Non Hodgkin Lymphoma Clinical Trial
Antineoplaston Therapy in Treating Patients With Non-Hodgkin’s 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.
Full Description
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
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There is 1 Location for this study
Houston Texas, 77055, United States
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