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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00003457
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed brain tumor (except brain stem locations) that is unlikely to respond to existing therapy and for which no curative therapy exists
* Evidence of persistent or recurrent brain tumor by MRI scan performed within two weeks prior to study entry
* Tumor must be at least 5 mm
* Ineligible for other Burzynski Research Institute, Inc. brain tumor protocols
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* Hemoglobin at least 9 g/dL
* WBC at least 2,000/mm\^3
* Platelet count at least 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 history of 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 concurrent 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 a stable dose for at least 1 week prior to study entry)
Radiotherapy:
* At least 8 weeks since prior radiotherapy
Surgery:
* Must recover from prior surgery
Other:
* Prior cytodifferentiating agent allowed
* No prior antineoplaston therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00003457
Study Brief:
Protocol Section:
NCT00003457