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Trial record 46 of 67 for:    Burzyński

Antineoplaston Therapy in Treating Children With Primary Malignant 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: NCT00003476
Recruitment Status : Terminated (Slow accrual)
First Posted : January 27, 2003
Results First Posted : April 10, 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 Childhood Brain Tumor
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 8
Recruitment Details Eight patients were recruited between March 1966 and November 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): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 8
Completed 7
Not Completed 1
Reason Not Completed
Not evaluable             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): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
9.1
(2.6 to 16.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
6
  75.0%
Male
2
  25.0%
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 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): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
Partial Response 1
Stable Disease 1
Progressive Disease 5
2.Secondary Outcome
Title Percentage of Participants Who Survived
Hide Description Six months and Twelve months overall survival
Time Frame 6 months, 12 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): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Percentage of participants
6 months overall survival 50.0
12 months overall survival 0
Time Frame 15 years, 10 months
Adverse Event Reporting Description Eight patients were recruited between March 1996 and November 2011. 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): Children with a primary malignant 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   2/8 (25.00%) 
Gastrointestinal disorders   
Vomiting  2 [1]  1/8 (12.50%) 
General disorders   
Central venous catheter: Thrombosis/embolism  1 [2]  1/8 (12.50%) 
Fever  2 [3]  1/8 (12.50%) 
Infections and infestations   
Infection (documented clinically): Lung (pneumonia)  2 [4]  1/8 (12.50%) 
Nervous system disorders   
Hydrocephalus  2 [5]  1/8 (12.50%) 
Seizure  2 [6]  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders   
Aspiration  2 [7]  1/8 (12.50%) 
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 Central venous catheter: Thrombosis/embolism was not related to Antineoplaston therapy.
[3]
The Fever was not related to Antineoplaston therapy.
[4]
The Infection (documented clinically): Lung (pneumonia) was not related to Antineoplaston therapy.
[5]
The Hydrocephalus was not related to Antineoplaston therapy.
[6]
The Seizure was not related to Antineoplaston therapy.
[7]
The Aspiration 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   8/8 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  2/8 (25.00%) 
Leukocytes (total WBC)  1  1/8 (12.50%) 
Lymphopenia  1  3/8 (37.50%) 
Neutrophils/granulocytes (ANC/AGC)  1  1/8 (12.50%) 
Ear and labyrinth disorders   
Hearing (without monitoring program)  1  1/8 (12.50%) 
Endocrine disorders   
Cushingoid appearance  1  2/8 (25.00%) 
Eye disorders   
Diplopia  1  1/8 (12.50%) 
Vision-blurred vision  1  1/8 (12.50%) 
Gastrointestinal disorders   
Anorexia  1  1/8 (12.50%) 
Dry mouth/salivary gland (xerostomia)  1  2/8 (25.00%) 
Dysphagia (difficulty swallowing)  1  1/8 (12.50%) 
Nausea  1  3/8 (37.50%) 
Vomiting  1  5/8 (62.50%) 
General disorders   
Central venous catheter: Thrombosis/embolism  2  1/8 (12.50%) 
Fatigue (asthenia, lethargy, malaise)  1  3/8 (37.50%) 
Fever  1  4/8 (50.00%) 
Rigors/chills  1  1/8 (12.50%) 
Weight gain  1  2/8 (25.00%) 
Infections and infestations   
Infection (documented clinically): Conjunctiva  1  1/8 (12.50%) 
Infection (documented clinically): Lung (pneumonia)  1  1/8 (12.50%) 
Infection (documented clinically): Mucosa  1  1/8 (12.50%) 
Infection (documented clinically): Sinus  1  1/8 (12.50%) 
Infection (documented clinically): Upper airway NOS  1  1/8 (12.50%) 
Sinus  1  1/8 (12.50%) 
Hypercholesteremia  1  1/8 (12.50%) 
Investigations   
Alkaline phosphatase  1  2/8 (25.00%) 
Bicarbonate, serum-low  1  1/8 (12.50%) 
GGT (gamma-Glutamyl transpeptidase)  1  1/8 (12.50%) 
Hyperchloremia  1  1/8 (12.50%) 
Hyperglycemia  1  1/8 (12.50%) 
Hypernatremia  1  1/8 (12.50%) 
Hypocalcemia  1  1/8 (12.50%) 
Hypoglycemia  1  1/8 (12.50%) 
Hypokalemia  1  8/8 (100.00%) 
Hypomagnesemia  1  2/8 (25.00%) 
Metabolic/Laboratory - Other  1  1/8 (12.50%) 
Uric acid, serum-high (hyperuricemia)  1  1/8 (12.50%) 
Nervous system disorders   
Apnea  1  1/8 (12.50%) 
Ataxia (incoordination)  1  1/8 (12.50%) 
Hydrocephalus  1  1/8 (12.50%) 
Neuropathy - motor  1  1/8 (12.50%) 
Neuropathy: CN III Pupil, upper eyelid, extra ocular movements  1  1/8 (12.50%) 
Neuropathy: cranial: CN V Motor-jaw muscles; Sensory-facial  1  1/8 (12.50%) 
Neuropathy: cranial: CN VII Motor-face; Sensory-taste  1  1/8 (12.50%) 
Neuropathy: cranial: CN VIII Hearing and balance  1  1/8 (12.50%) 
Neuropathy: motor  1  1/8 (12.50%) 
Seizure  1  1/8 (12.50%) 
Somnolence/depressed level of consciousness  1  6/8 (75.00%) 
Speech impairment  1  1/8 (12.50%) 
Pain: Head/headache  1  3/8 (37.50%) 
Respiratory, thoracic and mediastinal disorders   
Aspiration  1  1/8 (12.50%) 
Dyspnea (shortness of breath)  1  2/8 (25.00%) 
Nasal cavity/paranasal sinus reactions  1  1/8 (12.50%) 
Skin and subcutaneous tissue disorders   
Flushing  1  1/8 (12.50%) 
Rash/desquamation  1  1/8 (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, Marszalek A, Brookman, S. A phase II study of Antineoplastons A10 and AS2-1 in children with recurrent, refractory or progressive primary brain tumors - Final Report (Protocol BT-22). Journal of Cancer Therapy, 5:977-988, 2014.
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003476     History of Changes
Other Study ID Numbers: CDR0000066513
BC-BT-22 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: December 28, 2016
Results First Posted: April 10, 2017
Last Update Posted: August 24, 2017