Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Condition: Non Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Patients with Non-Hodgkin's Lymphoma 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: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Non Hodgkin Lymphoma Recurrent; Non Hodgkin Lymphoma Refractory

Summary:

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

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven non-Hodgkin's disease that has failed both prior high-dose
             chemotherapy and bone marrow transplantation

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  At least 2 months

        Hematopoietic:

          -  WBC greater than 2,000/mm^3

          -  Platelet count greater than 20,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 2.5 mg/dL

        Renal:

          -  Creatinine no greater than 2.5 mg/dL

          -  No history of renal conditions that contraindicate high dosages of sodium

        Cardiovascular:

          -  No hypertension

          -  No history of congestive heart failure

          -  No history of other cardiovascular conditions that contraindicate high dosages of
             sodium

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 4 weeks after study
             participation

          -  No serious active infections

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since prior immunotherapy and recovered

          -  No concurrent immunomodulatory agents (e.g., interferon or interleukin-2)

        Chemotherapy:

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

        Endocrine therapy:

          -  At least 4 weeks since prior corticosteroids

          -  No concurrent corticosteroids

        Radiotherapy:

          -  At least 8 weeks since prior radiotherapy and recovered

        Surgery:

          -  Not specified

        Other:

          -  No prior antineoplaston therapy

          -  No other concurrent antineoplastic agents

          -  No concurrent antibiotics, antifungals, or antivirals