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

Burzynski Research Institute31 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Low-Grade Lymphoma

Interventions

Antineoplaston therapy (Atengenal + Astugenal)DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Burzynski Clinic

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Percentage of Participants Who Survived

6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival

Time frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.