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 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT00004868
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven supratentorial malignant primary glioma, including:
* Glioblastoma multiforme
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Anaplastic mixed oligoastrocytoma
* Malignant astrocytoma not otherwise specified
* Benign or malignant meningiomas, including brain and spinal meningiomas
* Patients with meningiomas are excluded from phase II portion of study
* Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or MRI
* Must have failed prior radiotherapy
* Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days
* Must be on stable (unchanged) dose of steroids for at least 5 days before scans
* Phase II:
* Must have completed radiotherapy at least 2 months prior to enrollment
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 100,000/mm\^3
* Hemoglobin at least 8 g/dL (transfusion allowed)
Hepatic:
* SGOT less than 2.5 times upper limit of normal
* Bilirubin normal
* No significant active hepatic disease
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
* No significant active renal disease
Cardiovascular:
* No uncompensated coronary artery disease on ECG or physical examination
* No history of myocardial infarction or severe/unstable angina within the past 6 months
* No deep venous or arterial thrombosis within the past 3 months
Pulmonary:
* No pulmonary embolism within the past 3 months
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 2 months after study
* No other serious concurrent illness
* No significant active psychiatric disease
* No diabetes mellitus with severe peripheral vascular disease
* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No serious active infection
* No other concurrent disease that would obscure toxic effects or dangerously alter drug metabolism
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered
* No concurrent immunotherapy
Chemotherapy:
* Phase I:
* No more than 2 prior chemotherapy regimens for recurrent disease
* Phase II:
* No more than 1 prior chemotherapy regimen for recurrent disease
* At least 2 weeks since prior vincristine
* At least 6 weeks since prior nitrosoureas
* At least 3 weeks since prior procarbazine
* Recovered from prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy:
* See Disease Characteristics
* At least 3 weeks since prior endocrine therapy (e.g., tamoxifen) and recovered
Radiotherapy:
* See Disease Characteristics
* No concurrent radiotherapy
Surgery:
* Recovered from prior surgery
* Recent prior resection of recurrent or progressive tumor allowed
Other:
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00004868
Study Brief:
Protocol Section:
NCT00004868