Non Hodgkin Lymphoma Clinical Trial
Antineoplaston Therapy in Treating Patients With Intermediate-Grade Stage II – IV Non-Hodgkin’s Lymphoma
Summary
Current therapies for Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma.
Full Description
Refractory or Recurrent Intermediate-Grade Stage II - IV 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 to12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
To determine the efficacy of Antineoplaston therapy in patients with Refractory or Recurrent Intermediate-Grade Stage II - IV 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 Refractory or Recurrent Intermediate-Grade Stage II - IV 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 stage II, III, or IV intermediate-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 adopted by 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 serious 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 agents
Endocrine therapy:
At least 4 weeks since prior dexamethasone, prednisone, or other corticosteroids
No concurrent corticosteroids
Radiotherapy:
At least 8 weeks since prior radiotherapy and recovered
Surgery:
Not specified
Other:
Prior cytodifferentiation therapy allowed
No prior antineoplaston therapy
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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