Current therapies for Low-grade Non-Hodgkin's Lymphoma provide limited benefit to the
patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
beneficial in the treatment of Low-grade Non-Hodgkin's Lymphoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Low-grade Non-Hodgkin's Lymphoma.
Low-grade 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 to 12 months in the absence of disease progression or unacceptable
- To determine the efficacy of Antineoplaston therapy in patients with Low-grade
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
Low-grade 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.
- 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