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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT00006656
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven supratentorial malignant glioblastoma multiforme
* Clear evidence of disease progression by MRI
* Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated)
* Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm
* No brainstem (pons or medulla) or midbrain (mesencephalon) involvement
* No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve
* No tumor extension into the ventricular system
* Tumor volume no greater than 33.4 cm3
* At least one prior radiotherapy
PATIENT CHARACTERISTICS:
Age:
* 18 to 75
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No evidence of bleeding diathesis
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* SGOT/SGPT no greater than 2.5 times normal
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 40 mL/min
* BUN no greater than 30 mg/dL
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active uncontrolled infection
* Afebrile unless fever due to presence of tumor
* No other concurrent serious medical or psychiatric illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No prior intracranial brachytherapy
Surgery:
* Recovered from any prior surgery
Other:
* No prior anticoagulants
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00006656
Study Brief:
Protocol Section:
NCT00006656