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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT00003461
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed newly diagnosed or recurrent supratentorial primary or metastatic malignant brain tumor
* Measurable disease by MRI or CT scan
* Candidate for surgical resection
* Extension of tumor no more than 1.0 cm beyond the margin of the surgical cavity
* Demonstrated reactivity of tumor cells with tenascin by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody
* No infratentorial tumors, diffusely infiltrating tumors, tumors with subependymal spread, or multifocal tumors
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 50-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 mg/dL
* Alkaline phosphatase less than 1.5 times normal
* SGOT less than 1.5 times normal
Renal:
* Creatinine less than 1.2 mg/dL
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 6 weeks since prior chemotherapy, unless unequivocal evidence of progression
Endocrine therapy:
* Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week
Radiotherapy:
* At least 3 months since prior radiotherapy to site of measurable disease in the CNS
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003461
Study Brief:
Protocol Section:
NCT00003461