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
Conditions
Brief 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.
Detailed description
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.
Interventions
PROCEDUREalternative product therapy
PROCEDUREbiological therapy
PROCEDUREbiologically based therapies
PROCEDUREcancer prevention intervention
PROCEDUREdifferentiation therapy
Sponsors
Burzynski Research Institute
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed