- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003498
Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77055-6330
- Burzynski Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Antineoplaston therapy
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With an Objective Response, Stable Disease, or Progressive Disease
Time Frame: 5 months
|
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.
|
5 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066537
- BC-LY-3 (OTHER: Burzynski Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Hodgkin Lymphoma
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin LymphomaUnited States
-
Marker Therapeutics, Inc.RecruitingNon Hodgkin Lymphoma | Non-Hodgkin Lymphoma, Adult | Non-Hodgkin Lymphoma, Refractory | Non-Hodgkin Lymphoma, RelapsedUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Recurrent Mantle Cell Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
National Cancer Institute (NCI)RecruitingRefractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Transformed Non-Hodgkin Lymphoma | Recurrent Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Recurrent Primary Cutaneous... and other conditionsUnited States
-
Caribou Biosciences, Inc.RecruitingLymphoma | Lymphoma, Non-Hodgkin | B Cell Lymphoma | Non Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Relapsed Non Hodgkin Lymphoma | B Cell Non-Hodgkin's LymphomaUnited States, Australia, Israel
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRefractory Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Hematopoietic Cell Transplantation RecipientUnited States
-
Chongqing Precision Biotech Co., LtdRecruitingNon Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Relapsed Non-Hodgkin LymphomaChina
-
University of WashingtonRecruitingRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Recurrent Non-Hodgkin Lymphoma | Refractory Non-Hodgkin LymphomaUnited States
-
Estrella Biopharma, Inc.Eureka Therapeutics Inc.Not yet recruitingLymphoma | Lymphoma, Non-Hodgkin | Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | High-grade B-cell Lymphoma | CNS Lymphoma | Lymphomas Non-Hodgkin's B-Cell | Relapsed Non-Hodgkin Lymphoma | Lymphoma, Non-Hodgkins | Large B-Cell Lymphoma and other conditions
-
Acerta Pharma BVAstraZenecaActive, not recruitingNon Hodgkin LymphomaUnited States, Canada, Italy
Clinical Trials on Antineoplaston therapy (Atengenal + Astugenal)
-
Burzynski Research InstituteCompletedLow Grade AstrocytomasUnited States
-
Burzynski Research InstituteTerminatedMalignant MesotheliomaUnited States
-
Burzynski Research InstituteTerminatedStage IV Non-small Cell Lung CancerUnited States
-
Burzynski Research InstituteTerminatedStage IV Ovarian Cancer | Stage III Ovarian CancerUnited States
-
Burzynski Research InstituteTerminatedSmall Intestine CancerUnited States
-
Burzynski Research InstituteTerminatedNeuroblastomaUnited States
-
Burzynski Research InstituteCompletedMalignant Brain TumorsUnited States
-
Burzynski Research InstituteTerminated
-
Burzynski Research InstituteTerminatedUnknown Primary CarcinomaUnited States
-
Burzynski Research InstituteTerminatedMetastatic Prostate CancerUnited States