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 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT00004004
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven malignant glioma of one of the following types:
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Glioblastoma multiforme
* Progressive or recurrent disease after radiotherapy with or without chemotherapy
* Measurable disease by serial MR or CT
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Greater than 2 months
Hematopoietic:
* Absolute neutrophil count at least 1500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGPT/SGOT no greater than 4 times upper limit of normal
Renal:
* Creatinine no greater than 1.7 mg/dL
Other:
* No serious concurrent infection
* No other illness that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent filgrastim (G-CSF) during the first course
Chemotherapy:
* See Disease Characteristics
* No more than 1 prior chemotherapy regimen
* At least 3 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas)
* No more than 2 prior courses of carmustine or lomustine and no greater than 460 mg/m2 or 220 mg/m2, respectively
* No prior procarbazine
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* At least 3 months since prior radiotherapy
Surgery:
* Prior surgery allowed
Other:
* Recovered from toxicity of prior therapy
* At least 10 days since prior anticonvulsants for patients in Arm II
* No concurrent investigational agents
* No concurrent ethanol, ephedrine, isoproterenol, epinephrine, tricyclic antidepressants, paragyliline, narcotic analgesics, antihistamines, phenothiazines, hypotensives, or barbiturates
* At least 14 days since prior antidepressants (e.g., SSRI and/or MAO inhibitor)
* Must avoid foods high in tyramine (i.e., dark beer, wine, yogurt, cheese, bananas)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004004
Study Brief:
Protocol Section:
NCT00004004