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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00400816

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

125.2

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central Nervous System Tumors Brain Tumor	Drug: temozolomide	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Jan 17, 2008

Actual Study Completion Date :

Jan 6, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Temozolomide Temozolomide, 150 mg/m2/d x days 1-7 and 15-21	Drug: temozolomide Schedule of Temozolomide administration: Temozolomide, 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off] Other Names: Temodar

Arm

Intervention/Treatment

Experimental: Temozolomide

Temozolomide, 150 mg/m2/d x days 1-7 and 15-21

Drug: temozolomide

Schedule of Temozolomide administration: Temozolomide, 150 mg/m2/d x days 1-7 and 15-21, given every 28 days [i.e., 7 days on/7 days off]

Other Names:

Temodar

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity--Count of Related Advers Events [Post-Treatment]
Count of Treatment Related Toxicities

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma meeting 1 of the following criteria:
Bidimensionally measurable disease
Evaluable disease
Nonevaluable disease as demonstrated by gross total surgical resection
No immediate need for cranial irradiation

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%
Life expectancy ≥ 12 weeks
Absolute granulocyte count ≥ 1,500/mm³
Hemoglobin ≥ 10.0 g/dL
Platelet count ≥ 100,000/mm³
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Bilirubin ≤ 2.0 times ULN
AST ≤ 3.0 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No infection requiring systemic antibiotics within the past 14 days
No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer
No unrelated medical problems that would preclude study compliance

PRIOR CONCURRENT THERAPY:

No prior chemotherapy for this malignancy
No prior radiotherapy to the brain
No surgery requiring general anesthesia > 2 hours in duration within the past 10 days
No prior temozolomide
Concurrent steroids allowed provided dose is stable or decreasing for at least 1 week prior to study entry