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

Phase 2

Completed

• Conditions: Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma
• Interventions: Drug: Temozolomide

• Registration Number: NCT01847235
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2013-04-29
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-06
• Primary Completion: 2015-09
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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Exclusion Criteria

• Prior course of temozolomide
• Combined glioblastoma
• Pregnant woman

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temozolomide	Temozolomide	Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	6 month	PFS will be examined with Kaplan-Meier method.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of