Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas

PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

May 31, 2018

Study Completion Date

June 30, 2018

Conditions
High-grade Gliomas
Interventions
DRUG

CDDP

DRUG

Temozolomide

If hematologic and nonhematologic toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE; version 4.0) from the previous cycle had been grade 0 or 1, then TMZ dose escalation to was allowed to the maximum of 150 mg/m2. If grade 4 hematologic toxicity or grade 3 nonhematologic toxicity had occurred, then TMZ dose was reduced in 25 mg/m2 steps. If grade 4 nonhematologic toxicity occurred, patient treatment was halted. If grade 4 hematologic toxicity or grade 3 nonhematologic toxicity continued when TMZ dose was in the minimum of 75 mg/m2, patient treatment was halted.

Trial Locations (1)

200040

Huashan Hospital, Shanghai

All Listed Sponsors
lead

Huashan Hospital

OTHER

NCT02263105 - Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas | Biotech Hunter | Biotech Hunter