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Trial record 45 of 67 for:    Burzyński

Antineoplaston Therapy in Treating Children With Visual Pathway Glioma (VPG)

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ClinicalTrials.gov Identifier: NCT00003477
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 Visual Pathway Glioma
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 12
Recruitment Details Twelve patients were recruited between June1996 and May 2004. 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 visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 12
Completed 8
Not Completed 4
Reason Not Completed
Not evalauable             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 visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
4.5
(0.6 to 16.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
3
  25.0%
Male
9
  75.0%
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 in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions and no Progressive Disease, sustained for at least four 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.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
Complete Response 2
Partial Response 2
Stable Disease 3
Progressive Disease 1
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.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Percentage of participants
6 months overall survival 91.7
12 months overall survival 83.3
24 months overall survival 75.0
36 months overall survival 58.3
48 months overall survival 50.0
60 months overall survival 50.0
Time Frame 8 years, 2 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): Patients with a visual pathway glioma 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   9/12 (75.00%) 
Gastrointestinal disorders   
Vomiting  1 [1]  1/12 (8.33%) 
General disorders   
Fever  1 [2]  1/12 (8.33%) 
Infections and infestations   
Central venous catheter infection  2 [3]  3/12 (25.00%) 
Nervous system disorders   
Seizure  1 [4]  2/12 (16.67%) 
Somnolence/depressed level of consciousness  1 [5]  3/12 (25.00%) 
Hemorrhage, CNS  1 [6]  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, Institutional
[1]
The vomiting was not related to Antineoplaston therapy.
[2]
The fever was not related to Antineoplaston therapy.
[3]
None of the central venous catheter infections were related to Antineoplaton therapy.
[4]
None of the seizures were related to Antineoplaston therapy.
[5]
None of the somnolences/depressed levels of consciousness were related to Antineoplaston therapy.
[6]
The hemorrhage, CNS, 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   12/12 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  5/12 (41.67%) 
Leukocytes (total WBC)  1  2/12 (16.67%) 
Lymphopenia  1  3/12 (25.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  2/12 (16.67%) 
Platelets  1  1/12 (8.33%) 
Ear and labyrinth disorders   
Auditory/Ear - Other  1  1/12 (8.33%) 
Endocrine disorders   
Cushingoid appearance  1  2/12 (16.67%) 
Hot flashes/flushes  1  1/12 (8.33%) 
Eye disorders   
Nystagmus  1  1/12 (8.33%) 
Ocular/Visual - Other  1  2/12 (16.67%) 
Gastrointestinal disorders   
Anorexia  1  2/12 (16.67%) 
Dehydration  1  2/12 (16.67%) 
Diarrhea  1  4/12 (33.33%) 
Distension/bloating, abdominal  1  1/12 (8.33%) 
Dry mouth/salivary gland (xerostomia)  1  3/12 (25.00%) 
Heartburn/dyspepsia  1  2/12 (16.67%) 
Nausea  1  7/12 (58.33%) 
Vomiting  1  8/12 (66.67%) 
Pain: Abdomen NOS  1  2/12 (16.67%) 
General disorders   
Central Venous Catheter Non-functional  2  3/12 (25.00%) 
Central Venous Catheter - Other  2  2/12 (16.67%) 
Fatigue (asthenia, lethargy, malaise)  1  6/12 (50.00%) 
Fever  1  5/12 (41.67%) 
Rigors/chills  1  3/12 (25.00%) 
Central Venous Catheter Pain  2  1/12 (8.33%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  4/12 (33.33%) 
Allergic rhinitis (including sneezing, nasal stuffiness)  1  3/12 (25.00%) 
Infections and infestations   
Central Venous Catheter Infection  2  5/12 (41.67%) 
Infection (documented clinically): Abdomen NOS  1  1/12 (8.33%) 
Infection (documented clinically): Bladder (urinary)  1  1/12 (8.33%) 
Infection (documented clinically): Lung (pneumonia)  1  1/12 (8.33%) 
Infection (documented clinically): Middle ear (otitis  1  1/12 (8.33%) 
Infection (documented clinically): Pharynx  1  1/12 (8.33%) 
Infection (documented clinically): Sinus  1  2/12 (16.67%) 
Infection (documented clinically): Soft tissue NOS  1  1/12 (8.33%) 
Infection (documented clinically): Upper airway NOS  1  3/12 (25.00%) 
Infection (documented clinically): Urinary tract NOS  1  1/12 (8.33%) 
Opportunistic infection  1  1/12 (8.33%) 
Viral hepatitis  1  1/12 (8.33%) 
Investigations   
Albumin, serum-low (hypoalbuminemia)  1  1/12 (8.33%) 
Alkaline phosphatase  1  2/12 (16.67%) 
Bicarbonate, serum-low  1  2/12 (16.67%) 
Hypercholesteremia  1  1/12 (8.33%) 
Hyperglycemia  1  2/12 (16.67%) 
Hypernatremia  1  7/12 (58.33%) 
Hypertriglyceridemia  1  1/12 (8.33%) 
Hypocalcemia  1  3/12 (25.00%) 
Hypokalemia  1  10/12 (83.33%) 
Hypomagnesemia  1  3/12 (25.00%) 
Hypoglycemia  1  4/12 (33.33%) 
Hyponatremia  1  2/12 (16.67%) 
Metabolic/Laboratory - Other  1  2/12 (16.67%) 
Proteinuria  1  4/12 (33.33%) 
SGOT  1  2/12 (16.67%) 
SGPT  1  3/12 (25.00%) 
Uric acid, serum-high (hyperuricemia)  1  2/12 (16.67%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness: Left-sided  1  1/12 (8.33%) 
Pain: Back  1  1/12 (8.33%) 
Pain: Joint  1  1/12 (8.33%) 
Pain: Muscle  1  2/12 (16.67%) 
Pain: Neck  1  1/12 (8.33%) 
Nervous system disorders   
Hemorrhage, CNS  1  1/12 (8.33%) 
Ataxia (incoordination)  1  1/12 (8.33%) 
Dizziness  1  1/12 (8.33%) 
Mood alteration  1  2/12 (16.67%) 
Neuropathy: motor  1  1/12 (8.33%) 
Seizure  1  2/12 (16.67%) 
Somnolence/depressed level of consciousness  1  8/12 (66.67%) 
Tremor  1  1/12 (8.33%) 
Pain: Head/headache  1  6/12 (50.00%) 
Renal and urinary disorders   
Hemorrhage, GU: Urinary NOS  1  1/12 (8.33%) 
Urinary frequency/urgency  1  4/12 (33.33%) 
Respiratory, thoracic and mediastinal disorders   
Pain: Chest/thorax NOS  1  1/12 (8.33%) 
Pain: Throat/pharynx/larynx  1  1/12 (8.33%) 
Cough  1  3/12 (25.00%) 
Pulmonary/Upper Respiratory - Other  1  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  1/12 (8.33%) 
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. Antineoplastons A10 and AS2-1 in the Treatment of Children with Optic Pathway Glioma: Final Report for BT-23. Cancer and Clinical Oncology 6(1): 25-35, 2017
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003477     History of Changes
Other Study ID Numbers: CDR0000066514
BC-BT-23 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: August 4, 2016
Results First Posted: December 16, 2016
Last Update Posted: August 24, 2017