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

Study Overview
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Brief Summary
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Current therapies for Low-grade 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 Low-grade Non-Hodgkin's Lymphoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Low-grade Non-Hodgkin's Lymphoma.

Detailed Description
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Low-grade 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 Low-grade 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 Low-grade 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.

Official Title
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Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma Low Grade

Conditions
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Low-Grade Lymphoma

Intervention / Treatment
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* Drug: Antineoplaston therapy (Atengenal + Astugenal)


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven stage II, III, or IV low grade non-Hodgkin's lymphoma that is unlikely to respond to existing therapy or for which no established therapy exists 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 2,000/mm^3 Platelet count greater than 20,000/mm^3 Hepatic: Bilirubin normal Renal: Creatinine normal 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 No serious active infections PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since immunotherapy and recovered No concurrent immunomodulating agents (e.g., interferon, 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antineoplaston therapy<br>Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. | Drug: Antineoplaston therapy (Atengenal + Astugenal)<br>* Patients with Low-grade non-Hodgkin's lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.<br>* Other names: A10 (Atengenal); AS2-1 (Astugenal)ANP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Objective Response | Objective response rate per The International Working Group response criteria (1999): Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least four weeks. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Survived | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-grade non-Hodgkin's lymphoma