RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the
laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating
patients who have stage III or stage IV ovarian cancer
- Study the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with incurable stage III or IV ovarian cancer.
- Describe response to, tolerance to, and side effects of this regimen in this patient
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1
by intravenous injection 6 times daily until the maximum tolerated dose level is reached.
Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after achieving CR.
Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- 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