Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin
Condition: Unknown Primary Carcinoma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Patients with Cancer of Unknown Primary Origin 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: 8.0
Sex: All
Minimum age: 6 Months
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      Current therapies for Cancer of Unknown Primary Origin provide very limited benefit to the
      patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
      beneficial in the treatment of Cancer of Unknown Primary Origin.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on patients with Cancer of Unknown Primary Origin.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of unknown primary that is unlikely to respond
             to existing therapy, including surgery, radiotherapy, and chemotherapy

               -  Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan

        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:

          -  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 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, such as chronic obstructive pulmonary disease

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 4 weeks after study
             participation

          -  No active infection

          -  No nonmalignant systemic disease

          -  Not a high medical or psychiatric risk

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since prior immunotherapy

          -  No concurrent immunomodulating agents

        Chemotherapy:

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

        Endocrine therapy:

          -  Concurrent corticosteroids allowed

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy

        Surgery:

          -  Recovered from prior surgery

        Other:

          -  Prior cytodifferentiating agents allowed

          -  No prior antineoplastons

          -  No other concurrent antineoplastic agents