Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
This trial is active, not recruiting.
|Conditions||central nervous system tumors, brain tumor|
|Sponsor||The Cleveland Clinic|
|Collaborator||National Cancer Institute (NCI)|
|Start date||August 2005|
|End date||December 2015|
|Trial size||60 participants|
|Trial identifier||NCT00400816, CASE-CCF-4204, P30-CA43703|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: Survival of Last Patient
time frame: Post-Treatment
Male or female participants at least 18 years old.
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
|Official title||Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Pure and Mixed Anaplastic Oligodendroglioma|
|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.|
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