Temozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and safety of temozolomide in patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Histologically proven anaplastic oligodendroglioma or oligoastrocytoma

• Progressed or relapsed after surgery or radiation therapy

• Female or male aged 20 years or over

• At least 1 measurable mass lesion

• ECOG performance status 0-3

• Adequate organ function

• absolute neutrophil count > 1,500/μL

• platelet count > 75,000/μL

• hemoglobin greater than 9 g/dL or 900g/L

• serum creatinine less than 1.5 times the upper limit of laboratory normal

• total serum bilirubin less than 1.5 times the upper limit of laboratory normal

• AST or ALT less than three times the upper limit of laboratory normal

Exclusion Criteria:

• Prior course of temozolomide

• Combined glioblastoma

• Pregnant woman