Stage IV Ovarian Cancer Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Carcinoma of the Ovary
Verified date | December 2017 |
Source | Burzynski Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Current therapies for Stage III or IV Ovarian Cancer provide very limited benefit to the
patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
beneficial in the treatment of Stage III or IV Ovarian Cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Stage III or IV Ovarian Cancer.
Status | Terminated |
Enrollment | 7 |
Est. completion date | October 18, 2002 |
Est. primary completion date | October 18, 2002 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Burzynski Clinic | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Burzynski Research Institute |
United States,
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