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

Refractory or Recurrent Intermediate-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 Intermediate-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 Intermediate-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 intermediate-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 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 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 serious 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 agents

Endocrine therapy:

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

- No concurrent corticosteroids

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- Prior cytodifferentiation therapy allowed

- No prior antineoplaston therapy

- No concurrent antibiotics, antifungals, or antivirals