Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma

Phase 2

Completed

• Conditions: Central Nervous System Tumors; Brain Tumor
• Interventions: Drug: temozolomide

• Registration Number: NCT00400816
• Lead Sponsor: The Cleveland Clinic

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.

Detailed Description

OBJECTIVES:

* Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide.

* Determine the response rate in these patients.

* Assess the quality of life of patients with AO or MOA treated with this regimen.

OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma).

Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for the first year after completion of treatment, every 4 months for the second year, every 6 months for the third and fourth years, and once a year thereafter.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-17
• Primary Completion: 2008-01-17
• Study Completion: 2016-01-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-09-14
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temozolomide	temozolomide	Temozolomide, 150 mg/m2/d x days 1-7 and 15-21

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	Survival of Last Patient	Time in months to patient's disease progresses

Secondary Outcome Measures

Name	Time	Method
Toxicity--Count of Related Advers Events	Post-Treatment	Count of Treatment Related Toxicities

Trial Locations

Locations (1)

Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States