Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma

OBJECTIVES:

- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with non-Hodgkin's lymphoma who have failed high-dose chemotherapy and bone
marrow transplantation.

- Describe the response to, tolerance to, and side effects of this regimen in these
patients.

Non-Hodgkin's Lymphoma patients receive gradually escalating doses of intravenous
Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
Treatment continues up to 12 months in the absence of disease progression or unacceptable
toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with Non-Hodgkin's
Lymphoma, as measured by an objective response to therapy (complete response, partial
response or stable disease).

- To determine the safety and tolerance of Antineoplaston therapy in patients with
Non-Hodgkin's Lymphoma.

- To determine objective response, tumor size is measured utilizing MRI scans, which are
performed every 8 weeks for the first two years, every 3 months for the third and fourth
years, every 6 months for the 5th and sixth years, and annually thereafter.

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