Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma

Launched by BURZYNSKI RESEARCH INSTITUTE · Jan 26, 2003

Keywords

ClinConnect 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 d...

Gender

ALL

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