Antineoplaston Therapy in Treating Patients With Refractory or Recurrent Intermediate-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have refractory or recurrent intermediate-grade stage II, stage III, or stage IV non-Hodgkin's lymphoma.

OBJECTIVES:

• Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life threatening refractory or recurrent intermediate grade non-Hodgkin's lymphoma.
• Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete response, partial response, or stable disease continue treatment.

Tumors are measured at least every 8 weeks for 6 months, every 3 months for 1.5 years, every 6 months for 2 years, and then annually for 2 years.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

• Drug: antineoplaston A10
• Drug: antineoplaston AS2-1

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