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Trial record 52 of 67 for:    Burzyński

Antineoplaston Therapy in Treating 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: NCT00003470
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : December 16, 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 Anaplastic Astrocytoma
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 27
Recruitment Details Twenty-seven patients were recruited between March 1996 and November 2007. 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 an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 27
Completed 21
Not Completed 6
Reason Not Completed
Not evaluable             6
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 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 Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
41.5
(19.9 to 57.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
7
  25.9%
Male
20
  74.1%
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 an anaplastic astrocytoma 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 21
Measure Type: Number
Unit of Measure: Participants
Complete Response 2
Partial Response 3
Stable Disease 6
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 an anaplastic astrocytoma 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: Percentage of participants
6 months overall survival 63.0
12 months overall survival 40.7
24 months overall survival 29.6
36 months overall survival 22.2
48 months overall survival 14.8
60 months overall survival 11.1
Time Frame 12 years, nine 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 an anaplastic astrocytoma that has not responded to standard therapy 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   12/27 (44.44%) 
Gastrointestinal disorders   
Vomiting  2 [1]  1/27 (3.70%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  2 [2]  2/27 (7.41%) 
Edema/Fluid retention  1 [3]  1/27 (3.70%) 
Infections and infestations   
Central venous catheter infection  1 [4]  3/27 (11.11%) 
Infection (documented clinically): Bladder (urinary)  2 [5]  1/27 (3.70%) 
Infection (documented clinically): Lung (pneumonia)  2 [6]  2/27 (7.41%) 
Infection (documented clinically): Skin (cellulitis)  2 [7]  1/27 (3.70%) 
Infection with normal ANC: Brain + Spinal cord (encephalomyelitis)  2 [8]  1/27 (3.70%) 
Lung (pneumonia)  2 [9]  1/27 (3.70%) 
Investigations   
Hypernatremia  2 [10]  1/27 (3.70%) 
Hypokalemia  2 [11]  1/27 (3.70%) 
SGPT  2 [12]  1/27 (3.70%) 
Nervous system disorders   
Ataxia (incoordination)  2 [13]  1/27 (3.70%) 
Confusion  2 [14]  2/27 (7.41%) 
Mood alteration: Agitation  2 [15]  1/27 (3.70%) 
Seizure  2 [16]  3/27 (11.11%) 
Somnolence/depressed level of consciousness  2 [17]  3/27 (11.11%) 
Tremor  2 [18]  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary/Upper Respiratory - Other (Pneumonia)  2 [19]  1/27 (3.70%) 
Vascular disorders   
Thrombosis/thrombus/embolism  2 [20]  1/27 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Institutional
2
Term from vocabulary, CTCAE (3.0)
[1]
The Vomiting was not related to Antineoplaston therapy.
[2]
The Fatigues (asthenia, lethargy, malaise) were not related to Antineoplaston therapy.
[3]
The Edema/Fluid retention was not related to Antineoplaston therapy.
[4]
The Central venous catheter infections were not related to Antineoplaston therapy.
[5]
The Infection (documented clinically): Bladder (urinary) 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 Infection with normal ANC: Brain + Spinal cord (encephalomyelitis) was not related to Antineoplaston therapy.
[9]
The Lung (pneumonia) was not related to Antineoplaston therapy.
[10]
The Hypernatremia was possibly related to Antineoplaston therapy.
[11]
The Hypokalemia was possibly related to Antineoplaston therapy.
[12]
The SGPT was not related to Antineoplaston therapy.
[13]
The Ataxia (incoordination) was not related to Antineoplaston therapy.
[14]
The Confusions were not related to Antineoplaston therapy.
[15]
The Mood alteration: Agitation was not related to Antineoplaston therapy.
[16]
The Seizures were not related to Antineoplaston therapy.
[17]
The Somnolences/depressed levels of consciousness were not related to Antineoplaston therapy.
[18]
The Tremor was not related to Antineoplaston therapy.
[19]
The Pulmonary/Upper Respiratory - Other (Pneumonia) was not related to Antineoplaston therapy.
[20]
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   27/27 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  6/27 (22.22%) 
Leukocytes (total WBC)  1  3/27 (11.11%) 
Lymphopenia  1  4/27 (14.81%) 
Platelets  1  4/27 (14.81%) 
Cardiac disorders   
Hypertension  1  2/27 (7.41%) 
Ear and labyrinth disorders   
Tinnitus  1  2/27 (7.41%) 
Endocrine disorders   
Hot flashes/flushes  1  2/27 (7.41%) 
Eye disorders   
Vision-blurred vision  1  2/27 (7.41%) 
Gastrointestinal disorders   
Diarrhea  1  5/27 (18.52%) 
Dry mouth/salivary gland (xerostomia)  1  5/27 (18.52%) 
Heartburn/dyspepsia  1  3/27 (11.11%) 
Nausea  1  12/27 (44.44%) 
Taste alteration (dysgeusia)  1  2/27 (7.41%) 
Vomiting  1  7/27 (25.93%) 
General disorders   
Non-functional central venous catheter  2  9/27 (33.33%) 
Central venous catheter - Other  2  2/27 (7.41%) 
Pain: Central venous catheter  2  4/27 (14.81%) 
Central venous catheter thrombosis/embolism  2  2/27 (7.41%) 
Fatigue (asthenia, lethargy, malaise)  1  20/27 (74.07%) 
Fever  1  4/27 (14.81%) 
Insomnia  1  3/27 (11.11%) 
Rigors/chills  1  3/27 (11.11%) 
Weight gain  1  3/27 (11.11%) 
Edema/Fluid retention  2  14/27 (51.85%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  4/27 (14.81%) 
Allergic rhinitis (including sneezing, nasal stuffiness,  1  2/27 (7.41%) 
Infections and infestations   
Central venous catheter infection  2  7/27 (25.93%) 
Infection (documented clinically): Bladder (urinary)  1  3/27 (11.11%) 
Infection (documented clinically): Lung (pneumonia)  1  2/27 (7.41%) 
Infection (documented clinically): Skin (cellulitis)  1  2/27 (7.41%) 
Infection (documented clinically): Upper airway NOS  1  3/27 (11.11%) 
Opportunistic infection  1  2/27 (7.41%) 
Investigations   
Albumin, serum-low (hypoalbuminemia)  1  2/27 (7.41%) 
Alkaline phosphatase  1  3/27 (11.11%) 
Hypercholesteremia  1  2/27 (7.41%) 
Hyperglycemia  1  10/27 (37.04%) 
Hyperkalemia  1  2/27 (7.41%) 
Hypernatremia  1  21/27 (77.78%) 
Hypocalcemia  1  7/27 (25.93%) 
Hypoglycemia  1  6/27 (22.22%) 
Hypokalemia  1  22/27 (81.48%) 
Hypomagnesemia  1  5/27 (18.52%) 
Hyponatremia  1  3/27 (11.11%) 
Hypophosphatemia  1  4/27 (14.81%) 
Metabolic/Laboratory - Other  1  2/27 (7.41%) 
Proteinuria  1  7/27 (25.93%) 
SGOT  1  6/27 (22.22%) 
SGPT  1  3/27 (11.11%) 
Musculoskeletal and connective tissue disorders   
Pain: Back  1  3/27 (11.11%) 
Pain: Extremity-limb  1  3/27 (11.11%) 
Pain: Joint  1  3/27 (11.11%) 
Nervous system disorders   
Ataxia (incoordination)  1  4/27 (14.81%) 
Confusion  1  10/27 (37.04%) 
Dizziness  1  9/27 (33.33%) 
Mood alteration: Agitation  1  2/27 (7.41%) 
Neuropathy: motor  1  2/27 (7.41%) 
Psychosis (hallucinations/delusions)  1  2/27 (7.41%) 
Seizure  1  7/27 (25.93%) 
Somnolence/depressed level of consciousness  1  17/27 (62.96%) 
Speech impairment  1  7/27 (25.93%) 
Tremor  1  4/27 (14.81%) 
Pain: Head/headache  1  9/27 (33.33%) 
Renal and urinary disorders   
Hemorrhage, GU: Urinary NOS  1  3/27 (11.11%) 
Urinary frequency/urgency  1  5/27 (18.52%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  4/27 (14.81%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other  1  2/27 (7.41%) 
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 injections in adult patients with recurrent anaplastic astrocytoma - Final report (Protocol BT-15). Cancer and Clinical Oncology 4(2): 13-23, 2015. DOI: http://dx.doi.org/10.5539/cco.v4n2p13
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003470     History of Changes
Other Study ID Numbers: CDR0000066507
BC-BT-15 ( 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 24, 2017