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Trial record 32 of 67 for:    Burzyński

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

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ClinicalTrials.gov Identifier: NCT00003499
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Burzynski Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Low-Grade Lymphoma
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 31
Recruitment Details Thirty-one patients were recruited between March 1996 and November 2002. All study subjects were seen at the Burzynski Clinic in Houston TX
Pre-assignment Details  
Arm/Group Title Antineoplaston Therapy
Hide Arm/Group 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.

Antineoplaston therapy (Atengenal + Astugenal): 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.

Period Title: Overall Study
Started 31
Completed 23
Not Completed 8
Reason Not Completed
Not evaluable             8
Arm/Group Title Antineoplaston Therapy
Hide Arm/Group 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.

Antineoplaston therapy (Atengenal + Astugenal): 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.

Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
54.2
(37.1 to 69.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
15
  48.4%
Male
16
  51.6%
1.Primary Outcome
Title Number of Participants With Objective Response
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antineoplaston Therapy
Hide Arm/Group 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.

Antineoplaston therapy (Atengenal + Astugenal): 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.

Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Participants
Complete Response 1
Partial Response 2
Stable Disease 14
Progressive Disease 6
2.Secondary Outcome
Title Percentage of Participants Who Survived
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All study subjects receiving any Antineoplaston therapy
Arm/Group Title Antineoplaston Therapy
Hide Arm/Group 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.

Antineoplaston therapy (Atengenal + Astugenal): 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.

Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Percentage of Participants
6 months overall survival 29
12 months overall survival 28
24 months overall survival 21
36 months overall survival 17
48 months overall survival 14
60 months overall survival 11
Time Frame 6 years, 8 months
Adverse Event Reporting Description Adverse event data was collected through regular patient assessment and regular laboratory testing
 
Arm/Group Title Antineoplaston Therapy
Hide Arm/Group 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.

Antineoplaston therapy (Atengenal + Astugenal): 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.

All-Cause Mortality
Antineoplaston Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Antineoplaston Therapy
Affected / at Risk (%)
Total   10/31 (32.26%) 
Blood and lymphatic system disorders   
Hemoglobin  1 [1]  1/31 (3.23%) 
Cardiac disorders   
Left ventricular systolic dysfunction  1 [2]  1/31 (3.23%) 
General disorders   
Pain: Oral cavity  1 [3]  1/31 (3.23%) 
Infections and infestations   
Infection (documented clinically): Blood  1 [4]  3/31 (9.68%) 
Nervous system disorders   
Seizure  1 [5]  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders   
Lung (pneumonia)  1 [6]  2/31 (6.45%) 
Dyspnea (shortness of breath)  1 [7]  1/31 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
The hemoglobin was not related to Antineoplaston therapy.
[2]
The Left ventricular systolic dysfunction was not related to Antineoplaston therapy.
[3]
The Pain: Oral cavity was not related to Antineoplaston therapy.
[4]
The Infections (documented clinically): Blood werenot related to Antineoplaston therapy.
[5]
The Seizure was not related to Antineoplaston therapy.
[6]
The Lung (pneumonias) were not related to Antineoplaston therapy.
[7]
The Dyspnea (shortness of breath) was not related to Antineoplaston therapy.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antineoplaston Therapy
Affected / at Risk (%)
Total   31/31 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  7/31 (22.58%) 
Leukocytes (total WBC)  1  2/31 (6.45%) 
Lymphopenia  1  2/31 (6.45%) 
Neutrophils/granulocytes (ANC/AGC)  1  3/31 (9.68%) 
Platelets  1  4/31 (12.90%) 
Cardiac disorders   
Cardiac Arrhythmia  1  5/31 (16.13%) 
Ear and labyrinth disorders   
Tinnitus  1  3/31 (9.68%) 
Gastrointestinal disorders   
Diarrhea  1  8/31 (25.81%) 
Dry mouth/salivary gland (xerostomia)  1  2/31 (6.45%) 
Nausea  1  22/31 (70.97%) 
Taste alteration (dysgeusia)  1  2/31 (6.45%) 
Vomiting  1  10/31 (32.26%) 
General disorders   
Central venous catheter infection  2  2/31 (6.45%) 
Central venous catheter - non-functional  2  2/31 (6.45%) 
Fatigue (asthenia, lethargy, malaise)  1  20/31 (64.52%) 
Fever  1  5/31 (16.13%) 
Rigors/chills  1  5/31 (16.13%) 
Edema  2  16/31 (51.61%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  10/31 (32.26%) 
Infections and infestations   
Infection (documented clinically): Blood  1  6/31 (19.35%) 
Infection (documented clinically): Upper airway NOS  1  2/31 (6.45%) 
Lung (pneumonia)  1  3/31 (9.68%) 
Mucosa  1  3/31 (9.68%) 
Skin  1  5/31 (16.13%) 
Upper airway  1  8/31 (25.81%) 
Investigations   
Alkaline phosphatase  1  2/31 (6.45%) 
Hyperbilirubinemia  1  3/31 (9.68%) 
Hyperglycemia  1  5/31 (16.13%) 
Hypernatremia  1  22/31 (70.97%) 
Hypocalcemia  1  4/31 (12.90%) 
Hypochloremia  1  2/31 (6.45%) 
Hypoglycemia  1  3/31 (9.68%) 
Hypokalemia  1  22/31 (70.97%) 
Hypomagnesemia  1  2/31 (6.45%) 
SGOT  1  8/31 (25.81%) 
SGPT  1  4/31 (12.90%) 
Musculoskeletal and connective tissue disorders   
Pain: Joint  1  9/31 (29.03%) 
Pain: Muscle  1  3/31 (9.68%) 
Nervous system disorders   
Confusion  1  2/31 (6.45%) 
Dizziness  1  9/31 (29.03%) 
Mood alteration  1  3/31 (9.68%) 
Neuropathy: sensory  1  2/31 (6.45%) 
Somnolence/depressed level of consciousness  1  9/31 (29.03%) 
Speech impairment  1  2/31 (6.45%) 
Pain: Head/headache  1  10/31 (32.26%) 
Renal and urinary disorders   
Hemorrhage, GU  1  2/31 (6.45%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  9/31 (29.03%) 
Skin and subcutaneous tissue disorders   
Hyperepidermisation  1  2/31 (6.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, Institutional
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: S. R. Burzynski, MD, PhD
Organization: Burzynski Research Institute, Inc.
Phone: 713-335-5664
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003499     History of Changes
Other Study ID Numbers: CDR0000066538
BC-LY-6 ( Other Identifier: BRI )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: February 1, 2018
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019