drugset / Trial / NCT00238173

Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors

NCT00238173

RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, etoposide phosphate, 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. Mannitol may help chemotherapy work better by making it easier for these drugs to get to the tumor. Chemoprotective drugs, such as acetylcysteine and sodium thiosulfate, may protect normal cells from the side effects of chemotherapy. Giving acetylcysteine together with mannitol, combination chemotherapy, and sodium thiosulfate may be an effective treatment for malignant brain tumors. PURPOSE: This phase I trial is studying the side effects and best dose of acetylcysteine when given together with mannitol, combination chemotherapy, and sodium thiosulfate in treating children with malignant brain tumors.

Timeline

Start
2004-12
Primary completion
2006-02-17
Completion
2006-02-17

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule Intravenous
Background Carboplatin Small molecule 200 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 330 mg/m2 Intravenous
Background Etoposide Small molecule 200 mg/m2 Intravenous
Background Mannitol Diagnostic / imaging agent 25 % Intravenous
Background Sodium Thiosulfate Diagnostic / imaging agent 16 unknown Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous