Combination Chemotherapy in Treating Children With Progressive Brain Tumors

Recruiting in Palo Alto (17 mi)

+203 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.

Eligibility Criteria

Inclusion Criteria

Glial Tumors

Astrocytic tumors

Low grade astrocytoma (variants: fibrillary, protoplasmic, gemistocytic)

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Treatment Details

Interventions

Carboplatin (Alkylating agents)
Lomustine (Alkylating agents)
Procarbazine Hydrochloride (Alkylating agents)
Thioguanine (Anti-metabolites)
Vincristine Sulfate (Vinca alkaloids)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Regimen B (TPCV Chemotherapy)Experimental Treatment4 Interventions

Each cycle of chemotherapy consists of 4 days of oral chemotherapy (Thioguanine, procarbazine hydrochloride, Lomustine and Vincristine sulfate beginning Day 0, followed by vincristine sulfate IV on Days 14 and 28. The cycle is repeated every 6 weeks (42 days). A total of 8 cycles will be given.

Group II: Regimen A (CV Chemotherapy)Experimental Treatment2 Interventions

Induction will consist of 10 weeks of therapy (carboplatin, vincristine sulfate),followed by 2 weeks without chemotherapy. Induction should only be interrupted in the event of grade 3 neurotoxicity, grade 2 renal toxicity, grade 4 hematologic toxicity, or tumor progression. Maintenance-Four Courses (2 cycles/course) commences on Day 84 (week 12) of Induction or when peripheral counts recover with ANC \>1,000/$L and platelet count \>100,000/$L. Each cycle will consist of 4 weekly doses of carboplatin, three weekly doses of vincristine sulfate (given concomitantly with the first 3 weeks of carboplatin), followed by two weeks of rest for a total of 6 weeks. Maintenance will continue for a total of 8 cycles.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: