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Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma


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

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Trial Information

Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma


Temozolomide has demonstrated clinical antitumor efficacy against malignant gliomas at both
relapse and initial diagnosis. This drug appears to have less adverse effects compared to
other drugs used against brain tumors. Therefore, temozolomide is often better tolerated in
brain tumor patients compared to other brain tumor drugs. The current study builds on
previous research to test the efficacy of chemotherapy alone in patients with anaplastic
oligodendroglioma and mixed oligoastrocytoma.

Purpose:

This study will evaluate response rate, or how the disease size changes in patients, and
survival without disease growth, in patients with anaplastic oligodendroglioma and mixed
oligoastrocytoma treated with temozolomide. Quality of life will also be assessed in this
patient population treated with the study regimen.

Treatment:

Study participants will be treated with the drug temozolomide. This drug will be
administered in oral pills. Temozolomide will be taken for seven consecutive days followed
by seven days without the drug. This treatment schedule of seven days on temozolomide
followed by seven days off will continue throughout the study. Several tests and exams will
be given to closely monitor patients. MRI scans will be performed every 8 weeks to measure
disease response. Temozolomide as a study drug will be given to study participants for a
total of 8 week four cycles. However, treatments will be discontinued due to disease growth
or unacceptable adverse events.


Inclusion Criteria:



- anaplastic oligodendroglioma or mixed oligoastrocytoma

- age > 18

- Karnofsky status > 70%

- adequate bone marrow, liver and renal function

Exclusion Criteria:

- prior chemotherapy or cranial irradiation

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine progression free survival and response rate in patients with newly diagnosed AO and MOA of Temozolomide given every other week.

Outcome Time Frame:

2007-20011

Safety Issue:

Yes

Principal Investigator

Herbert Newton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-0222

NCT ID:

NCT00362570

Start Date:

May 2005

Completion Date:

March 2011

Related Keywords:

  • Oligoastrocytoma, Mixed
  • Anaplastic Oligodendroglioma
  • Newly diagnosed
  • Oligodendroglioma
  • Astrocytoma

Name

Location

Ohio State UniversityColumbus, Ohio  43210