This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Antineoplaston Therapy in Treating Patients With Brain Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Burzynski Research Institute
ClinicalTrials.gov Identifier:
NCT00003457
First received: November 1, 1999
Last updated: December 28, 2016
Last verified: December 2016
Results First Received: October 25, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Refractory Brain Tumors
Intervention: Drug: Antineoplaston therapy (Atengenal + Astugenal)

  Participant Flow
  Hide Participant Flow

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 July 1996 and March 2011. 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 persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).


Participant Flow:   Overall Study
    Antineoplaston Therapy
STARTED   40 
COMPLETED   31 
NOT COMPLETED   9 
Not evaluable                9 



  Baseline Characteristics
  Hide Baseline Characteristics

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 persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).


Baseline Measures
   Antineoplaston Therapy 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Median (Full Range)
 36.0 
 (18.1 to 64.2) 
Gender 
[Units: Participants]
Count of Participants
 
Female      18  45.0% 
Male      22  55.0% 


  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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 SR, Janicki TJ, Burzynski GS. A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Primary Brain Tumors—Final Report (Protocol BT-09). Journal of Cancer Therapy 6(12): 1063-1074, 2015. DOI: 10.4236/jct.2015.612116


Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003457     History of Changes
Other Study ID Numbers: CDR0000066489
BC-BT-9 ( Other Identifier: Burzynski Research Institute, Inc. )
Study First Received: November 1, 1999
Results First Received: October 25, 2016
Last Updated: December 28, 2016