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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT00003534
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed incurable stage IV adenocarcinoma of the prostate that failed to respond to treatment with antineoplaston A10 and AS2-1 capsules and for which no curative therapy exists
* Evidence of tumor by MRI or CT scan
* No prostate-specific antigen (PSA) response to antiandrogen withdrawal
* If PSA changes used to indicate progressive disease, then PSA must increase more than 50% on two determinations at least 2 weeks apart
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 2000/mm\^3
* Platelet count at least 50,000/mm\^3
Hepatic:
* No hepatic insufficiency
* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
* No known chronic heart failure
* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
* No serious lung disease, such as severe chronic obstructive pulmonary disease
Other:
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* Not a high medical or psychiatric risk
* No concurrent nonmalignant systemic disease that would preclude therapy
* No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
Chemotherapy:
* At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
* See Disease Characteristics
* At least 4 weeks since prior hormonal therapy and recovered
* Concurrent corticosteroids allowed if dose is stable or decreasing
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
Surgery:
* Recovered from prior surgery
Other:
* Prior cytodifferentiating agents allowed
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00003534
Study Brief:
Protocol Section:
NCT00003534