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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT00036660
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant glioma
* Anaplastic astrocytoma (AA) OR
* Glioblastoma multiforme (GBM)
* Recurrent or progressive disease by contrast-enhanced CT scan or MRI after primary surgery and radiotherapy
* At least 1 bidimensionally measurable lesion
* At least 1 cm by 1 cm on contrast-enhanced CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm3
* Platelet count at least 120,000/mm3
Hepatic:
* Bilirubin normal
* AST and ALT no greater than 2.5 times upper limit of normal
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Pulmonary:
* DLCO at least 70% of predicted
* FVC at least 70% of predicted
Other:
* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
* No ongoing or active uncontrolled infection
* No other serious illness or medical condition that would preclude study
* No history of significant neurologic or psychiatric disorder that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 6 weeks since prior immunotherapy
* No concurrent immunotherapy
Chemotherapy:
* At least 6 weeks since prior chemotherapy
* No more than 1 prior adjuvant chemotherapy regimen for AA
* No prior chemotherapy for recurrent disease
* No other concurrent chemotherapy
Endocrine therapy:
* Patients must be on a stable dose of steroids for at least 2 weeks prior to study
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No prior radiotherapy for recurrent disease
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* Prior surgery for recurrent disease (e.g., stereotactic biopsy or partial resection) allowed
* At least 4 weeks since prior surgery (except for biopsy)
Other:
* At least 6 weeks since prior investigational agents
* No other concurrent investigational agents
* No other concurrent anticancer treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00036660
Study Brief:
Protocol Section:
NCT00036660