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Trial record 8 of 67 for:    Burzyński

Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma

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ClinicalTrials.gov Identifier: NCT00003535
Recruitment Status : Terminated (Slow accrual)
First Posted : January 27, 2003
Results First Posted : December 13, 2017
Last Update Posted : March 21, 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 High Grade Glioma
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 9
Recruitment Details Nine patients were recruited between April 1994 and August 1997. 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 recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 9
Completed 4
Not Completed 5
Reason Not Completed
Not evaluable             5
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 recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
9.7
(4.8 to 17.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
1
  11.1%
Male
8
  88.9%
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 recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
1
  25.0%
Partial Response
1
  25.0%
Progressive Disease
2
  50.0%
2.Secondary Outcome
Title Percentage of Participants Who Survived
Hide Description 6 months, 12 months, 24 months overall survival
Time Frame 6 months, 12 months, 24 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 recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of Participants
6 months overall survival 22.2
12 months overall survival 11.1
24 months overall survival 0.0
Time Frame 3 years, 9 months
Adverse Event Reporting Description Thirteen patients were recruited between April 1994 and August 1997. 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 recurrent/progressive high grade 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   7/9 (77.78%) 
Blood and lymphatic system disorders   
Platelets  1 [1]  1/9 (11.11%) 
Gastrointestinal disorders   
Dehydration  1 [2]  1/9 (11.11%) 
Vomiting  1 [3]  1/9 (11.11%) 
General disorders   
Central Venous Catheter: Infection  2 [4]  1/9 (11.11%) 
Infections and infestations   
Infection: Other  1 [5]  1/9 (11.11%) 
Infection (documented clinically): Lung (pneumonia)  1 [6]  1/9 (11.11%) 
Investigations   
Hypernatremia  1 [7]  1/9 (11.11%) 
Nervous system disorders   
Seizure  1 [8]  1/9 (11.11%) 
Somnolence/depressed level of consciousness  1 [9]  1/9 (11.11%) 
Pain: Head/headache  1 [10]  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1 [11]  1/9 (11.11%) 
Pleural effusion (non-malignant)  1 [12]  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, Institutional
[1]
The Platelets were not related to Antineoplaston Therapy.
[2]
The Dehydration was not related to Antineoplaston Therapy.
[3]
The Vomiting was not related to Antineoplaston Therapy.
[4]
The Central Venous Catheter: Infection was not related to Antineoplaston Therapy.
[5]
The Infection: Other was not related to Antineoplaston Therapy
[6]
The Infection (documented clinically): Lung (pneumonia) was not related to Antineoplaston Therapy.
[7]
The Hypernatremia was related to Antineoplaston Therapy
[8]
The Seizure was related to Antineoplaston Therapy.
[9]
The Somnolence/depressed level of consciousness was not related to Antineoplaston Therapy.
[10]
The Pain: Head/headache was not related to Antineoplaston therapy
[11]
The Dyspnea (shortness of breath) was not related to Antineoplaston Therapy.
[12]
The Pleural effusion (non-malignant) 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   9/9 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  1/9 (11.11%) 
Leukocytes (total WBC)  1  1/9 (11.11%) 
Lymphopenia  1  1/9 (11.11%) 
Neutrophils/granulocytes (ANC/AGC)  1  2/9 (22.22%) 
Platelets  1  3/9 (33.33%) 
Cardiac disorders   
Supraventricular and nodal arrhythmia: Sinus tachycardia  1 [1]  1/9 (11.11%) 
Hypertension  1  1/9 (11.11%) 
Gastrointestinal disorders   
Dehydration  1  1/9 (11.11%) 
Diarrhea  1  2/9 (22.22%) 
Nausea  1  2/9 (22.22%) 
Vomiting  1  4/9 (44.44%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  3/9 (33.33%) 
Fever  1  1/9 (11.11%) 
Edema/Fluid retention  2  1/9 (11.11%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  1/9 (11.11%) 
Infections and infestations   
Central Venous Catheter: Infection  2  1/9 (11.11%) 
Infection: Other  1  1/9 (11.11%) 
Infection (documented clinically): Lung (pneumonia)  1  2/9 (22.22%) 
Infection (documented clinically): Mucosa  1  2/9 (22.22%) 
Infection (documented clinically): Upper airway NOS  1  1/9 (11.11%) 
Investigations   
Hypercholesteremia  1  1/9 (11.11%) 
Hyperglycemia  1  2/9 (22.22%) 
Hypokalemia  1  8/9 (88.89%) 
Hypomagnesemia  1  1/9 (11.11%) 
Hypophosphatemia  1  1/9 (11.11%) 
Proteinuria  1  1/9 (11.11%) 
Hypernatremia  1  5/9 (55.56%) 
Nervous system disorders   
Confusion  1  2/9 (22.22%) 
Seizure  1  1/9 (11.11%) 
Somnolence/depressed level of consciousness  1  4/9 (44.44%) 
Speech impairment  1  2/9 (22.22%) 
Pain: Head/headache  1  1/9 (11.11%) 
Renal and urinary disorders   
Hemorrhage, GU: Bladder  1  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  3/9 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, Institutional
[1]
Supraventricular and nodal arrhythmia: Sinus tachycardia
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
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003535     History of Changes
Other Study ID Numbers: CDR0000066582
BC-BT-06 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: August 1, 2017
Results First Posted: December 13, 2017
Last Update Posted: March 21, 2018