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.
- 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
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.
- 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.
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- WBC greater than 2000/mm^3
- Platelet count greater than 50,000/mm^3
- Bilirubin no greater than 2.5 mg/dL
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of cardiovascular conditions that contraindicate high dosages of sodium
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- No serious infection requiring treatment
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulatory agent (e.g., interferon or interleukin-2)
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent antineoplastic agents
- At least 4 weeks since prior dexamethasone, prednisone, or other corticosteroids
- No concurrent corticosteroids
- At least 8 weeks since prior radiotherapy and recovered
- Not specified
- Prior cytodifferentiation therapy allowed
- No prior antineoplaston therapy
- No concurrent antibiotics, antifungals, or antivirals