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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT00003459
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed (except if medically contraindicated) brain stem glioma that is unlikely to respond to existing therapy and for which no curative therapy exists.
* Tumor must be at least 5 mm in maximum diameter
PATIENT CHARACTERISTICS:
Age:
* 6 months or greater
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* WBC at least 2,000/mm\^3
* Platelet count greater than 50,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT no greater than 5 times upper limit of normal
* No hepatic failure
Renal:
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
* No severe heart disease
* No uncontrolled hypertension
* No history of congestive heart failure
* No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
* No severe lung disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No serious active infections or fever
* No other serious concomitant disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy
* No concurrent immunomodulating agents
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No concurrent antineoplastic agents
Endocrine therapy:
* Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week before study entry)
Radiotherapy:
* At least 8 weeks since prior radiotherapy
Surgery:
* Not specified
Other:
* No prior Antineoplaston therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
99 Years
Study:
NCT00003459
Study Brief:
Protocol Section:
NCT00003459