Status:
COMPLETED
Temozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial
Lead Sponsor:
Seoul National University Hospital
Conditions:
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 Description
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 conse...
Eligibility Criteria
Inclusion
- 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
- Prior course of temozolomide
- Combined glioblastoma
- Pregnant woman
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01847235
Start Date
May 1 2013
End Date
March 1 2016
Last Update
April 26 2016
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744