antineoplaston therapy in treating patients with mantle cell lymphoma

Conditions: Contiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Stage III Mantle Cell Lymphoma; Stage IV Mantle Cell Lymphoma; Recurrent Mantle Cell Lymphoma

Summary: 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.

objectives: * 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 lymphoma. * evaluate the 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 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.

Eligibility criteria:
disease characteristics: * 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) 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 20,000/mm\^3 hepatic: * no hepatic insufficiency * bilirubin no greater than 2.5 mg/dl * sgot and sgpt no greater than 5 times upper limit of normal renal: * creatinine no greater than 2.5 mg/dl * no history of renal conditions that contraindicate high dosages of sodium cardiovascular: * no 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 active infections 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: * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * no concurrent antineoplastic agent endocrine therapy: * at least 4 weeks since prior corticosteroids (e.g., dexamethasone or prednisone) * no concurrent dexamethasone, prednisone, or other corticosteroids radiotherapy: * at least 8 weeks since prior radiotherapy and recovered surgery: * not specified other: * no prior antineoplaston therapy * no concurrent antibiotics, antifungals, or antivirals