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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT00003505
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage I-IV primary central nervous system lymphoma for which no curative therapy exists
* Measurable tumor by MRI or CT scan
* Tumor must be greater than 2 cm in largest diameter
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* WBC greater than 2,000/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 cardiac insufficiency
* No hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for at least 4 weeks after study participation
* No serious infection requiring antibiotics, antifungals, or antivirals
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulatory agents (e.g., interferon or interleukin-2)
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No concurrent antineoplastic agent
Endocrine therapy:
* Concurrent corticosteroids allowed
* Must be on stable dose for at least 4 weeks prior to study entry
Radiotherapy:
* At least 8 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* No prior antineoplastons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003505
Study Brief:
Protocol Section:
NCT00003505