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Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003456
First Posted: January 27, 2003
Last Update Posted: December 13, 2017
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.
Information provided by (Responsible Party):
Burzynski Research Institute
Results First Submitted: July 24, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Glioblastoma Multiforme of Brain
Intervention: Drug: Antineoplaston therapy (Atengenal + Astugenal)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Forty patients were recruited between March 1995 and June 2004. All study subjects were seen at the Burzynski Clinic in Houston TX

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Antineoplaston Therapy

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 a newly diagnosed Glioblastoma Multiforme 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.


Participant Flow:   Overall Study
    Antineoplaston Therapy
STARTED   40 
COMPLETED   32 
NOT COMPLETED   8 
Not evaluable                8 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Antineoplaston Therapy

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 a newly diagnosed Glioblastoma Multiforme 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.


Baseline Measures
   Antineoplaston Therapy 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Median (Full Range)
 52.4 
 (26.3 to 76.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  32.5% 
Male      27  67.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Objective Response   [ Time Frame: 12 months ]

2.  Secondary:   Percentage of Participants Who Survived   [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: srb@burzynskiclinic.com



Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003456     History of Changes
Other Study ID Numbers: CDR0000066488
BRI-BT-07 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: July 24, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017