Status:
COMPLETED
Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Central Nervous System Tumors
Brain Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pha...
Detailed Description
OBJECTIVES: * Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide. * Determine the respons...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00400816
Start Date
August 1 2005
End Date
January 6 2016
Last Update
September 18 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065