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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)
Enrollment 6
Recruitment Details 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  
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): 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.

Period Title: Overall Study
Started 6
Completed 5 [1]
Not Completed 1
[1]
One patient was not evaluable
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): 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.

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
45.0
(0.67 to 64.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
3
  50.0%
Male
3
  50.0%
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
Show Outcome Measure DataHide 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): 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.

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
1
  20.0%
Partial Response
1
  20.0%
Stable Disease
1
  20.0%
Progressive Disease
2
  40.0%
2.Secondary Outcome
Title Percentage of Participants Who Survived
Hide Description 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
Time Frame 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Show Outcome Measure DataHide 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): 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.

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Percentage of participants
6 months overall survival 83.3
12 months overall survival 66.7
24 months overall survival 50.0
36 months overall survival 33.3
48 months overall survival 33.3
60 months overaall survival 33.3
Time Frame 13 years, 5 months
Adverse Event Reporting Description Adverse event data was collected through regular patient assessment and regular laboratory testing
 
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): 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.

All-Cause Mortality
Antineoplaston Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Antineoplaston Therapy
Affected / at Risk (%)
Total   4/6 (66.67%) 
Gastrointestinal disorders   
Ascites (non-malignant)  1 [1]  1/6 (16.67%) 
General disorders   
Fever  1 [2]  1/6 (16.67%) 
Central Venous Catheter Infection  2 [3]  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue - Other (Muscle Spasms)  1 [4]  1/6 (16.67%) 
Nervous system disorders   
Somnolence/depressed level of consciousness  1 [5]  1/6 (16.67%) 
Dizziness  1 [6]  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, Institutional
[1]
The Ascites (non-malignant) was not related to Antineoplaston Therapy
[2]
The Fever was not related to Antineoplaston Therapy.
[3]
The Central Venous Catheter Infection was not related to Antineoplaston Therapy
[4]
The Musculoskeletal/Soft Tissue - Other (Muscle Spasms) was not related to Antineoplaston Therapy
[5]
The Somnolence/depressed level of consciousness was not related to Antineoplaston Therapy
[6]
The Dizziness 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   6/6 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  4/6 (66.67%) 
Leukocytes (total WBC)  1  2/6 (33.33%) 
Lymphopenia  1  2/6 (33.33%) 
Neutrophils/granulocytes (ANC/AGC)  1  2/6 (33.33%) 
Platelets  1  2/6 (33.33%) 
Cardiac disorders   
Cardiac Arrhythmia - Other  1  2/6 (33.33%) 
Hypertension  1  3/6 (50.00%) 
Gastrointestinal disorders   
Anorexia  1  1/6 (16.67%) 
Ascites (non-malignant)  1  1/6 (16.67%) 
Constipation  1  2/6 (33.33%) 
Dental: teeth  1  1/6 (16.67%) 
Diarrhea  1  1/6 (16.67%) 
Dry mouth/salivary gland (xerostomia)  1  2/6 (33.33%) 
Enteritis (inflammation of the small bowel)  1  1/6 (16.67%) 
Nausea  1  5/6 (83.33%) 
Vomiting  1  4/6 (66.67%) 
Pain: Abdomen NOS  1  4/6 (66.67%) 
General disorders   
Central venous catheter infection  2  2/6 (33.33%) 
Non-functional central venous catheter  2  2/6 (33.33%) 
Central venous catheter - Other  2  2/6 (33.33%) 
Pain: Central venous catheter  2  1/6 (16.67%) 
Fatigue (asthenia, lethargy, malaise)  1  5/6 (83.33%) 
Fever  1  3/6 (50.00%) 
Insomnia  1  1/6 (16.67%) 
Rigors/chills  1  2/6 (33.33%) 
Sweating (diaphoresis)  1  1/6 (16.67%) 
Edema/Fluid retention  2  2/6 (33.33%) 
Flu-like syndrome  1  1/6 (16.67%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  1/6 (16.67%) 
Allergic rhinitis (including sneezing, nasal stuffiness  1  1/6 (16.67%) 
Infections and infestations   
Infection - Other  1  1/6 (16.67%) 
Infection (documented clinically): Bladder (urinary)  1  1/6 (16.67%) 
Infection (documented clinically): Bronchus  1  1/6 (16.67%) 
Infection (documented clinically): Dental-tooth  1  1/6 (16.67%) 
Infection (documented clinically): Mucosa  1  1/6 (16.67%) 
Infection (documented clinically): Upper airway NOS  1  1/6 (16.67%) 
Infection with normal ANC: Abdomen NOS  1  1/6 (16.67%) 
Investigations   
Albumin, serum-low (hypoalbuminemia)  1  3/6 (50.00%) 
Alkaline phosphatase  1  4/6 (66.67%) 
Bicarbonate, serum-low  1  2/6 (33.33%) 
Hypercalcemia  1  1/6 (16.67%) 
Hypercholesteremia  1  2/6 (33.33%) 
Hyperglycemia  1  1/6 (16.67%) 
Hyperkalemia  1  1/6 (16.67%) 
Hypernatremia  1  3/6 (50.00%) 
Hypertriglyceridemia  1  2/6 (33.33%) 
Hypocalcemia  1  3/6 (50.00%) 
Hypoglycemia  1  4/6 (66.67%) 
Hypokalemia  1  6/6 (100.00%) 
Hypomagnesemia  1  1/6 (16.67%) 
Hypophosphatemia  1  2/6 (33.33%) 
Proteinuria  1  2/6 (33.33%) 
SGOT  1  3/6 (50.00%) 
SGPT  1  1/6 (16.67%) 
Uric acid, serum-high (hyperuricemia)  1  2/6 (33.33%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue - Other (Muscle Spasms)  1  1/6 (16.67%) 
Pain: Chest/thorax NOS  1  1/6 (16.67%) 
Pain: Joint  1  1/6 (16.67%) 
Pain: Muscle  1  2/6 (33.33%) 
Pain: Neck  1  1/6 (16.67%) 
Nervous system disorders   
Confusion  1  1/6 (16.67%) 
Dizziness  1  2/6 (33.33%) 
Mood alteration  1  1/6 (16.67%) 
Mood alteration: Agitation  1  1/6 (16.67%) 
Somnolence/depressed level of consciousness  1  3/6 (50.00%) 
Pain: Head/headache  1  3/6 (50.00%) 
Renal and urinary disorders   
Hemorrhage, GU: Bladder  1  2/6 (33.33%) 
Pain: Bladder  1  1/6 (16.67%) 
Renal/Genitourinary - Other  1  1/6 (16.67%) 
Urinary frequency/urgency  1  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Pain: Throat/pharynx/larynx  1  1/6 (16.67%) 
Cough  1  1/6 (16.67%) 
Dyspnea (shortness of breath)  1  2/6 (33.33%) 
Hypoxia  1  1/6 (16.67%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  1/6 (16.67%) 
Pruritus/itching  1  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, Institutional
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: 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