Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
This trial is active, not recruiting.
|Treatments||antineoplaston a10, antineoplaston as2-1|
|Sponsor||Burzynski Research Institute|
|Start date||August 1998|
|Trial size||40 participants|
|Trial identifier||NCT00003501, BC-LY-8, CDR0000066541|
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 studies the effectiveness of antineoplaston therapy in treating patients who have recurrent or refractory high-grade stage II, stage III, or stage IV non-Hodgkin's lymphoma after receiving chemotherapy.
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically proven stage II, III, or IV high-grade non-Hodgkin's lymphoma that has not responded to, or has relapsed after a standard primary chemotherapy regimen plus at least 1 standard second-line salvage chemotherapy regimen NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adoptedby 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. 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 50,000/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 uncontrolled 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 active infection 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: - See Disease Characteristics - 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 dexamethasone, prednisone, or other corticosteroids - No concurrent corticosteroid Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - No prior antineoplaston therapy - No concurrent antibiotics, antifungals, or antivirals
|Official title||Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, High Grade|
|Description||OBJECTIVES: - Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening recurrent or refractory high-grade non-Hodgkin's lymphoma. - Describe 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 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment. Tumors are measured at least every 8 weeks for 6 months, every 3 months for 1.5 years, every 6 months for 2 years, and then annually for 2 years. Patients are followed for survival. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.|
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