Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
Condition: Low-Grade Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Patients with Low-grade 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: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Low-grade non-Hodgkin's lymphoma

Summary:

      Current therapies for Low-grade 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 Low-grade Non-Hodgkin's Lymphoma.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on patients with Low-grade Non-Hodgkin's Lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven stage II, III, or IV low grade non-Hodgkin's lymphoma that is
             unlikely to respond to existing therapy or for which no established therapy exists
             NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by
             PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former
             terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol
             uses the former terminology.

        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 normal

        Renal:

          -  Creatinine normal

          -  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

          -  No serious active infections

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since immunotherapy and recovered

          -  No concurrent immunomodulating agents (e.g., interferon, 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