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 IV cancer of the cervix and/or vulva.
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with incurable carcinoma of the uterine cervix and/or vulva.
- Describe response, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous
injection 6 times daily until the maximum tolerated dose 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 reaching 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 proven incurable stage IV carcinoma of the uterine cervix and/or vulva
that is unlikely to respond to existing therapy
- Measurable disease by MRI or CT scan
- Tumor must be at least 2 cm
- 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
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
- No renal insufficiency
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
- 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
- No serious lung disease, such as chronic obstructive pulmonary disease
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Not a high medical or psychiatric risk
- No concurrent nonmalignant systemic disease
- No active infection
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulatory agents
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- At least 1 month since prior tamoxifen if no progression
- May enter study immediately if evidence of progression
- Concurrent corticosteroids allowed
- At least 8 weeks since prior radiotherapy and recovered
- Recovered from prior surgery
- Prior cytodifferentiating agents allowed
- No prior antineoplastons
- No other concurrent antineoplastic agents