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Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer

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ClinicalTrials.gov Identifier: NCT00003453
Recruitment Status : Terminated (Slow enrollment)
First Posted : January 27, 2003
Results First Posted : May 9, 2018
Last Update Posted : May 9, 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: Stage IV Adrenocortical Carcinoma
Intervention: Drug: Antineoplaston therapy (Atengenal + Astugenal)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Six patients were recruited between August 1996 and February 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 dose is reached.

Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Adrenal Gland Cancer 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   6 
COMPLETED   5 [1] 
NOT COMPLETED   1 
[1] One patient was not evaluable



  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): Patients with Stage IV Adrenal Gland Cancer 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]
 6 
Age 
[Units: Years]
Median (Full Range)
 45.0 
 (0.67 to 64.75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  50.0% 
Male      3  50.0% 


  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

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

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: NCT00003453     History of Changes
Other Study ID Numbers: CDR0000066485
BC-AD-02 ( Other Identifier: Burzynski Research Institute )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: March 11, 2018
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018