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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00036894
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* One of the following:
* Histologically confirmed high-grade glioma
* Glioblastoma multiforme
* Gliosarcoma
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Anaplastic mixed oligoastrocytoma
* Malignant glioma/astrocytoma, not otherwise specified
* Meningioma
* Hemangioblastoma
* Ependymoma
* Primitive neuroectodermal tumors
* Hemangiopericytoma
* Progressive glioma
* Clinically and radiographically diagnosed brain stem glioma
* Progressive or recurrent disease as determined by CT scan or MRI
* Biopsy allowed for prior recent (i.e., within the past 12 weeks) resection of recurrent or progressive tumor
* Must have failed prior radiotherapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* More than 8 weeks
Hematopoietic:
* WBC at least 2,300/mm\^3
* Platelet count at least 90,000/mm\^3
* Hemoglobin at least 8 g/dL (transfusions allowed)
Hepatic:
* Bilirubin less than 3 times upper limit of normal (ULN)
* SGOT less than 3 times ULN
* No significant active hepatic disease
Renal:
* Creatinine less than 2.0 mg/dL OR
* Creatinine clearance at least 60 mL/min
* No significant active renal disease
Cardiovascular:
* No significant active cardiac disease
Other:
* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No significant active psychiatric disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 2 weeks since prior interferon
* No concurrent immunotherapy
Chemotherapy:
* At least 6 weeks since prior nitrosoureas
* At least 4 weeks since prior temozolomide or carboplatin
* At least 3 weeks since prior procarbazine
* At least 2 weeks since prior vincristine
* At least 4 weeks since other prior cytotoxic chemotherapy
* No concurrent chemotherapy
Endocrine therapy:
* At least 2 weeks since prior tamoxifen
* Concurrent steroids allowed for control of the signs and symptoms of increased intracranial pressure if on a stable dose for at least the past 5 days
Radiotherapy:
* See Disease Characteristics
* At least 2 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* At least 2 weeks since prior tumor resection
Other:
* At least 2 weeks since other prior noncytotoxic agents
* Concurrent enzyme-inducing antiepileptic drugs allowed
* No concurrent rifampin
* No concurrent grapefruit juice
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00036894
Study Brief:
Protocol Section:
NCT00036894