Back to resultsAntineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Primary Purpose
Non Hodgkin Lymphoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Antineoplaston therapy (Atengenal + Astugenal)
Sponsored by
About this trial
This is an interventional treatment trial for Non Hodgkin Lymphoma focused on measuring Non Hodgkin Lymphoma Recurrent, Non Hodgkin Lymphoma Refractory
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
Sites / Locations
- Burzynski Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Antineoplaston therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants With an Objective Response, Stable Disease, or Progressive Disease
An objective response is defined as a complete or partial response. A complete response is complete disappearance of all tumor by physical examination and radiographic studies and bone marrow involvement, if appropriate, for a minimum of four weeks. A partial response is a > 50% reduction in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of four weeks. Stable disease indicates < 50% change in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of twelve weeks. Progressive Disease is a > 50% increase in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of four weeks.
Secondary Outcome Measures
Full Information
NCT ID
NCT00003498
First Posted
November 1, 1999
Last Updated
January 4, 2021
Sponsor
Burzynski Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00003498
Brief Title
Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Official Title
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
October 13, 1997 (Actual)
Primary Completion Date
February 2, 2007 (Actual)
Study Completion Date
February 2, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Burzynski Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma
Keywords
Non Hodgkin Lymphoma Recurrent, Non Hodgkin Lymphoma Refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antineoplaston therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Antineoplaston therapy (Atengenal + Astugenal)
Other Intervention Name(s)
A10 (Atengenal); AS2-1 (Astugenal)
Intervention Description
Patients with 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.
Primary Outcome Measure Information:
Title
Number of Participants With an Objective Response, Stable Disease, or Progressive Disease
Description
An objective response is defined as a complete or partial response. A complete response is complete disappearance of all tumor by physical examination and radiographic studies and bone marrow involvement, if appropriate, for a minimum of four weeks. A partial response is a > 50% reduction in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of four weeks. Stable disease indicates < 50% change in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of twelve weeks. Progressive Disease is a > 50% increase in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of four weeks.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislaw R. Burzynski, MD, PhD
Organizational Affiliation
Burzynski Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burzynski Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77055-6330
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.burzynskiresearch.com
Description
Burzynski Research Institute
URL
http://www.burzynskiclinic.com
Description
Burzynski Clinic
Learn more about this trial
Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma
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