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:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT00003532
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage III or IV epithelial or germ cell ovarian cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
* Measurable disease by CT scan or MRI
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/mL
* 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 other 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 for 4 weeks before, during, and for 4 weeks after study participation
* No active infection
* No concurrent serious systemic 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
Endocrine therapy:
* Concurrent corticosteroids allowed (e.g., dexamethasone or methylprednisone)
Radiotherapy:
* At least 8 weeks since prior radiotherapy and recovered
Surgery:
* Recovered from prior surgery
Other:
* Prior cytodifferentiating agents allowed
* No prior antineoplaston therapy
* No other concurrent antineoplastic agents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00003532
Study Brief:
Protocol Section:
NCT00003532