Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer
Condition: Stage IV Adrenocortical Carcinoma
MeSH terms: Carcinoma; Adrenocortical Carcinoma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Patients with Stage IV Adrenal Gland Cancer 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: 6.0
Sex: All
Minimum age: 6 Months
Maximum age: 99 Years
Healthy volunteers: No
Keywords: recurrent adrenocortical carcinoma

Summary:

      Current therapies for Stage IV adrenal gland cancer 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 adrenal gland cancer

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on patients with Stage IV adrenal gland cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage IV adrenal gland carcinoma that is unlikely to respond
             to existing therapy and for which no curative therapy exists

          -  Measurable disease by MRI or CT scan

          -  Tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in
             the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the
             largest diameter for other localizations

        PATIENT CHARACTERISTICS:

        Age:

          -  6 months 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:

          -  Bilirubin no greater than 2.5 mg/dL

          -  SGOT/SGPT no greater than 5 times upper limit of normal

          -  No hepatic failure

        Renal:

          -  Creatinine no greater than 2.5 mg/dL

          -  No history of renal conditions that contraindicate high dosages of sodium

        Cardiovascular:

          -  No severe heart disease

          -  No uncontrolled hypertension

          -  No history of congestive heart failure

          -  No history of other cardiovascular conditions that contraindicate high dosages of
             sodium

        Pulmonary:

          -  No severe lung disease

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 4 weeks after study
             participation

          -  No serious active infections or fever

          -  No other concurrent serious disease

        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

        Surgery:

          -  Recovered from any prior operative procedure

        Other:

          -  No prior antineoplaston therapy

          -  Prior cytodifferentiating agent allowed