 weeks followed by a one week break. Doses of carboplatin and vinblastine sulfate will be assigned at study enrollment. Patients may receive eleven additional four week cycles, barring tumor progression or unacceptable toxicity. The total duration of therapy will be approximately 48 weeks.

Primary Outcome Measures

Name	Time	Method
Acute and dose-limiting toxicities	length of study
Maximum tolerated dose and recommended phase II dose of vinblastine in combination with carboplatin	length of study
Other toxicities	length of study

Secondary Outcome Measures

Name	Time	Method
Radiographic response	length of study
Changes in diffusion/perfusion imaging	length of study

Trial Locations

Locations (21)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Children's Memorial Hospital - Chicago; 🇺🇸 Chicago, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

C.S. Mott Children's Hospital at University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

Masonic Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis; 🇺🇸 St. Louis, Missouri, United States

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center; 🇺🇸 New York, New York, United States

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