antineoplaston therapy in treating patients with non-hodgkin's lymphoma

Conditions: Non Hodgkin Lymphoma

Summary: current therapies for 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 non-hodgkin's lymphoma. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on patients with non-hodgkin's lymphoma.

objectives: * determine the safety and possible effectiveness of antineoplastons a10 and as2-1 in patients with non-hodgkin's lymphoma who have failed high-dose chemotherapy and bone marrow transplantation. * describe the response to, tolerance to, and side effects of this regimen in these patients. 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 toxicity. objectives: * to determine the efficacy of antineoplaston therapy in patients with 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 non-hodgkin's lymphoma. * to determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, 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.

Eligibility criteria:
disease characteristics: * histologically proven non-hodgkin's disease that has failed both prior high-dose chemotherapy and bone marrow transplantation patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * at least 2 months hematopoietic: * wbc greater than 2,000/mm\^3 * platelet count greater than 20,000/mm\^3 hepatic: * bilirubin no greater than 2.5 mg/dl 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 other 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 prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy and recovered * no concurrent immunomodulatory agents (e.g., interferon or interleukin-2) chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered endocrine therapy: * at least 4 weeks since prior corticosteroids * no concurrent corticosteroids radiotherapy: * at least 8 weeks since prior radiotherapy and recovered surgery: * not specified other: * no prior antineoplaston therapy * no other concurrent antineoplastic agents * no concurrent antibiotics, antifungals, or antivirals

Keywords: non hodgkin lymphoma recurrent non hodgkin lymphoma refractory