Antineoplaston Therapy in Treating Patients With High-Grade Stage II - Stage IV Non-Hodgkin's Lymphoma

Refractory or Recurrent High-Grade Stage II - IV 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 to12 months in the
absence of disease progression or unacceptable toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with Refractory or
Recurrent High-Grade Stage II - IV 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
Refractory or Recurrent High-Grade Stage II - IV 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 stage II, III, or IV high-grade non-Hodgkin's lymphoma that has
not responded to, or has relapsed after a standard primary chemotherapy regimen plus
at least 1 standard second-line salvage chemotherapy regimen NOTE: A new
classification scheme for adult non-Hodgkin's lymphoma has been adoptedby 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 2000/mm^3

- Platelet count greater than 50,000/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 uncontrolled hypertension

- No history of congestive heart failure

- No history of 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 active infection requiring treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent immunomodulatory agent (e.g., interferon or interleukin-2)

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

- No concurrent antineoplastic agent

Endocrine therapy:

- At least 4 weeks since prior dexamethasone, prednisone, or other corticosteroids

- No concurrent corticosteroid

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- No prior antineoplaston therapy

- No concurrent antibiotics, antifungals, or antivirals