Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/20/2018 |
| Start Date: | August 2005 |
| End Date: | January 6, 2016 |
Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma
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.
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.
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.
- 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.
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
We found this trial at
1
site
Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
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