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 is studying how well antineoplaston therapy works in treating
patients with low-grade non-Hodgkin's lymphoma.
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with serious or immediately life-threatening low grade non-Hodgkin's lymphoma.
- Describe the response, tolerance to, and side effects of this regimen in these
OUTLINE: This is an open label study.
Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment
continues for at least 12 months in the absence of disease progression and unacceptable
toxicity. After 12 months, patients with responding or stable disease may continue
Tumors are measured every 8 weeks for the first 6 months, every 3 months for the first 2
years, every 6 months for years 3 and 4, and yearly for years 5 and 6.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- Histologically proven stage II, III, or IV low grade non-Hodgkin's lymphoma that is
unlikely to respond to existing therapy or for which no established therapy exists
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 2,000/mm^3
- Platelet count greater than 20,000/mm^3
- Bilirubin normal
- Creatinine normal
- No history of renal conditions that contraindicate high dosages of sodium
- No hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- No serious active infections
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since immunotherapy and recovered
- No concurrent immunomodulating agents (e.g., interferon, interleukin-2)
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- At least 4 weeks since prior corticosteroids
- No concurrent corticosteroids
- At least 8 weeks since prior radiotherapy and recovered
- Not specified
- No prior antineoplaston therapy
- No other concurrent antineoplastic agents
- No concurrent antibiotics, antifungals, or antivirals