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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT00003508
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists
* Evidence of disease by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
* 1 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* 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 and SGPT no greater than 5 times upper limit of normal
* Hepatic function adequate
Renal:
* Creatinine no greater than 2.5 mg/dL
* No renal insufficiency
* No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
* No uncontrolled hypertension
* No history of congestive heart failure
* No cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
* No serious lung disease (e.g., chronic obstructive pulmonary disease)
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* Not at high medical or psychiatric risk
* No nonmalignant systemic disease
* No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulatory agents
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
* Concurrent corticosteroids allowed
Radiotherapy:
* At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered
Surgery:
* Recovered from prior surgery
Other:
* Prior cytodifferentiating agents allowed
* No prior antineoplastons
* No other concurrent antineoplastic agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
120 Years
Study:
NCT00003508
Study Brief:
Protocol Section:
NCT00003508