Clinical trial NCT01847235: Temozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Keywords: Temozolomide
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 6 month
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 1 years
measure: progression-free survival (PFS)
timeFrame: 1 year
measure: Number of Participants with Adverse Events
timeFrame: 1 years
Other outcomes:
measure: Predictive biomarker study
timeFrame: 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital, Seoul, South Korea
name: Tae Min Kim, MD, PhD
role: STUDY_CHAIR
References:
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