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Trial record 47 of 67 for:    Burzyński

Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003475
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : December 19, 2016
Last Update Posted : August 24, 2017
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 Malignant Brain Tumors
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 40
Recruitment Details Fourty patients were recruited between February 1996 and February 2011. All study subjects were seen at the Burzynski Clinic in Houston TX
Pre-assignment Details  
Arm/Group Title Antineoplaston Therpay
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): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 40
Completed 27
Not Completed 13
Reason Not Completed
Not evaluable             13
Arm/Group Title Antineoplaston Therpay
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.

Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
48.2
(19.7 to 68.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
14
  35.0%
Male
26
  65.0%
1.Primary Outcome
Title Number of Participants With Objective Response
Hide Description Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: 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 enhancing 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 Therpay
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): Adults with a primary malignant brain tumor that has not responded to standard therapy 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 27
Measure Type: Number
Unit of Measure: Participants
Complete Response 2
Partial Response 2
Stable Disease 4
Progressive Disease 19
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 Therpay
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): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Percentage of participants
6 months overall survival 47.5
12 months overall survival 27.5
24 months overall survival 2.5
36 months overall survival 2.5
48 months overall survival 2.5
60 months overall survival 2.5
Time Frame 15 years, 2 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): Adults with a primary malignant brain tumor that has not responded to standard therapy 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   21/40 (52.50%) 
Blood and lymphatic system disorders   
Hemoglobin  1 [1]  1/40 (2.50%) 
Endocrine disorders   
Pancreatic endocrine: glucose intolerance  1 [2]  1/40 (2.50%) 
Gastrointestinal disorders   
Perforation, GI: Colon  1 [3]  1/40 (2.50%) 
Infections and infestations   
Central venous catheter infection  2 [4]  2/40 (5.00%) 
Infection - Other  1 [5]  1/40 (2.50%) 
Infection (documented clinically): Lung (pneumonia)  1 [6]  4/40 (10.00%) 
Infection (documented clinically): Skin (cellulitis)  1 [7]  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders   
Pain: Back  1 [8]  1/40 (2.50%) 
Nervous system disorders   
Mood alteration: Agitation  1 [9]  1/40 (2.50%) 
Seizure  1 [10]  5/40 (12.50%) 
Somnolence/depressed level of consciousness  1 [11]  5/40 (12.50%) 
Pain: Head/headache  1 [12]  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1 [13]  1/40 (2.50%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1 [14]  3/40 (7.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, Institutional
[1]
The Hemoglobin was not related to Antineoplaston therapy.
[2]
The Pancreatic endocrine: glucose intolerance was not related to Antineoplaston therapy.
[3]
The Perforation, GI: Colon was not related to Antineoplaston therapy.
[4]
The Central venous catheter infections were not related to Antineoplaston therapy.
[5]
The Infection - Other was not related to Antineoplaston therapy.
[6]
The Infections (documented clinically): Lung (pneumonias) were not related to Antineoplaston therapy.
[7]
The Infection (documented clinically): Skin (cellulitis) was not related to Antineoplaston therapy.
[8]
The Pain: Back was not related to Antineoplaston therapy.
[9]
The Mood alteration: Agitation was not related to Antineoplaston therapy.
[10]
The Seizures were not related to Antineoplaston therapy.
[11]
The Somnolences/depressed levels of consciousness were not related to Antineoplaston therapy.
[12]
The Pain: Head/headaches were not related to Antineoplaston therapy.
[13]
The Dyspnea (shortness of breath) was not related to Antineoplaston therapy.
[14]
The Thromboses/thrombi/embolisms were 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   40/40 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  8/40 (20.00%) 
Leukocytes (total WBC)  1  3/40 (7.50%) 
Lymphopenia  1  10/40 (25.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  3/40 (7.50%) 
Platelets  1  7/40 (17.50%) 
PT  1  3/40 (7.50%) 
Cardiac disorders   
Hypertension  1  3/40 (7.50%) 
Eye disorders   
Vision-blurred vision  1  3/40 (7.50%) 
Gastrointestinal disorders   
Diarrhea  1  5/40 (12.50%) 
Dry mouth/salivary gland (xerostomia)  1  5/40 (12.50%) 
Heartburn/dyspepsia  1  4/40 (10.00%) 
Nausea  1  11/40 (27.50%) 
Taste alteration (dysgeusia)  1  3/40 (7.50%) 
Vomiting  1  12/40 (30.00%) 
General disorders   
Non-functional central venous catheter  2  7/40 (17.50%) 
Central venous catheter - Other  2  5/40 (12.50%) 
Fatigue (asthenia, lethargy, malaise)  1  20/40 (50.00%) 
Fever  1  6/40 (15.00%) 
Rigors/chills  1  3/40 (7.50%) 
Edema/Fluid retention  2  15/40 (37.50%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  7/40 (17.50%) 
Infections and infestations   
Central venous catheter infection  2  5/40 (12.50%) 
Infection - Other  1  4/40 (10.00%) 
Infection (documented clinically): Lung (pneumonia)  1  6/40 (15.00%) 
Infection (documented clinically): Mucosa  1  5/40 (12.50%) 
Infection (documented clinically): Upper airway NOS  1  4/40 (10.00%) 
Opportunistic infection  1  3/40 (7.50%) 
Investigations   
Albumin, serum-low (hypoalbuminemia)  1  3/40 (7.50%) 
Hypercholesteremia  1  4/40 (10.00%) 
Hyperglycemia  1  17/40 (42.50%) 
Hypernatremia  1  24/40 (60.00%) 
Hypocalcemia  1  12/40 (30.00%) 
Hypoglycemia  1  7/40 (17.50%) 
Hypokalemia  1  30/40 (75.00%) 
Hypophosphatemia  1  6/40 (15.00%) 
Metabolic/Laboratory - Other  1  3/40 (7.50%) 
Proteinuria  1  4/40 (10.00%) 
SGOT  1  6/40 (15.00%) 
SGPT  1  8/40 (20.00%) 
Uric acid, serum-high (hyperuricemia)  1  3/40 (7.50%) 
Musculoskeletal and connective tissue disorders   
Pain: Back  1  3/40 (7.50%) 
Pain: Extremity-limb  1  4/40 (10.00%) 
Pain: Joint  1  4/40 (10.00%) 
Pain: Muscle  1  4/40 (10.00%) 
Nervous system disorders   
Ataxia (incoordination)  1  6/40 (15.00%) 
Confusion  1  13/40 (32.50%) 
Dizziness  1  10/40 (25.00%) 
Memory impairment  1  4/40 (10.00%) 
Mood alteration: Depression  1  3/40 (7.50%) 
Neuropathy: motor  1  3/40 (7.50%) 
Seizure  1  11/40 (27.50%) 
Somnolence/depressed level of consciousness  1  20/40 (50.00%) 
Speech impairment  1  5/40 (12.50%) 
Pain: Head/headache  1  15/40 (37.50%) 
Renal and urinary disorders   
Hemorrhage, GU  1  3/40 (7.50%) 
Hemorrhage, GU: Urinary NOS  1  3/40 (7.50%) 
Urinary frequency/urgency  1  5/40 (12.50%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  8/40 (20.00%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  5/40 (12.50%) 
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
Publications:
Burzynski SR, Janicki TJ, Burzynski GS. A phase II study of antineoplastons A10 and AS2-1 in adult patients with recurrent glioblastoma multiforme: Final report (protocol BT-21). Journal of Cancer Therapy 5:946-956, 2014. DOI: http://dx.doi.org/10.4236/jct.2014.510100
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003475     History of Changes
Other Study ID Numbers: CDR0000066512
BC-BT-21 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: October 26, 2016
Results First Posted: December 19, 2016
Last Update Posted: August 24, 2017