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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00006093
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy and/or chemotherapy
* Eligible subtypes:
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Glioblastoma multiforme
* Prior low-grade glioma that has progressed to a high-grade glioma (by biopsy) after radiotherapy and/or chemotherapy allowed
* Measurable disease by volumetric and magnetic resonance perfusion scan
* Prior biopsy or resection of recurrent brain tumor allowed
PATIENT CHARACTERISTICS:
Age:
* 18 and over
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
Hepatic:
* Bilirubin normal
* Transaminases no greater than 2.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No advanced coronary artery disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious concurrent infection or medical illness that would preclude study
* No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
* No history of wound healing disorders
* No peptic ulcer disease within the past year
* Mini mental score of at least 15
* Willing and able to undergo MRI
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent filgrastim (G-CSF)
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No more than 2 prior chemotherapy regimens
Endocrine therapy:
* Prior corticosteroids allowed if on stable dose for at least 5 days prior to study
* Concurrent corticosteroids (e.g., dexamethasone) allowed as clinically needed
Radiotherapy:
* See Disease Characteristics
* At least 3 months since prior radiotherapy and recovered
Surgery:
* See Disease Characteristics
* At least 1 week since prior surgery and recovered
* No concurrent elective surgery or dental extractions
Other:
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006093
Study Brief:
Protocol Section:
NCT00006093