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Trial record 44 of 67 for:    Burzyński

Antineoplaston Therapy in Treating Patients With Ependymoma

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ClinicalTrials.gov Identifier: NCT00003479
Recruitment Status : Terminated (Slow accrual)
First Posted : January 27, 2003
Results First Posted : February 17, 2017
Last Update Posted : August 24, 2017
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 Ependymoma
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 9
Recruitment Details Nine patients were recruited between July 1996 and October 2000. 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 an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 9
Completed 6
Not Completed 3
Reason Not Completed
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): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
7.3
(1.6 to 35.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
5
  55.6%
Male
4
  44.4%
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; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
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): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
Partial Response 1
Stable Disease 2
Progressive Disease 3
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): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of Participants
6 months overall survival 66.7
12 months overall survival 44.4
24 months overall survival 33.3
36 months overall survival 22.2
48 months overall survival 22.2
60 months overall survival 11.1
Time Frame 4 years, 2 months
Adverse Event Reporting Description Nine patients were recruited between July 1996 and March 2000. All study subjects were seen at the Burzynski Clinic in Houston TX
 
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 an ependymoma 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   5/9 (55.56%) 
Blood and lymphatic system disorders   
Hemoglobin  1 [1]  1/9 (11.11%) 
Gastrointestinal disorders   
Pancreatitis  3 [2]  1/9 (11.11%) 
Pain: Stomach  3 [3]  1/9 (11.11%) 
Infections and infestations   
Central venous catheter infection  2 [4]  1/9 (11.11%) 
Infection (documented clinically): Blood  3 [5]  1/9 (11.11%) 
Investigations   
Hypokalemia  3 [6]  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Pain: Joint  3 [7]  1/9 (11.11%) 
Nervous system disorders   
Confusion  3 [8]  1/9 (11.11%) 
Seizure  3 [9]  1/9 (11.11%) 
Somnolence/depressed level of consciousness  3 [10]  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Rash: erythema multiforme  3 [11]  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (Version 3
2
Term from vocabulary, Institutional
3
Term from vocabulary, CTCAE (3.0)
[1]
The Hemoglobin was not related to Antineoplaston therapy.
[2]
The Pancreatitis was not related to Antineoplaston therapy.
[3]
The Pain: Stomach was not related to Antineoplaston therapy.
[4]
The Central venous catheter infection was not related to Antineoplaston therapy.
[5]
The Infection (documented clinically): Blood was not related to Antineoplaston therapy.
[6]
The Hypokalemia was possibly related to Antineoplaston therapy.
[7]
The Pain: Joint was possibly related to Antineoplaston therapy.
[8]
The Confusion was possibly related to Antineoplaston therapy.
[9]
The Seizure was not related to Antineoplaston therapy.
[10]
The Somnolence/depressed level of consciousness was not related to Antineoplaston therapy.
[11]
The Rash: erythema multiforme was possibly 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   9/9 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  5/9 (55.56%) 
Leukocytes (total WBC)  1  1/9 (11.11%) 
Lymphopenia  1  1/9 (11.11%) 
Neutrophils/granulocytes (ANC/AGC)  1  1/9 (11.11%) 
Gastrointestinal disorders   
Diarrhea  1  3/9 (33.33%) 
Nausea  1  5/9 (55.56%) 
Vomiting  1  4/9 (44.44%) 
Pancreatitis  1  1/9 (11.11%) 
Pain: Dental/teeth/peridontal  1  1/9 (11.11%) 
Pain: Stomach  1  1/9 (11.11%) 
General disorders   
Non-functional central venous catheter  2  3/9 (33.33%) 
Fatigue (asthenia, lethargy, malaise)  1  4/9 (44.44%) 
Fever  1  2/9 (22.22%) 
Insomnia  1  1/9 (11.11%) 
Rigors/chills  1  1/9 (11.11%) 
Weight gain  1  1/9 (11.11%) 
Pruritus/itching  1  1/9 (11.11%) 
Edema/Fluid retention  2  1/9 (11.11%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  2/9 (22.22%) 
Infections and infestations   
Central venous catheter infection  2  3/9 (33.33%) 
Infection (documented clinically): Bladder (urinary)  1  2/9 (22.22%) 
Infection (documented clinically): Blood  1  1/9 (11.11%) 
Infection (documented clinically): Mucosa  1  3/9 (33.33%) 
Infection (documented clinically): Pharynx  1  1/9 (11.11%) 
Infection (documented clinically): Sinus  1  1/9 (11.11%) 
Infection (documented clinically): Soft tissue NOS  1  1/9 (11.11%) 
Infection (documented clinically): Urinary tract NOS  1  1/9 (11.11%) 
Middle ear (otitis media)  1  1/9 (11.11%) 
Skin  1  1/9 (11.11%) 
Upper airway  1  1/9 (11.11%) 
Investigations   
Hyperglycemia  1  2/9 (22.22%) 
Hypernatremia  1  3/9 (33.33%) 
Hyperuricemia  1  1/9 (11.11%) 
Hypocalcemia  1  1/9 (11.11%) 
Hypochloremia  1  1/9 (11.11%) 
Hypoglycemia  1  1/9 (11.11%) 
Hypokalemia  1  7/9 (77.78%) 
Metabolic/Laboratory - Other  1  1/9 (11.11%) 
Proteinuria  1  1/9 (11.11%) 
SGOT  1  1/9 (11.11%) 
SGPT  1  3/9 (33.33%) 
Musculoskeletal and connective tissue disorders   
Pain: Joint  1  3/9 (33.33%) 
Nervous system disorders   
Apnea  1  1/9 (11.11%) 
Ataxia (incoordination)  1  1/9 (11.11%) 
Confusion  1  3/9 (33.33%) 
Dizziness  1  2/9 (22.22%) 
Neuropathy: cranial: CN VIII Hearing and balance  1  1/9 (11.11%) 
Neuropathy: sensory  1  1/9 (11.11%) 
Seizure  1  3/9 (33.33%) 
Somnolence/depressed level of consciousness  1  5/9 (55.56%) 
Speech impairment  1  2/9 (22.22%) 
Syncope (fainting)  1  1/9 (11.11%) 
Pain: Head/headache  1  4/9 (44.44%) 
Renal and urinary disorders   
Hemorrhage, GU: Bladder  1  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Rash: erythema multiforme  1  1/9 (11.11%) 
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: NCT00003479     History of Changes
Other Study ID Numbers: CDR0000066516
BC-BT-24 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: December 28, 2016
Results First Posted: February 17, 2017
Last Update Posted: August 24, 2017