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.
Patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma will be enrolled. Enrolled patients will begin on temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle). Patients who were previously treated with any chemotherapy initially received temozolomide 150 mg/m2/d for 5 days (750 mg/m2 per cycle).Patients will be receving a total 6 cycles of chemotheray (4weeks/cycle \* 6cycles = 24weeks). If the patients shows responses to Temozolomide, treatment can be continued by the investigator's discretion. During the administration of Temozolomide, vital signs, physical examination, ECOG performance status, height, weight, hematology and chemistry test, adverse events and concomitant drugs will be evaluated every four weeks. Brain MRI for tumor assessment will be performed once every 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle).
Seoul National University Hospital
Seoul, South Korea
Progression free survival (PFS)
PFS will be examined with Kaplan-Meier method.
Time frame: 6 month
Objective response rate (ORR)
ORR will be evaluated through the frequency analysis with 95% confidence interval.
Time frame: 1 year
Overall survival (OS)
OS will be examined with Kaplan-Meier method.
Time frame: 1 years
progression-free survival (PFS)
PFS will be examined with Kaplan-Meier method.
Time frame: 1 year
Number of Participants with Adverse Events
Regarding safety endpoints, all adverse events will be individually graded based on the CTCAE version 4.03. The number of participants with adverse events will be summarized using descriptive statistics.
Time frame: 1 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.