Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT00004259
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the following:
* Anaplastic astrocytoma
* Mixed oligodendroglial/astrocytic tumors
* Oligodendroglial component must be no greater than 25%
* No vascular proliferation and necrosis
* Increased cellularity, pleomorphism, and nuclear atypia allowed
* No tumor predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
* Patients with prior biopsy proven low grade astrocytoma who now have anaplastic astrocytoma and have had no prior radiotherapy or chemotherapy also eligible
* Study therapy must begin within 6 weeks of diagnosis
* No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges
* Pathologic evidence of local meningeal infiltration by underlying tumor allowed
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 1 year
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 150,000/mm\^3
Hepatic:
* Bilirubin less than 2 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) less than 2 times ULN
* Alkaline phosphatase less than 2 times ULN
Renal:
* Blood urea nitrogen no greater than 25 mg/dL
* Creatinine less than 1.5 times normal
Pulmonary:
* No pre-existing lung disease that, in the investigator's opinion, would preclude administration of carmustine or lomustine or completion of therapy
Other:
* No other major medical illness or psychiatric impairment that would preclude study compliance
* No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
* No known hypersensitivity to 1 of the components of carmustine, lomustine, temozolomide, dacarbazine, or any other nitrosourea
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy
Chemotherapy:
* See Disease Characteristics
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy to brain or head and neck
Surgery:
* Not specified
Other:
* No other concurrent anticancer treatment for anaplastic astrocytoma until a recurrence is detected
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00004259
Study Brief:
Protocol Section:
NCT00004259