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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT00079092
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant glioma
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Glioblastoma multiforme
* Anaplastic mixed oligoastrocytoma
* Progressive or recurrent disease\* after radiotherapy with or without chemotherapy NOTE: \*Patients with prior low-grade glioma who progressed after therapy and are found to have high-grade glioma are eligible
* Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* More than 2 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 mg/dL
* Transaminases ≤ 4 times upper limit of normal
Renal
* Creatinine ≤ 1.7 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 1 highly active method and 1 additional effective method of contraception for 1 month before, during, and for 4 weeks after study treatment
* No concurrent serious infection
* No other concurrent medical illness that would preclude study treatment
* No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior thalidomide
* No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No prior procarbazine
* No more than 2 prior chemotherapy regimens for malignant glioma
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 3 months since prior radiotherapy
Other
* Recovered from prior therapy
* More than 7 days since prior antidepressants (selective serotonin reuptake inhibitors and/or monamine oxidase inhibitors)
* No concurrent antidepressants
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00079092
Study Brief:
Protocol Section:
NCT00079092