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.

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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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT00003498

Recruitment Status:

Terminated

Sponsor:

Burzynski Research Institute

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There is 1 Location for this study

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Burzynski Clinic
Houston Texas, 77055, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT00003498

Recruitment Status:

Terminated

Sponsor:


Burzynski Research Institute

How clear is this clinincal trial information?

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