This trial is active, not recruiting.

Conditions central nervous system tumors, brain tumor
Treatment temozolomide
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Progression-Free Survival
time frame: Survival of Last Patient

Secondary Outcomes

time frame: Post-Treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.