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Trial record 48 of 67 for:    Burzyński

Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT00003474
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : December 13, 2017
Last Update Posted : March 22, 2018
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 Glioblastoma Multiforme of the Brain
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 40
Recruitment Details Forty patients were recruited between March 1996 and April 2003. 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): Adults with a residual/recurrent/progressive Glioblastoma Multiforme 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 40
Completed 26
Not Completed 14
Reason Not Completed
Not Evaluable             14
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 residual/recurrent/progressive Glioblastoma Multiforme 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 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
48.8
(26.7 to 71.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
24
  60.0%
Male
16
  40.0%
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 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 residual/recurrent/progressive Glioblastoma Multiforme 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 26
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
1
   3.8%
Partial Response
1
   3.8%
Stable Disease
5
  19.2%
Progressive Disease
19
  73.1%
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): Adults with a residual/recurrent/progressive Glioblastoma Multiforme 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 40
Measure Type: Number
Unit of Measure: Percentage of participants
6 months overall survival 45.0
12 months overall survival 22.5
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 7 years, 3 months
Adverse Event Reporting Description Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
 
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 residual/recurrent/progressive Glioblastoma Multiforme 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   17/40 (42.50%) 
Blood and lymphatic system disorders   
Hemoglobin  1 [1]  1/40 (2.50%) 
Cardiac disorders   
Hypertension  1 [2]  1/40 (2.50%) 
Gastrointestinal disorders   
Dehydration  1 [3]  1/40 (2.50%) 
Vomiting  1 [4]  1/40 (2.50%) 
General disorders   
Central Venous Catheter Infection  2 [5]  3/40 (7.50%) 
Infections and infestations   
Infection (documented clinically): Bladder (urinary)  1 [6]  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness: Whole body/generalized  1 [7]  1/40 (2.50%) 
Nervous system disorders   
Seizure  1 [8]  3/40 (7.50%) 
Somnolence/depressed level of consciousness  1 [9]  3/40 (7.50%) 
Syncope (fainting)  1 [10]  2/40 (5.00%) 
Pain: Head/headache  1 [11]  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Infection (documented clinically): Lung (pneumonia)  1 [12]  2/40 (5.00%) 
Dyspnea (shortness of breath)  1 [13]  2/40 (5.00%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1 [14]  1/40 (2.50%) 
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 Hypertension was not related to Antineoplaston Therapy.
[3]
The Dehydration was not related to Antineoplaston Therapy.
[4]
The Vomiting was not related to Antineoplaston Therapy.
[5]
The Central Venous Catheter Infections were not related to Antineoplaston Therapy
[6]
The Infection (documented clinically): Bladder (urinary) was not related to Antineoplaston Therapy.
[7]
The Muscle weakness: Whole body/generalized was not related to Antineoplaston Therapy
[8]
The Seizures were not related to Antineoplaston Therapy.
[9]
The Somnolences/depressed levels of consciousness were not related to Antineoplaston Therapy.
[10]
The Syncopes (faintings) were not related to Antineoplaston Therapy.
[11]
The Pain: Head/headaches were not related to Antineoplaston Therapy.
[12]
The Infections (documented clinically): Lung (pneumonias) were not related to Antineoplaston Therapy
[13]
The Dyspneas (shortnesses of breath) were not related to Antineoplaston Therapy.
[14]
The Thrombosis/thrombus/embolism 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   40/40 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  7/40 (17.50%) 
Leukocytes (total WBC)  1  4/40 (10.00%) 
Lymphopenia  1  8/40 (20.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  3/40 (7.50%) 
Platelets  1  5/40 (12.50%) 
Cardiac disorders   
Supraventricular and nodal arrhythmia: Sinus bradycardia  1  2/40 (5.00%) 
Hypertension  1  5/40 (12.50%) 
Hypotension  1  2/40 (5.00%) 
Ear and labyrinth disorders   
Tinnitus  1  3/40 (7.50%) 
Endocrine disorders   
Cushingoid appearance  1  2/40 (5.00%) 
Gastrointestinal disorders   
Anorexia  1  3/40 (7.50%) 
Constipation  1  2/40 (5.00%) 
Diarrhea  1  5/40 (12.50%) 
Dysphagia (difficulty swallowing)  1  2/40 (5.00%) 
Nausea  1  15/40 (37.50%) 
Vomiting  1  11/40 (27.50%) 
General disorders   
Central Venous Catheter: Non-functional  2  12/40 (30.00%) 
Central Venous Catheter: Other  1  2/40 (5.00%) 
Central Venous Catheter: Thrombosis/embolism  1  3/40 (7.50%) 
Constitutional Symptoms - Other  1  2/40 (5.00%) 
Fatigue (asthenia, lethargy, malaise)  1  23/40 (57.50%) 
Insomnia  1  4/40 (10.00%) 
Weight gain  1  3/40 (7.50%) 
Fever  1  3/40 (7.50%) 
Edema  2  21/40 (52.50%) 
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 (documented clinically): Bladder (urinary)  1  4/40 (10.00%) 
Infection (documented clinically): Blood  1  2/40 (5.00%) 
Infection (documented clinically): Lung (pneumonia)  1  4/40 (10.00%) 
Infection (documented clinically): Mucosa  1  3/40 (7.50%) 
Infection (documented clinically): Sinus  1  2/40 (5.00%) 
Infection (documented clinically): Upper airway NOS  1  2/40 (5.00%) 
Infection (documented clinically): Urinary tract NOS  1  3/40 (7.50%) 
Infection: Lung (pneumonia)  1  2/40 (5.00%) 
Infection: Mucosa  1  2/40 (5.00%) 
Infection: Opportunistic infection  1  5/40 (12.50%) 
Investigations   
Albumin, serum-low (hypoalbuminemia)  1  3/40 (7.50%) 
Alkaline phosphatase  1  2/40 (5.00%) 
GGT (gamma-Glutamyl transpeptidase)  1  3/40 (7.50%) 
Hypercholesteremia  1  4/40 (10.00%) 
Hyperglycemia  1  12/40 (30.00%) 
Hypernatremia  1  25/40 (62.50%) 
Hypertriglyceridemia  1  3/40 (7.50%) 
Hypocalcemia  1  3/40 (7.50%) 
Hypoglycemia  1  7/40 (17.50%) 
Hypokalemia  1  34/40 (85.00%) 
Hypomagnesemia  1  3/40 (7.50%) 
Hyponatremia  1  2/40 (5.00%) 
Proteinuria  1  5/40 (12.50%) 
SGOT  1  6/40 (15.00%) 
SGPT  1  8/40 (20.00%) 
Musculoskeletal and connective tissue disorders   
Pain: Back  1  2/40 (5.00%) 
Pain: Joint  1  3/40 (7.50%) 
Nervous system disorders   
Ataxia (incoordination)  1  4/40 (10.00%) 
Confusion  1  19/40 (47.50%) 
Dizziness  1  15/40 (37.50%) 
Memory impairment  1  2/40 (5.00%) 
Mood alteration: Agitation  1  2/40 (5.00%) 
Mood alteration: Anxiety  1  2/40 (5.00%) 
Mood alteration: Depression  1  4/40 (10.00%) 
Neuropathy: motor  1  6/40 (15.00%) 
Psychosis (hallucinations/delusions)  1  2/40 (5.00%) 
Seizure  1  13/40 (32.50%) 
Somnolence/depressed level of consciousness  1  22/40 (55.00%) 
Speech impairment  1  5/40 (12.50%) 
Syncope (fainting)  1  2/40 (5.00%) 
Tremor  1  3/40 (7.50%) 
Diplopia  1  2/40 (5.00%) 
Ophthalmoplegia/diplopia (double vision)  1  2/40 (5.00%) 
Vision-blurred vision  1  2/40 (5.00%) 
Pain: Head/headache  1  15/40 (37.50%) 
Pain: Muscle  1  3/40 (7.50%) 
Renal and urinary disorders   
Hemorrhage, GU: Urinary NOS  1  4/40 (10.00%) 
Incontinence, urinary  1  3/40 (7.50%) 
Urinary frequency/urgency  1  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/40 (5.00%) 
Dyspnea (shortness of breath)  1  9/40 (22.50%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  3/40 (7.50%) 
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
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003474     History of Changes
Other Study ID Numbers: CDR0000066511
BRI-BT-20 ( Other Identifier: Burzynski Research Institute )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: July 27, 2017
Results First Posted: December 13, 2017
Last Update Posted: March 22, 2018