Combination Chemotherapy in Treating Children With Progressive Brain Tumors

Summary

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.

Timeline

Start

1997-04

Primary completion

2006-02

Completion

2012-04

Outcome

Missed primary endpoint

paper The 5-year EFS rates were 39% ± 4% for CV and 52% ± 5% for TPCV (stratified log-rank test P = .10; PMID 22665535 ↗

paper The difference in EFS between the regimens did not reach significance on the basis of the stratified log-rank test. PMID 22665535 ↗

Publications

• Results Ater JL, Zhou T, Holmes E, Mazewski CM, Booth TN, Freyer DR, Lazarus KH, Packer RJ, Prados M, Sposto R, Vezina G, Wisoff JH, Pollack IF. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2641-7. doi: 10.1200/JCO.2011.36.6054. Epub 2012 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	—	Intravenous
Subject	Lomustine	Small molecule	—	Intravenous
Subject	Thioguanine	Small molecule	—	Oral
Subject	Vincristine	Small molecule	—	Oral
Subject	procarbazine	Small molecule	—	Oral

Indications