Antineoplaston Therapy in Treating Patients With Stage IV Melanoma

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Malignant Melanoma

Current therapies for Stage IV Melanoma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV Melanoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on 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