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 stage II, stage III, or stage IV mantle cell lymphoma.
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with serious or immediately life-threatening stage II, III, or IV mantle cell
- Evaluate the response to, tolerance to, and side effects of this regimen in these
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1
intravenously 6 times daily until the maximum tolerated dose is reached. Treatment continues
in the absence of disease progression or unacceptable toxicity.
Tumors are measured every 8 weeks for 6 months, every 3 months for 2 years, every 6 months
for the third and fourth years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- Histologically proven stage II, III, or IV mantle cell lymphoma that is not curable
by surgery, radiotherapy, and/or chemotherapy
- Measurable tumor of greater than 2 cm in largest diameter for lymph nodes located in
head, neck, axillary, inguinal, and femoral areas (at least 1 cm for other areas)
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- WBC greater than 2000/mm^3
- Platelet count greater than 20,000/mm^3
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
- No 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 active infections requiring treatment
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulatory agent (e.g., interferon or interleukin-2)
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent antineoplastic agent
- At least 4 weeks since prior corticosteroids (e.g., dexamethasone or prednisone)
- No concurrent dexamethasone, prednisone, or other corticosteroids
- At least 8 weeks since prior radiotherapy and recovered
- Not specified
- No prior antineoplaston therapy
- No concurrent antibiotics, antifungals, or antivirals