Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva

Stage IV Cancer of the Cervix and/or Vulva patients receive gradually escalating doses of
intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose
is reached. Treatment continues up to12 months in the absence of disease progression or
unacceptable toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with Stage IV Cancer of
the Cervix and/or Vulva, 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
IV Cancer of the Cervix and/or Vulva.

- 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.

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