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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT00003460
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed (except if medically contraindicated) incurable primitive neuroectodermal tumor
* Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior to study entry
* Must have received and failed prior standard therapy
* Tumor must be at least 5 mm
PATIENT CHARACTERISTICS:
Age:
* 6 months to 17 years
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* WBC at least 2000/mm\^3
* Platelet count greater than 50,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal
* No hepatic insufficiency
Renal:
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
* No uncontrolled hypertension
* No severe heart disease
* 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 and recovered
* No concurrent immunomodulating agents
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* 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 and recovered
Surgery:
* Not specified
Other:
* No prior antineoplaston treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT00003460
Study Brief:
Protocol Section:
NCT00003460