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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT00003456
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed Glioblastoma Multiforme
* Subtotal resection or biopsy only of tumor
* Measurable tumor by MRI scan performed within two weeks prior to study entry
* Tumor must be at least 5 mm
* No brain stem tumor
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* More than 4 months
Hematopoietic:
* WBC at least 1,500/mm\^3
* Platelet count at least 50,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* No hepatic failure
* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that would contraindicate high dosages of sodium
Cardiovascular:
* No uncontrolled hypertension
Other:
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy
* No concurrent immunomodulatory agents
Chemotherapy:
* No prior chemotherapy
* No concurrent antineoplastic agents
Endocrine therapy:
* Concurrent corticosteroids for cerebral edema allowed
Radiotherapy:
* No prior radiotherapy
Surgery:
* See Disease Characteristics
* Recovered from any prior surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00003456
Study Brief:
Protocol Section:
NCT00003456