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

April 22, 2016 updated by: Tae Min Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Temozolomide
Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days
Drug: Temozolomide
Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle).
Other Names:
  • Temodal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 6 month
PFS will be examined with Kaplan-Meier method.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 1 year
ORR will be evaluated through the frequency analysis with 95% confidence interval.
1 year
Overall survival (OS)
Time Frame: 1 years
OS will be examined with Kaplan-Meier method.
1 years
progression-free survival (PFS)
Time Frame: 1 year
PFS will be examined with Kaplan-Meier method.
1 year
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.
1 years

Other Outcome Measures

Outcome Measure
Time Frame
Predictive biomarker study
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Tae Min Kim, MD, PhD, Seoul National University Hospital, Seoul, South Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (ESTIMATE)

May 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OD_OA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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