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


Phase 2
20 Years
N/A
Not Enrolling
Both
Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Description:

PFS will be examined with Kaplan-Meier method.

Outcome Time Frame:

6 month

Safety Issue:

No

Principal Investigator

Se-Hoon LEE, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Seoul National University Hospital, Seoul, South Korea

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

OD_OA

NCT ID:

NCT01847235

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Anaplastic Oligodendroglioma
  • Anaplastic Oligoastrocytoma
  • Temozolomide
  • Oligodendroglioma

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