Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Uterine Cervix and/or Vulva

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

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:

- No hepatic insufficiency

- Bilirubin no greater than 2.5 mg/dL

- SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

- No renal insufficiency

- Creatinine no greater than 2.5 mg/dL

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- 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
sodium

Pulmonary:

- No serious lung disease, such as chronic obstructive pulmonary disease

Other:

- 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:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent immunomodulatory agents

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

- At least 1 month since prior tamoxifen if no progression

- May enter study immediately if evidence of progression

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Recovered from prior surgery

Other:

- Prior cytodifferentiating agents allowed

- No prior antineoplastons

- No other concurrent antineoplastic agents