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Antineoplaston Therapy in Treating Patients With Brain Stem Glioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Burzynski Research Institute
ClinicalTrials.gov Identifier:
NCT00003459
First received: November 1, 1999
Last updated: August 18, 2016
Last verified: August 2016
Results First Received: May 25, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Brain Stem Gliomas
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
Fourty patients were recruited between March 1996 and January 2007. 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 dosage is reached.

Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)


Participant Flow:   Overall Study
    Antineoplaston Therapy
STARTED   40 
COMPLETED   31 [1] 
NOT COMPLETED   9 
[1] Nine patients were not evaluable.



  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 dosage is reached.

Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)


Baseline Measures
   Antineoplaston Therapy 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Median (Full Range)
 11.2 
 (3.5 to 43.8) 
Gender 
[Units: Participants]
 
Female   18 
Male   22 


  Outcome Measures
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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


Publications:
Burzynski, S.R., Janicki, J., Burzynski, G., Marszalek, A. A Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Brainstem Gliomas. The Report on Non-Diffuse Intrinsic Pontine Glioma (Protocol BT-11). Journal of Cancer Therapy, 6: 334-344, 2015


Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003459     History of Changes
Other Study ID Numbers: CDR0000066491
BC-BT-11 ( Other Identifier: Burzynski Research Institute, Inc )
Study First Received: November 1, 1999
Results First Received: May 25, 2016
Last Updated: August 18, 2016
Health Authority: United States: Food and Drug Administration