Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
Condition: Malignant Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Patients with advanced mesothelioma 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.hourly interEach 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: 1 Year
Maximum age: 120 Years
Healthy volunteers: No
Keywords: advanced malignant mesothelioma; recurrent malignant mesothelioma

Summary:

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

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage IV mesothelioma that is unlikely to respond to existing
             therapy and for which no curative therapy exists

               -  Evidence of disease by CT scan or MRI

        PATIENT CHARACTERISTICS:

        Age:

          -  1 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 and SGPT no greater than 5 times upper limit of normal

          -  Hepatic function adequate

        Renal:

          -  Creatinine no greater than 2.5 mg/dL

          -  No renal insufficiency

          -  No history of renal conditions that contraindicate high dosages of sodium

        Cardiovascular:

          -  No uncontrolled hypertension

          -  No history of congestive heart failure

          -  No cardiovascular conditions that contraindicate high dosages of sodium

        Pulmonary:

          -  No serious lung disease (e.g., chronic obstructive pulmonary disease)

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 4 weeks after study
             participation

          -  Not at high medical or psychiatric risk

          -  No nonmalignant systemic disease

          -  No active infection

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since prior immunotherapy and recovered

          -  No concurrent immunomodulatory agents

        Chemotherapy:

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

        Endocrine therapy:

          -  Concurrent corticosteroids allowed

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered

        Surgery:

          -  Recovered from prior surgery

        Other:

          -  Prior cytodifferentiating agents allowed

          -  No prior antineoplastons

          -  No other concurrent antineoplastic agents