Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 67 for:    Burzyński

Antineoplaston Therapy in Treating Children 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: NCT00003458
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 19, 2017
Last Update Posted : February 2, 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 Childhood Brain Tumors
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 34
Recruitment Details Thirty-four patients were recruited between September 1996 and July 2012. 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.

Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 34
Completed 30
Not Completed 4
Reason Not Completed
Not evaluable             4
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): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
10.4
(0.8 to 17.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
21
  61.8%
Male
13
  38.2%
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.
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): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
Complete Response 1
Partial Response 5
Stable Disease 6
Progressive Disease 18
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.

Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Percentage of participants
6 months overall survival 64.7
12 months overall survival 47.1
24 months overall survival 35.3
36 months overall survival 32.4
48 months overall survival 20.6
60 months overall survival 20.6
Time Frame 18 years, 5 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.

Children with a 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   21/34 (61.76%) 
Blood and lymphatic system disorders   
Hemoglobin  1 [1]  1/34 (2.94%) 
Gastrointestinal disorders   
Vomiting  1 [2]  1/34 (2.94%) 
General disorders   
Fever  1 [3]  1/34 (2.94%) 
Infections and infestations   
Central Venous Catheter Infection  2 [4]  2/34 (5.88%) 
Infection (documented clinically): Lung (pneumonia)  1 [5]  1/34 (2.94%) 
Infection (documented clinically): Skin (cellulitis)  1 [6]  1/34 (2.94%) 
Investigations   
Hyperntremia  1 [7]  1/34 (2.94%) 
Nervous system disorders   
Hemorrhage, CNS  1 [8]  2/34 (5.88%) 
Hydrocephalus  1 [9]  1/34 (2.94%) 
Neuropathy: motor  1 [10]  1/34 (2.94%) 
Seizure  1 [11]  4/34 (11.76%) 
Somnolence/depressed level of consciousness  1 [12]  9/34 (26.47%) 
Pain: Head/headache  1 [13]  3/34 (8.82%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1 [14]  1/34 (2.94%) 
Skin and subcutaneous tissue disorders   
Hematoma  1 [15]  1/34 (2.94%) 
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 vomiting was not related to Antineoplaston therapy.
[3]
The fever was not related to Antineoplaston therapy.
[4]
The central venous catheter infection was not related to Antineoplaston therapy.
[5]
The infection (documented clinically): lung (pneumonia) was not related to Antineoplaston therapy.
[6]
The infection (documented clinically): skin (cellulitis) was not related to Antineoplaston therapy.
[7]
The hypernatremia was possibly related to Antineoplaston therapy.
[8]
Neither of the hemorrhage, CNS were related to Antineoplaston therapy.
[9]
The hydrocephalus was not related to Antineoplason therapy
[10]
The neuropathy: motor was not related to Antineoplason therapy
[11]
The seizures were not related to Antineoplason therapy
[12]
One of the somnolence/depressed level of consciousness was possibly related to Antineoplason therapy
[13]
One of the pain:headache was possibly related to Antineoplason therapy
[14]
The dyspnea (shortness of breath) was not related to Antineoplaston therpy
[15]
The hemotoma 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   34/34 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  15/34 (44.12%) 
Leukocytes (total WBC)  1  12/34 (35.29%) 
Lymphopenia  1  10/34 (29.41%) 
Neutrophils/granulocytes (ANC/AGC)  1  7/34 (20.59%) 
Platelets  1  2/34 (5.88%) 
Ear and labyrinth disorders   
Pain: Middle ear  1  2/34 (5.88%) 
Endocrine disorders   
Cushingoid appearance  1  5/34 (14.71%) 
Eye disorders   
Diplopia  1  3/34 (8.82%) 
Gastrointestinal disorders   
Anorexia  1  3/34 (8.82%) 
Constipation  1  4/34 (11.76%) 
Diarrhea  1  9/34 (26.47%) 
Distension/bloating, abdominal  1  2/34 (5.88%) 
Dry mouth/salivary gland (xerostomia)  1  3/34 (8.82%) 
Heartburn/dyspepsia  1  4/34 (11.76%) 
Nausea  1  15/34 (44.12%) 
Taste alteration (dysgeusia)  1  2/34 (5.88%) 
Vomiting  1  21/34 (61.76%) 
Pain: Abdomen NOS  1  6/34 (17.65%) 
Pain: Stomach  1  2/34 (5.88%) 
General disorders   
Non-functional central venous catheter  2  13/34 (38.24%) 
Thrombosis/embolism - Central venous catheter  2  2/34 (5.88%) 
Fatigue (asthenia, lethargy, malaise)  1  24/34 (70.59%) 
Fever  1  11/34 (32.35%) 
Rigors/chills  1  3/34 (8.82%) 
Weight gain  1  3/34 (8.82%) 
Edema/Fluid retention  2  8/34 (23.53%) 
Infections and infestations   
Central venous catheter infection  1  7/34 (20.59%) 
Infection (documented clinically): Lung (pneumonia)  1  2/34 (5.88%) 
Infection (documented clinically): Mucosa  1  3/34 (8.82%) 
Infection (documented clinically): Upper airway NOS  1  5/34 (14.71%) 
Opportunistic infection  1  4/34 (11.76%) 
Investigations   
Albumin, serum-low (hypoalbuminemia)  1  3/34 (8.82%) 
Alkaline phosphatase  1  6/34 (17.65%) 
Bicarbonate, serum-low  1  4/34 (11.76%) 
GGT (gamma-Glutamyl transpeptidase)  1  4/34 (11.76%) 
Hypercalcemia  1  3/34 (8.82%) 
Hypercholesteremia  1  8/34 (23.53%) 
Hyperglycemia  1  13/34 (38.24%) 
Hypermagnesemia  1  2/34 (5.88%) 
Hypernatremia  1  12/34 (35.29%) 
Hypertriglyceridemia  1  4/34 (11.76%) 
Hypocalcemia  1  4/34 (11.76%) 
Hypoglycemia  1  11/34 (32.35%) 
Hypokalemia  1  27/34 (79.41%) 
Hypomagnesemia  1  3/34 (8.82%) 
Hyponatremia  1  4/34 (11.76%) 
Hypophosphatemia  1  5/34 (14.71%) 
Proteinuria  1  10/34 (29.41%) 
SGOT  1  7/34 (20.59%) 
SGPT  1  10/34 (29.41%) 
Uric acid, serum-high (hyperuricemia)  1  5/34 (14.71%) 
Musculoskeletal and connective tissue disorders   
Pain: Back  1  3/34 (8.82%) 
Pain: Chest wall  1  2/34 (5.88%) 
Pain: Extremity-limb  1  4/34 (11.76%) 
Pain: Joint  1  5/34 (14.71%) 
Pain: Muscle  1  3/34 (8.82%) 
Pain: Neck  1  4/34 (11.76%) 
Nervous system disorders   
Hemorrhage, CNS  1  2/34 (5.88%) 
Ataxia (incoordination)  1  10/34 (29.41%) 
Confusion  1  4/34 (11.76%) 
Dizziness  1  6/34 (17.65%) 
Memory impairment  1  2/34 (5.88%) 
Neuropathy: CN III Pupil, upper eyelid, extra ocular movements  1  2/34 (5.88%) 
Neuropathy: cranial: CN VI Lateral deviation of eye  1  2/34 (5.88%) 
Neuropathy: cranial: CN VII Motor-face; Sensory-taste  1  2/34 (5.88%) 
Neuropathy: motor  1  7/34 (20.59%) 
Neuropathy: sensory  1  2/34 (5.88%) 
Seizure  1  6/34 (17.65%) 
Somnolence/depressed level of consciousness  1  22/34 (64.71%) 
Speech impairment  1  5/34 (14.71%) 
Tremor  1  6/34 (17.65%) 
Pain: Head/headache  1  21/34 (61.76%) 
Renal and urinary disorders   
Hemorrhage, GU: Bladder  1  3/34 (8.82%) 
Hemorrhage, GU: Urinary NOS  1  3/34 (8.82%) 
Incontinence, urinary  1  2/34 (5.88%) 
Urinary frequency/urgency  1  6/34 (17.65%) 
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary: Nose  1  5/34 (14.71%) 
Cough  1  5/34 (14.71%) 
Dyspnea (shortness of breath)  1  6/34 (17.65%) 
Skin and subcutaneous tissue disorders   
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  2/34 (5.88%) 
Pruritus/itching  1  3/34 (8.82%) 
Rash/desquamation  1  5/34 (14.71%) 
Petechiae  1  3/34 (8.82%) 
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:
Stanislaw R. Burzynski, Tomasz J. Janicki, Gregory S. Burzynski, Ania Marszalek. A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Brain Tumors. Final Report (Protocol BT-10). Journal of Cancer Therapy 8: 173-187, 2017
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003458     History of Changes
Other Study ID Numbers: CDR0000066490
BC-BT-10 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: September 22, 2016
Results First Posted: January 19, 2017
Last Update Posted: February 2, 2018