INTRAVENOUS CARBOPLATIN FOR RECURRENT GLIOMAS - A DOSE-ESCALATING PHASE-II TRIAL

In a Phase II trial, 63 evaluable patients with recurrent glioma recei ved i.v. infusions of carboplatin every 3 weeks beginning at a dose of 400 mg/m(2). The dose was increased by 50 mg/m(2) at each subsequent infusion until the maximum tolerated dose was reached, as defined by a platelet count < 25,000/mm(3) or an absolute neutrophil count (ANC) < 500/mm(3). Treatment was then resumed at the previous dose level and continued until tumor progression occurred. There were 43 men and 20 w omen studied (mean age, 41 years; range, 6 months to 70.6 years). The combined response and stabilization rate was 29% for 31 patients with glioblastoma and 71.9% for 32 patients with other tumors; median time to tumor progression was 8.2 and 20.3 weeks and median survival was 25 .9 and 58.3 weeks, respectively. Twenty patients had level 4 platelet toxicity and nine had level 4 ANC toxicity. Most tumors progressed bef ore the maximum tolerated dose was reached. These results were not bet ter than those from a previous trial of carboplatin at an initial dose of 350 mg/m(2), which was escalated by 25 mg/m(2) after every two inf usions. Therefore, an optimal dosing schedule was not achieved in this trial.