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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT00075894
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant glioma of 1 of the following types:
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Glioblastoma multiforme
* Progressive or recurrent disease after prior radiotherapy with or without chemotherapy
* Low-grade glioma that progressed after prior radiotherapy with or without chemotherapy and is found to be high-grade glioma after biopsy allowed
* No more than 2 prior treatment regimens
* Measurable disease by CT scan or MRI
* Documented absence of methylthioadenosine phosphorylase (MTAP) on fixed tumor specimens
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
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 ≤ 1.5 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception before, during, and for 4 weeks after study participation
* Mini mental state exam score of ≥ 15
* No psychological or sociological condition, addictive disorder, or family problem that would preclude study compliance
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
* No concurrent serious infection or medical illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
Chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy
* Must be maintained on a stable or lower corticosteroid regimen from the time of the baseline scan until the start of study treatment
* No concurrent steroids as antiemetics
Radiotherapy
* See Disease Characteristics
* At least 3 months since prior radiotherapy
Surgery
* Not specified
Other
* Recovered from prior therapy
* More than 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00075894
Study Brief:
Protocol Section:
NCT00075894