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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy and Safety of Temozolomide in Patients With Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: a Multicenter, Single-arm, Phase II Trial

Brief 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.

Detailed Summary:

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.


Sponsor: Seoul National University Hospital

Current Primary Outcome: Progression free survival (PFS) [ Time Frame: 6 month ]

PFS will be examined with Kaplan-Meier method.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Objective response rate (ORR) [ Time Frame: 1 year ]
    ORR will be evaluated through the frequency analysis with 95% confidence interval.
  • Overall survival (OS) [ Time Frame: 1 years ]
    OS will be examined with Kaplan-Meier method.
  • progression-free survival (PFS) [ Time Frame: 1 year ]
    PFS will be examined with Kaplan-Meier method.
  • Number of Participants with Adverse Events [ Time Frame: 1 years ]
    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.


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: April 29, 2013
Date Started: May 2013
Date Completion:
Last Updated: April 22, 2016
Last Verified: April 2016