Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 57 of 67 for:    Burzyński

Antineoplaston Therapy in Treating Patients With 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: NCT00003457
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : December 16, 2016
Last Update Posted : August 22, 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 Refractory Brain Tumors
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 40
Recruitment Details Fourty patients were recruited between July 1996 and March 2011. 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 persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 40
Completed 31
Not Completed 9
Reason Not Completed
Not evaluable             9
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 persistent or recurrent brain tumor 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
36.0
(18.1 to 64.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
18
  45.0%
Male
22
  55.0%
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; Stable Disease (SD), < 50% decrease and < 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.
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 persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Participants
Complete Response 4
Partial Response 5
Stable Disease 12
Progressive Disease 10
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 persistent or recurrent brain tumor 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 70.0
12 months overall survival 50.0
24 months overall survival 40.0
36 months overall survival 35.0
48 months overall survival 30.0
60 months overall survival 22.5
Time Frame 15 years, 7 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 persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

All-Cause Mortality
Antineoplaston Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Antineoplaston Therapy
Affected / at Risk (%)
Total   27/40 (67.50%) 
Blood and lymphatic system disorders   
Hemoglobin  1 [1]  1/40 (2.50%) 
INR (International Normalized Ratio of prothrombin time)  1 [2]  1/40 (2.50%) 
Cardiac disorders   
Cardiac ischemia/infarction  1 [3]  1/40 (2.50%) 
Pericardial effusion (non-malignant)  1 [4]  1/40 (2.50%) 
Endocrine disorders   
Pancreatic endocrine: glucose intolerance  1 [5]  1/40 (2.50%) 
Gastrointestinal disorders   
Obstruction, GI: Small bowel NOS  1 [6]  1/40 (2.50%) 
Perforation, GI: Duodenum  1 [7]  1/40 (2.50%) 
Hemorrhage, GI: Abdomen NOS  1 [8]  1/40 (2.50%) 
Pain: Abdomen NOS  1 [9]  1/40 (2.50%) 
General disorders   
Central venous catheter infection  2 [10]  5/40 (12.50%) 
Fatigue (asthenia, lethargy, malaise) Fatigue (asthenia, lethargy, malaise)  1 [11]  2/40 (5.00%) 
Pain: Pain NOS  1 [12]  1/40 (2.50%) 
Infections and infestations   
Infection - Other  1 [13]  1/40 (2.50%) 
Infection (documented clinically): Blood  1 [14]  5/40 (12.50%) 
Infection (documented clinically): Colon  1 [15]  1/40 (2.50%) 
Infection (documented clinically): Lung (pneumonia)  1 [16]  3/40 (7.50%) 
Infection (documented clinically): Skin (cellulitis)  1 [17]  2/40 (5.00%) 
Lung (pneumonia)  1 [18]  1/40 (2.50%) 
Flu-like syndrome  1 [19]  1/40 (2.50%) 
Investigations   
Hypernatremia  1 [20]  2/40 (5.00%) 
Nervous system disorders   
Hemorrhage, CNS  1 [21]  2/40 (5.00%) 
Confusion  1 [22]  2/40 (5.00%) 
Neuropathy: motor  1 [23]  1/40 (2.50%) 
Seizure  1 [24]  11/40 (27.50%) 
Somnolence/depressed level of consciousness  1 [25]  3/40 (7.50%) 
Renal and urinary disorders   
Infection (documented clinically): Bladder (urinary)  1 [26]  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1 [27]  1/40 (2.50%) 
Skin and subcutaneous tissue disorders   
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1 [28]  1/40 (2.50%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1 [29]  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 INR (International Normalized Ratio of prothrombin time) was not related to Antineoplaston therapy.
[3]
The Cardiac ischemia/infarction was not related to Antineoplaston therapy.
[4]
The Pericardial effusion (non-malignant) was not related to Antineoplaston therapy.
[5]
The Pancreatic endocrine: glucose intolerance was not related to Antineoplaston therapy.
[6]
The Obstruction, GI: Small bowel NOS was not related to Antineoplaston therapy.
[7]
The Perforation, GI: Duodenum was not related to Antineoplaston therapy.
[8]
The Hemorrhage, GI: Abdomen NOS was not related to Antineoplaston therapy.
[9]
The Pain: Abdomen NOS was not related to Antineoplaston therapy.
[10]
The Central venous catheter infections were not related to Antineoplaston therapy.
[11]
One of the Fatigues (asthenia, lethargy, malaise) was probably related to Antineoplaston therapy.
[12]
The Pain: Pain NOS was not related to Antineoplaston therapy.
[13]
The Infection - Other was not related to Antineoplaston therapy.
[14]
The Infections (documented clinically): Blood were not related to Antineoplaston therapy.
[15]
The Infection (documented clinically): Colon was not related to Antineoplaston therapy.
[16]
The Infections (documented clinically): Lung (pneumonias) were not related to Antineoplaston therapy.
[17]
The Infections (documented clinically): Skin (cellulitises) were not related to Antineoplaston therapy.
[18]
The Lung (pneumonia) was not related to Antineoplaston therapy.
[19]
The Flu-like syndrome was not related to Antineoplaston therapy.
[20]
The Hypernatremias were possibly related to Antineoplaston therapy.
[21]
The Hemorrhages, CNS were not related to Antineoplaston therapy.
[22]
The Confusions were not related to Antineoplaston therapy.
[23]
The Neuropathy: motor was not related to Antineoplaston therapy.
[24]
The Seizures were not related to Antineoplaston therapy.
[25]
One of the Somnolences/depressed levels of consciousness was possibly related to Antineoplaston therapy.
[26]
The Infection (documented clinically): Bladder (urinary) was not related to Antineoplaston therapy.
[27]
The Dyspnea (shortness of breath) was not related to Antineoplaston therapy.
[28]
The Bruising (in absence of Grade 3 or 4 thrombocytopenia) was not related to Antineoplaston therapy.
[29]
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  13/40 (32.50%) 
Leukocytes (total WBC)  1  3/40 (7.50%) 
Lymphopenia  1  14/40 (35.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  7/40 (17.50%) 
Platelets  1  9/40 (22.50%) 
Cardiac disorders   
Hypertension  1  3/40 (7.50%) 
Ear and labyrinth disorders   
Tinnitus  1  3/40 (7.50%) 
Eye disorders   
Vision-blurred vision  1  7/40 (17.50%) 
Gastrointestinal disorders   
Anorexia  1  5/40 (12.50%) 
Dehydration  1  3/40 (7.50%) 
Diarrhea  1  6/40 (15.00%) 
Dry mouth/salivary gland (xerostomia)  1  10/40 (25.00%) 
Nausea  1  18/40 (45.00%) 
Vomiting  1  16/40 (40.00%) 
Pain: Abdomen NOS  1  5/40 (12.50%) 
General disorders   
Non-functional central venous catheter  2  13/40 (32.50%) 
Central venous catheter - Other  1  5/40 (12.50%) 
Fatigue (asthenia, lethargy, malaise)  1  28/40 (70.00%) 
Fever  1  5/40 (12.50%) 
Insomnia  1  3/40 (7.50%) 
Rigors/chills  1  7/40 (17.50%) 
Edema/Fluid retention  2  15/40 (37.50%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  10/40 (25.00%) 
Infections and infestations   
Central venous catheter infection  2  13/40 (32.50%) 
Infection (documented clinically): Bladder (urinary)  1  7/40 (17.50%) 
Infection (documented clinically): Blood  1  6/40 (15.00%) 
Infection (documented clinically): Lung (pneumonia)  1  4/40 (10.00%) 
Infection (documented clinically): Mucosa  1  6/40 (15.00%) 
Infection (documented clinically): Sinus  1  3/40 (7.50%) 
Infection (documented clinically): Soft tissue NOS  1  3/40 (7.50%) 
Infection (documented clinically): Upper airway NOS  1  7/40 (17.50%) 
Infection (documented clinically): Urinary tract NOS  1  5/40 (12.50%) 
Opportunistic infection  1  5/40 (12.50%) 
Flu-like syndrome  1  5/40 (12.50%) 
Investigations   
Albumin, serum-low (hypoalbuminemia)  1  5/40 (12.50%) 
Alkaline phosphatase  1  8/40 (20.00%) 
Bicarbonate, serum-low  1  4/40 (10.00%) 
GGT (gamma-Glutamyl transpeptidase)  1  7/40 (17.50%) 
Hyperbilirubinemia  1  3/40 (7.50%) 
Hypercholesteremia  1  6/40 (15.00%) 
Hyperglycemia  1  19/40 (47.50%) 
Hypernatremia  1  26/40 (65.00%) 
Hypertriglyceridemia  1  4/40 (10.00%) 
Hypocalcemia  1  19/40 (47.50%) 
Hypoglycemia  1  7/40 (17.50%) 
Hypokalemia  1  37/40 (92.50%) 
Hypomagnesemia  1  9/40 (22.50%) 
Hyponatremia  1  3/40 (7.50%) 
Hypophosphatemia  1  8/40 (20.00%) 
Metabolic/Laboratory - Other  1  4/40 (10.00%) 
Proteinuria  1  12/40 (30.00%) 
SGOT  1  13/40 (32.50%) 
SGPT  1  14/40 (35.00%) 
Uric acid, serum-high (hyperuricemia)  1  3/40 (7.50%) 
Musculoskeletal and connective tissue disorders   
Pain: Back  1  3/40 (7.50%) 
Pain: Chest wall  1  3/40 (7.50%) 
Pain: Joint  1  15/40 (37.50%) 
Pain: Muscle  1  11/40 (27.50%) 
Nervous system disorders   
Hemorrhage, CNS  1  3/40 (7.50%) 
Ataxia (incoordination)  1  5/40 (12.50%) 
Confusion  1  14/40 (35.00%) 
Dizziness  1  13/40 (32.50%) 
Memory impairment  1  6/40 (15.00%) 
Mood alteration: Agitation  1  4/40 (10.00%) 
Mood alteration: Anxiety  1  3/40 (7.50%) 
Mood alteration: Depression  1  4/40 (10.00%) 
Neuropathy: motor  1  7/40 (17.50%) 
Neuropathy: sensory  1  3/40 (7.50%) 
Seizure  1  15/40 (37.50%) 
Somnolence/depressed level of consciousness  1  16/40 (40.00%) 
Speech impairment  1  10/40 (25.00%) 
Tremor  1  5/40 (12.50%) 
Pain: Head/headache  1  18/40 (45.00%) 
Renal and urinary disorders   
Hemorrhage, GU: Urinary NOS  1  4/40 (10.00%) 
Incontinence, urinary  1  3/40 (7.50%) 
Urinary frequency/urgency  1  10/40 (25.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/40 (12.50%) 
Dyspnea (shortness of breath)  1  6/40 (15.00%) 
Skin and subcutaneous tissue disorders   
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  4/40 (10.00%) 
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 Primary Brain Tumors—Final Report (Protocol BT-09). Journal of Cancer Therapy 6(12): 1063-1074, 2015. DOI: 10.4236/jct.2015.612116
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003457     History of Changes
Other Study ID Numbers: CDR0000066489
BC-BT-9 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: October 25, 2016
Results First Posted: December 16, 2016
Last Update Posted: August 22, 2017