Expired Study
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Houston, Texas 77055


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003498


Primary Contact:

Principal Investigator
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute


Backup Contact:

N/A


Location Contact:

Houston, Texas 77055
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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