Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
Condition: Stage IV Melanoma
MeSH terms: Melanoma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Patients with Stage IV Melanoma will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Stage IV melanoma of the skin

Summary:

      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.
    

Eligibility criteria:

        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