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Trial record 6 of 67 for:    Burzyński

Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma (AA)

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: NCT00003537
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : February 20, 2017
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 Adult Brain Tumor
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 19
Recruitment Details Nineteen patients were recruited between April 1995 and October 2008. 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 or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 19
Completed 18
Not Completed 1
Reason Not Completed
Not evalauable             1
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 or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
44.0
(22.4 to 60.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
7
  36.8%
Male
12
  63.2%
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 eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
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 or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
Complete Response 3
Partial Response 1
Stable Disease 5
Progressive Disease 9
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 or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Percentage of participants
6 months overall survival 68.4
12 months overall survival 52.6
24 months overall survival 36.8
36 months overall survival 26.3
48 months overall survival 26.3
60 months overall survival 21.1
Time Frame 13 years, 6 months
Adverse Event Reporting Description Nineteen patients were recruited between April 1995 and October 2008. 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 an anaplastic astrocytoma 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   11/19 (57.89%) 
Cardiac disorders   
Supraventricular and nodal arrhythmia: Atrial fibrillation  1 [1]  1/19 (5.26%) 
Ventricular arrhythmia: Ventricular tachycardia  1 [2]  1/19 (5.26%) 
Hypotension  1 [3]  1/19 (5.26%) 
Pericardial effusion (non-malignant)  1 [4]  1/19 (5.26%) 
Eye disorders   
Diplopia  1 [5]  1/19 (5.26%) 
General disorders   
Central venous catheter infection  2 [6]  4/19 (21.05%) 
Thrombosis/embolism  2 [7]  1/19 (5.26%) 
Fever  1 [8]  2/19 (10.53%) 
Rigors/chills  1 [9]  2/19 (10.53%) 
Infections and infestations   
Infection (documented clinically): Bladder (urinary)  1 [10]  1/19 (5.26%) 
Investigations   
Hypokalemia  1 [11]  1/19 (5.26%) 
Nervous system disorders   
Hemorrhage, CNS  1 [12]  1/19 (5.26%) 
Neuropathy: motor  1 [13]  1/19 (5.26%) 
Seizure  1 [14]  2/19 (10.53%) 
Somnolence/depressed level of consciousness  1 [15]  3/19 (15.79%) 
Respiratory, thoracic and mediastinal disorders   
Infection (documented clinically): Lung (pneumonia)  1 [16]  3/19 (15.79%) 
Pneumothorax  1 [17]  1/19 (5.26%) 
Vascular disorders   
Thrombosis/embolism (vascular access-related)  1 [18]  1/19 (5.26%) 
Thrombosis/thrombus/embolism  1 [19]  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, Institutional
[1]
The Supraventricular and nodal arrhythmia: Atrial fibrillation was not related to Antineoplaston therapy.
[2]
The Ventricular arrhythmia: Ventricular tachycardia was not related to Antineoplaston therapy.
[3]
Th hypotension was not related to Antineoplaston therapy.
[4]
The Pericardial effusion (non-malignant) was not related to Antineoplaston therapy.
[5]
The diplopia was not related to Antineoplaston therapy.
[6]
The Central venous catheter infections were not related to Antineoplaston therapy
[7]
The Thrombosis/embolism was not related to Antineoplaton therapy.
[8]
The Fevers were not related to Antineoplaston therapy.
[9]
The Rigors/chills were not related to Antineoplaston therapy.
[10]
The Infection (documented clinically): Bladder (urinary) was not related to Antineoplaston therapy.
[11]
The Hypokalemia was not related to Antineoplaston therapy.
[12]
The Hemorrhage, CNS was not related to Antineoplaston therapy.
[13]
The Neuropathy: motor was not related to Antineoplaston therapy.
[14]
The Seizures were not related to Antineoplaston therapy.
[15]
The Somnolences/depressed levels of consciousness were not related to Antineoplaston therapy.
[16]
The Infections (documented clinically): Lung (pneumonia) were not related to Antineoplaston therapy.
[17]
The Pneumothorax was not related to Antineoplaston therapy.
[18]
The Thrombosis/embolism (vascular access-related) was not related to Antineoplaston therapy.
[19]
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   19/19 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  5/19 (26.32%) 
Leukocytes (total WBC)  1  1/19 (5.26%) 
Lymphopenia  1  7/19 (36.84%) 
Neutrophils/granulocytes (ANC/AGC)  1  2/19 (10.53%) 
Platelets  1  3/19 (15.79%) 
Edema:head and neck  1  1/19 (5.26%) 
Cardiac disorders   
Palpitations  1  2/19 (10.53%) 
Supraventricular and nodal arrhythmia: Atrial fibrillation  1  1/19 (5.26%) 
Supraventricular and nodal arrhythmia: Sinus tachycardia  1  1/19 (5.26%) 
Ventricular arrhythmia: Ventricular tachycardia  1  1/19 (5.26%) 
Hypertension  1  3/19 (15.79%) 
Hypotension  1  1/19 (5.26%) 
Left ventricular systolic dysfunction  1  1/19 (5.26%) 
Pericardial effusion (non-malignant)  1  1/19 (5.26%) 
Ear and labyrinth disorders   
Auditory/Ear - Other  1  1/19 (5.26%) 
Diplopia  1  2/19 (10.53%) 
Pain: External ear  1  1/19 (5.26%) 
Pain: Middle ear  1  1/19 (5.26%) 
Eye disorders   
Nystagmus  1  2/19 (10.53%) 
Vision-blurred vision  1  5/19 (26.32%) 
Vision-photophobia  1  1/19 (5.26%) 
Gastrointestinal disorders   
Fatigue (asthenia, lethargy, malaise)  1  9/19 (47.37%) 
Diarrhea  1  4/19 (21.05%) 
Dry mouth/salivary gland (xerostomia)  1  3/19 (15.79%) 
Gastrointestinal - Other  1  1/19 (5.26%) 
Heartburn/dyspepsia  1  2/19 (10.53%) 
Nausea  1  5/19 (26.32%) 
Taste alteration (dysgeusia)  1  3/19 (15.79%) 
Vomiting  1  7/19 (36.84%) 
Pain: Abdomen NOS  1  1/19 (5.26%) 
General disorders   
Non-functional central venous catheter  2  6/19 (31.58%) 
Central venous catheter - Other  2  6/19 (31.58%) 
Pain: Central venous catheter  2  2/19 (10.53%) 
Central venous catheter thrombosis/embolism  2  5/19 (26.32%) 
Fever  1  5/19 (26.32%) 
Rigors/chills  1  4/19 (21.05%) 
Sweating (diaphoresis)  1  1/19 (5.26%) 
Weight gain  1  1/19 (5.26%) 
Edema/Fluid retention  2  8/19 (42.11%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  6/19 (31.58%) 
Infections and infestations   
Central venous catheter infection  2  6/19 (31.58%) 
Infection - Other  1  1/19 (5.26%) 
Infection (documented clinically): Bladder (urinary)  1  4/19 (21.05%) 
Infection (documented clinically): Middle ear (otitis  1  1/19 (5.26%) 
Infection (documented clinically): Blood  1  1/19 (5.26%) 
Infection (documented clinically): Bronchus  1  1/19 (5.26%) 
Infection (documented clinically): Lung (pneumonia)  1  4/19 (21.05%) 
Infection (documented clinically): Mucosa  1  3/19 (15.79%) 
Infection (documented clinically): Neck NOS  1  1/19 (5.26%) 
Infection (documented clinically): Oral cavity-gums (gingivitis)  1  1/19 (5.26%) 
Infection (documented clinically): Sinus  1  1/19 (5.26%) 
Infection (documented clinically): Upper airway NOS  1  3/19 (15.79%) 
Opportunistic infection  1  1/19 (5.26%) 
Flu-like syndrome  1  3/19 (15.79%) 
Investigations   
Albumin, serum-low (hypoalbuminemia)  1  2/19 (10.53%) 
Alkaline phosphatase  1  3/19 (15.79%) 
GGT (gamma-Glutamyl transpeptidase)  1  3/19 (15.79%) 
Hyperbilirubinemia  1  1/19 (5.26%) 
Hypercalcemia  1  2/19 (10.53%) 
Hypercholesteremia  1  2/19 (10.53%) 
Hyperglycemia  1  7/19 (36.84%) 
Hypernatremia  1  12/19 (63.16%) 
Hypertriglyceridemia  1  3/19 (15.79%) 
Hyperuricemia  1  1/19 (5.26%) 
Hypocalcemia  1  4/19 (21.05%) 
Hypokalemia  1  18/19 (94.74%) 
Hypoglycemia  1  5/19 (26.32%) 
Hypomagnesemia  1  1/19 (5.26%) 
Hyponatremia  1  1/19 (5.26%) 
Hypophosphatemia  1  4/19 (21.05%) 
Metabolic/Laboratory - Other  1  1/19 (5.26%) 
SGOT  1  7/19 (36.84%) 
SGPT  1  8/19 (42.11%) 
Uric acid, serum-high (hyperuricemia)  1  1/19 (5.26%) 
Metabolism and nutrition disorders   
Pain: Muscle  1  2/19 (10.53%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue - Other  1  1/19 (5.26%) 
Pain: Back  1  2/19 (10.53%) 
Pain: Extremity-limb  1  1/19 (5.26%) 
Pain: Joint  1  6/19 (31.58%) 
Pain: Neck  1  1/19 (5.26%) 
Nervous system disorders   
Hemorrhage, CNS  1  1/19 (5.26%) 
Ataxia (incoordination)  1  2/19 (10.53%) 
Confusion  1  3/19 (15.79%) 
Dizziness  1  3/19 (15.79%) 
Mood alteration  1  2/19 (10.53%) 
Mood alteration: Agitation  1  2/19 (10.53%) 
Neurology - Other  1  1/19 (5.26%) 
Mood alteration: Anxiety  1  1/19 (5.26%) 
Neuropathy: motor  1  2/19 (10.53%) 
Neuropathy: sensory  1  4/19 (21.05%) 
Psychosis (hallucinations/delusions)  1  1/19 (5.26%) 
Pyramidal tract dysfunction  1  1/19 (5.26%) 
Seizure  1  6/19 (31.58%) 
Somnolence/depressed level of consciousness  1  10/19 (52.63%) 
Speech impairment  1  4/19 (21.05%) 
Pain: Head/headache  1  13/19 (68.42%) 
Renal and urinary disorders   
Hemorrhage, GU: Bladder  1  1/19 (5.26%) 
Hemorrhage, GU: Urinary NOS  1  1/19 (5.26%) 
Proteinuria  1  5/19 (26.32%) 
Urinary frequency/urgency  1  5/19 (26.32%) 
Respiratory, thoracic and mediastinal disorders   
Pain: Chest/thorax NOS  1  1/19 (5.26%) 
Dyspnea (shortness of breath)  1  1/19 (5.26%) 
Pleural effusion (non-malignant)  1  1/19 (5.26%) 
Pneumothorax  1  1/19 (5.26%) 
Thrombosis/thrombus/embolism  1  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other  1  1/19 (5.26%) 
Dry skin  1  1/19 (5.26%) 
Hair loss/alopecia (scalp or body)  1  1/19 (5.26%) 
Nail changes  1  1/19 (5.26%) 
Pruritus/itching  1  1/19 (5.26%) 
Petechiae  1  1/19 (5.26%) 
Vascular disorders   
Thrombosis/embolism (vascular access-related)  1  2/19 (10.53%) 
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, Marszalek A. A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Newly-Diagnosed Anaplastic Astrocytoma Final Report (Protocol BT-08). Cancer and Clinical Oncology 4: 28-38, 2015. DOI: http://dx.doi.org/10.5539/cco.v4n1p28
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003537     History of Changes
Other Study ID Numbers: CDR0000066585
BC-BT-8 ( 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: February 20, 2017
Last Update Posted: August 24, 2017