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Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas

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.
ClinicalTrials.gov Identifier: NCT00003473
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : November 1, 2016
Last Update Posted : January 17, 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 Mixed Gliomas
Interventions Drug: Atengenal
Drug: Astugenal
Enrollment 20
Recruitment Details Twenty patients were recruited between March 1996 and May 2008. 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, to mitigate adverse reactions to treatment, until the maximum tolerated dose is reached.

Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 20
Completed 17
Not Completed 3
Reason Not Completed
Three patients were not evaluable.             3
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): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
37.3
(26.7 to 54.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
6
  30.0%
Male
14
  70.0%
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
Hide 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): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: Participants
Complete Response 3
Partial Response 0
Stable Disease 4
Progressive Disease 10
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
Hide Outcome Measure Data
Hide Analysis Population Description
All study subjects receiving any Antineoplaston therapy
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): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Percentage of participants
6 months overall survival 65.0
12 months overall survival 55.0
24 months overall survival 30.0
36 months overall survival 30.0
48 months overall survival 20.0
60 months overall survival 15.0
Time Frame 10 years, 4 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): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

All-Cause Mortality
Antineoplaston Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Antineoplaston Therapy
Affected / at Risk (%)
Total   8/20 (40.00%) 
Blood and lymphatic system disorders   
Thrombosis/thrombus/embolism  2 [1]  1/20 (5.00%) 
General disorders   
Non-functional central venous catheter  1 [2]  1/20 (5.00%) 
Infections and infestations   
Central venous catheter infection  1 [3]  1/20 (5.00%) 
Nervous system disorders   
Seizure  2 [4]  2/20 (10.00%) 
Somnolence/depressed level of consciousness  2 [5]  3/20 (15.00%) 
Pain: Head/headache  2 [6]  3/20 (15.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Institutional
2
Term from vocabulary, CTCAE (3)
[1]
The thrombosis/thrombus/embolism was not related to Antineoplaston therapy.
[2]
The non-functional venous catheter was not related to Antineoplaston therapy.
[3]
The central venous catheter infection was not related to Antineoplaton therapy.
[4]
Neither of the seizures were related to Antineoplaston therapy.
[5]
none of the somnolences/depressed levels of consciousness were related to Antineoplaston therapy.
[6]
None of the pain: head/headaches were due 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   20/20 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  5/20 (25.00%) 
Leukocytes (total WBC)  1  4/20 (20.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  2/20 (10.00%) 
Platelets  1  4/20 (20.00%) 
INR (International Normalized Ratio of prothrombin time)  1  1/20 (5.00%) 
Cardiac disorders   
Palpitations  1  1/20 (5.00%) 
Hypertension  1  2/20 (10.00%) 
Ear and labyrinth disorders   
Auditory/Ear - Other  1  1/20 (5.00%) 
Hearing (without monitoring program)  1  2/20 (10.00%) 
Tinnitus  1  1/20 (5.00%) 
Endocrine disorders   
Cushingoid appearance  1  1/20 (5.00%) 
Hot flashes/flushes  1  1/20 (5.00%) 
Eye disorders   
Diplopia  1  1/20 (5.00%) 
Ophthalmoplegia/diplopia (double vision)  1  1/20 (5.00%) 
Vision-blurred vision  1  1/20 (5.00%) 
Vision-photophobia  1  2/20 (10.00%) 
Gastrointestinal disorders   
Anorexia  1  1/20 (5.00%) 
Constipation  1  1/20 (5.00%) 
Diarrhea  1  3/20 (15.00%) 
Dry mouth/salivary gland (xerostomia)  1  1/20 (5.00%) 
Dysphagia (difficulty swallowing)  1  2/20 (10.00%) 
Gastrointestinal - Other  1  1/20 (5.00%) 
Heartburn/dyspepsia  1  2/20 (10.00%) 
Nausea  1  9/20 (45.00%) 
Taste alteration (dysgeusia)  1  3/20 (15.00%) 
Vomiting  1  9/20 (45.00%) 
Hemorrhage, GI: Upper GI NOS  1  1/20 (5.00%) 
Pain: Abdomen NOS  1  1/20 (5.00%) 
General disorders   
Central Venous Catheter Non-functional  2  6/20 (30.00%) 
Central Venous Catheter Thrombosis/embolism  2  1/20 (5.00%) 
Fatigue (asthenia, lethargy, malaise)  1  13/20 (65.00%) 
Fever  1  5/20 (25.00%) 
Insomnia  1  1/20 (5.00%) 
Rigors/chills  1  3/20 (15.00%) 
Edema/Fluid retention  2  7/20 (35.00%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  4/20 (20.00%) 
Allergy/Immunology - Other  1  1/20 (5.00%) 
Infections and infestations   
Central Venous Catheter Infection  2  1/20 (5.00%) 
Infection (documented clinically): Bladder (urinary)  1  1/20 (5.00%) 
Infection (documented clinically): Lung (pneumonia)  1  1/20 (5.00%) 
Infection: Mucosa  1  1/20 (5.00%) 
Infection: Other  1  1/20 (5.00%) 
Infection: Stomach  1  1/20 (5.00%) 
Infection: Upper airway  1  1/20 (5.00%) 
Investigations   
Albumin, serum-low (hypoalbuminemia)  1  1/20 (5.00%) 
Alkaline phosphatase  1  1/20 (5.00%) 
GGT (gamma-Glutamyl transpeptidase)  1  2/20 (10.00%) 
Hypercholesteremia  1  3/20 (15.00%) 
Hyperglycemia  1  3/20 (15.00%) 
Hypernatremia  1  15/20 (75.00%) 
Hypertriglyceridemia  1  2/20 (10.00%) 
Hypocalcemia  1  1/20 (5.00%) 
Hypoglycemia  1  6/20 (30.00%) 
Hypokalemia  1  16/20 (80.00%) 
Hypomagnesemia  1  1/20 (5.00%) 
Hypophosphatemia  1  5/20 (25.00%) 
Metabolic/Laboratory - Other  1  3/20 (15.00%) 
Proteinuria  1  2/20 (10.00%) 
SGOT  1  2/20 (10.00%) 
SGPT  1  4/20 (20.00%) 
Uric acid, serum-high (hyperuricemia)  1  2/20 (10.00%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness: Whole body/generalized  1  2/20 (10.00%) 
Musculoskeletal/Soft Tissue - Other  1  1/20 (5.00%) 
Musculoskeletal-Other  1  1/20 (5.00%) 
Pain: Back  1  1/20 (5.00%) 
Pain: Joint  1  4/20 (20.00%) 
Pain: Muscle  1  3/20 (15.00%) 
Pain-Other  1  1/20 (5.00%) 
Nervous system disorders   
Ataxia (incoordination)  1  5/20 (25.00%) 
Confusion  1  7/20 (35.00%) 
Dizziness  1  9/20 (45.00%) 
Memory impairment  1  2/20 (10.00%) 
Mood alteration  1  3/20 (15.00%) 
Mood alteration: Agitation  1  1/20 (5.00%) 
Neuropathy - cranial  1  1/20 (5.00%) 
Neuropathy - motor  1  3/20 (15.00%) 
Neuropathy: CN III Pupil, upper eyelid, extra ocular movements  1  1/20 (5.00%) 
Neuropathy: sensory  1  2/20 (10.00%) 
Psychosis (hallucinations/delusions)  1  3/20 (15.00%) 
Seizure  1  6/20 (30.00%) 
Somnolence/depressed level of consciousness  1  11/20 (55.00%) 
Speech impairment  1  7/20 (35.00%) 
Tremor  1  3/20 (15.00%) 
Pain: Head/headache  1  11/20 (55.00%) 
Renal and urinary disorders   
Hemorrhage, GU  1  1/20 (5.00%) 
Hemorrhage, GU: Bladder  1  3/20 (15.00%) 
Hemorrhage, GU: Urinary NOS  1  1/20 (5.00%) 
Urinary frequency/urgency  1  5/20 (25.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  4/20 (20.00%) 
Thrombosis/thrombus/embolism  1  2/20 (10.00%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/20 (5.00%) 
Dermatology/Skin - Other  1  1/20 (5.00%) 
Pruritus/itching  1  1/20 (5.00%) 
Rash/desquamation  1  1/20 (5.00%) 
Vascular disorders   
Phlebitis (including superficial thrombosis)  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3)
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: NCT00003473     History of Changes
Other Study ID Numbers: CDR0000066510
BC-BT-18 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: August 24, 2016
Results First Posted: November 1, 2016
Last Update Posted: January 17, 2018