Antineoplaston Therapy in Treating Patients With Stage IV Melanoma

Stage IV Melanoma 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 toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with Stage IV Melanoma,
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 Melanoma.

- 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 confirmed stage IV melanoma that is recurrent or progressing and
unlikely to respond to existing therapy

- Measurable disease by MRI or CT scan

- Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary,
inguinal, or femoral areas and at least 0.5 cm in other locations

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2,000/mm3

- Platelet count at least 50,000/mm3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

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

- No hepatic insufficiency

Renal:

- Creatinine no greater than 2.5 mg/dL

- No renal insufficiency

- No renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No chronic heart failure

- No uncontrolled hypertension

- No history of congestive heart failure

- No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

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

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study

- No serious medical or psychiatric disorders

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent immunomodulating agents

Chemotherapy:

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

- No concurrent antineoplastic agents

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors
who have received radiotherapy to some, but not all, tumors may be admitted earlier
than 8 weeks)

Surgery:

- Recovered from prior surgery

Other:

- Prior cytodifferentiating agent allowed

- No prior antineoplaston therapy