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.
Stage III or IV Ovarian Cancer patients receive gradually escalating doses of intravenous
Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
Treatment continues up to 12 months in the absence of disease progression or unacceptable
- To determine the efficacy of Antineoplaston therapy in patients with Stage III or IV
Ovarian Cancer, as measured by an objective response to therapy (complete response,
partial response or stable disease).
- To determine the safety and tolerance of Antineoplaston therapy in patients with Stage
III or IV Ovarian Cancer.
- To determine objective response, tumor size is measured utilizing MRI scans, which are
performed every 8 weeks for the first two years, every 3 months for the third and fourth
years, every 6 months for the 5th and sixth years, and annually thereafter.
- 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
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
- Creatinine no greater than 2.5 mg/mL
- No renal insufficiency
- No history of renal conditions that contraindicate high dosages of sodium
- No uncontrolled hypertension
- No history of congestive heart failure
- No other cardiovascular conditions that contraindicate high dosages of sodium
- No serious lung disease (e.g., chronic obstructive pulmonary disease)
- 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:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulating agents
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- Concurrent corticosteroids allowed (e.g., dexamethasone or methylprednisone)
- At least 8 weeks since prior radiotherapy and recovered
- Recovered from prior surgery
- Prior cytodifferentiating agents allowed
- No prior antineoplaston therapy
- No other concurrent antineoplastic agents