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 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT00003466
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including:
* Astrocytoma
* Oligodendroglioma
* Mixed glioma
* Optic pathway glioma\*
* Pontine glioma\* NOTE: \*Biopsy not required
* Patients with optic pathway glioma must also meet the following criteria:
* Progressive loss of vision as defined by doubling of octaves
* Visual acuity loss not explained by other causes
* Increase in proptosis of greater than 3 mm
* Increase in diameter of optic nerve of at least 2 mm on neuroimaging
* Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
* 4 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* More than 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT less than 2.5 times ULN
* Alkaline phosphatase less than 2 times ULN
Renal:
* Creatinine less than 1.5 times ULN
* BUN less than 1.5 times ULN
Other:
* Must be neurologically stable
* No systemic disease
* No acute infection requiring IV antibiotics
* No frequent vomiting
* No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction)
* No other prior or concurrent malignancies except:
* Surgically cured carcinoma in situ of the cervix
* Basal or squamous cell skin cancer
* HIV negative
* No AIDS-related illness
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent biologic therapy (growth factors or epoetin alfa)
Chemotherapy:
* At least 6 weeks since prior chemotherapy unless evidence of disease progression
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 6 weeks since prior radiotherapy unless evidence of disease progression
* No concurrent radiotherapy
Surgery:
* At least 3 weeks since prior surgery unless evidence of disease progression
* Recovered from all prior surgery
Other:
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT00003466
Study Brief:
Protocol Section:
NCT00003466