Brain Tumor, Central Nervous System Tumors
Conditions
Keywords
adult anaplastic oligodendroglioma, adult mixed glioma
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.
Interventions
DRUGtemozolomide
Schedule of Temozolomide administration: Temozolomide, 150 mg/m2/d x days 1-7 and 15-21, given every 28 days \[i.e., 7 days on/7 days off\]
Sponsors
National Cancer Institute (NCI)
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | Survival of Last Patient | Time in months to patient's disease progresses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity--Count of Related Advers Events | Post-Treatment | Count of Treatment Related Toxicities |
Countries
United States
Outcome results
None listed