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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00003494
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed recurrent or stage IV bronchoalveolar cell lung cancer unlikely to have a curative response to existing standard regimens
* Measurable disease by MRI or CT scan
* At least 2 cm in diameter
PATIENT CHARACTERISTICS:
Age:
* 18 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/SGPT no greater than 5 times upper limit of normal
* No hepatic failure
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 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 (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
* No serious active infections
* No other concurrent serious 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 allowed
Radiotherapy:
* At least 8 weeks since prior radiotherapy and recovered
Surgery:
* Recovered from prior surgery
Other:
* No prior antineoplaston therapy
* Prior cytodifferentiating agent allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00003494
Study Brief:
Protocol Section:
NCT00003494