Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 54 of 67 for:    Burzyński

Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma

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: NCT00003468
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : November 10, 2016
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 Low Grade Astrocytomas
Intervention Drug: Antineoplaston therapy (Atengenal + Astugenal)
Enrollment 11
Recruitment Details Eleven patients were recruited between July 1996 and November 2005. 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.

Children with a low-grade astrocytoma who have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

Period Title: Overall Study
Started 11
Completed 9 [1]
Not Completed 2
[1]
Two patients were 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): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
9.3
(3.7 to 17.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
2
  18.2%
Male
9
  81.8%
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): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Participants
Complete Response 4
Partial Response 1
Stable Disease 4
Progressive Disease 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
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): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Percentage of participants
6 months overall survival 81.8
12 months overall survival 81.8
24 months overall survival 63.6
36 months overall survival 63.6
48 months overall survival 63.6
60 months overall survival 63.6
Time Frame 9 years, 6 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): Children with a low grade astrocytoma that have not responded to standard therapy 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   6/11 (54.55%) 
Gastrointestinal disorders   
Pain: Abdomen NOS  2 [1]  1/11 (9.09%) 
General disorders   
Fever  2 [2]  1/11 (9.09%) 
Infections and infestations   
Central venous catheter infection  1 [3]  1/11 (9.09%) 
Chicken pox  2 [4]  1/11 (9.09%) 
Investigations   
Hypernatremia  2 [5]  1/11 (9.09%) 
Nervous system disorders   
Seizure  2 [6]  4/11 (36.36%) 
Renal and urinary disorders   
Renal/Genitourinary-Other: kidney stones  2 [7]  1/11 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Institutional
2
Term from vocabulary, CTCAE (3.0)
[1]
The Pain: Abdomen NOS 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 chicken pox was not related to Antineoplaston therapy.
[5]
The Hypernatremia was not related to Antineoplaston therapy.
[6]
The Seizures were not related to Antineoplaston therapy.
[7]
The Renal/Genitourinary-Other: kidney stones were 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   11/11 (100.00%) 
Blood and lymphatic system disorders   
Blood/Bone Marrow - Other  1  1/11 (9.09%) 
Hemoglobin  1  5/11 (45.45%) 
Leukocytes (total WBC)  1  4/11 (36.36%) 
Lymphopenia  1  8/11 (72.73%) 
Neutrophils/granulocytes (ANC/AGC)  1  4/11 (36.36%) 
Platelets  1  1/11 (9.09%) 
PTT (Partial Thromboplastin Time)  1  1/11 (9.09%) 
Pain: Lymph node  1  1/11 (9.09%) 
Cardiac disorders   
Supraventricular and nodal arrhythmia: Sinus bradycardia  1  1/11 (9.09%) 
Supraventricular and nodal arrhythmia: Sinus tachycardia  1  2/11 (18.18%) 
Endocrine disorders   
Cushingoid  1  1/11 (9.09%) 
Cushingoid appearance  1  4/11 (36.36%) 
Endocrine - Other  1  1/11 (9.09%) 
Hot flashes/flushes  1  3/11 (27.27%) 
Eye disorders   
Vision-blurred vision  1  2/11 (18.18%) 
Vision-flashing lights/floaters  1  1/11 (9.09%) 
Vision-photophobia  1  1/11 (9.09%) 
Gastrointestinal disorders   
Anorexia  1  2/11 (18.18%) 
Ascites (non-malignant)  1  1/11 (9.09%) 
Constipation  1  4/11 (36.36%) 
Dehydration  1  2/11 (18.18%) 
Diarrhea  1  8/11 (72.73%) 
Distension/bloating, abdominal  1  2/11 (18.18%) 
Dry mouth/salivary gland (xerostomia)  1  6/11 (54.55%) 
Dysphagia (difficulty swallowing)  1  1/11 (9.09%) 
Gastrointestinal - Other  1  1/11 (9.09%) 
Heartburn/dyspepsia  1  1/11 (9.09%) 
Nausea  1  8/11 (72.73%) 
Vomiting  1  8/11 (72.73%) 
Pain: Abdomen NOS  1  3/11 (27.27%) 
General disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  4/11 (36.36%) 
Allergic rhinitis (including sneezing, nasal stuffiness, 2 2  1  2/11 (18.18%) 
Non-functional central venous cateter  2  4/11 (36.36%) 
Pain : Central venous catheter  2  1/11 (9.09%) 
Central venous catheter: Thrombosis/embolism  2  1/11 (9.09%) 
Constitutional Symptoms - Other  1  1/11 (9.09%) 
Fatigue (asthenia, lethargy, malaise)  1  8/11 (72.73%) 
Fever  1  5/11 (45.45%) 
Obesity  1  1/11 (9.09%) 
Rigors/chills  1  3/11 (27.27%) 
Weight gain  1  5/11 (45.45%) 
Weight loss  1  1/11 (9.09%) 
Edema/Fluid retention  2  8/11 (72.73%) 
Infections and infestations   
Central venous catheter infection  2  5/11 (45.45%) 
Chicken pox  1  1/11 (9.09%) 
Infection - Other  1  4/11 (36.36%) 
Infection (documented clinically): Lung (pneumonia)  1  1/11 (9.09%) 
Infection (documented clinically): Middle ear (otitis)  1  2/11 (18.18%) 
Infection (documented clinically): Blood  1  1/11 (9.09%) 
Infection (documented clinically): Pharynx  1  2/11 (18.18%) 
Infection (documented clinically): Sinus  1  2/11 (18.18%) 
Infection (documented clinically): Upper airway NOS  1  1/11 (9.09%) 
Opportunistic infection  1  1/11 (9.09%) 
Investigations   
Albumin, serum-low (hypoalbuminemia)  1  2/11 (18.18%) 
Alkaline phosphatase  1  2/11 (18.18%) 
Bicarbonate, serum-low  1  3/11 (27.27%) 
Hypercholesterolemia  1  6/11 (54.55%) 
Hyperglycemia  1  8/11 (72.73%) 
Hyperkalemia  1  2/11 (18.18%) 
Hypernatremia  1  9/11 (81.82%) 
Hypertriglyceridemia  1  2/11 (18.18%) 
Hyperuricemia  1  1/11 (9.09%) 
Hypocalcemia  1  3/11 (27.27%) 
Hypoglycemia  1  1/11 (9.09%) 
Hypokalemia  1  9/11 (81.82%) 
Hypomagnesemia  1  3/11 (27.27%) 
Hyponatremia  1  3/11 (27.27%) 
Hypophosphatemia  1  3/11 (27.27%) 
Metabolic/Laboratory - Other  1  5/11 (45.45%) 
Proteinuria  1  4/11 (36.36%) 
SGOT  1  5/11 (45.45%) 
SGPT  1  6/11 (54.55%) 
Uric acid, serum-high (hyperuricemia)  1  3/11 (27.27%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness: Extremity-lower  1  1/11 (9.09%) 
Muscle weakness: Whole body/generalized  1  2/11 (18.18%) 
Musculoskeletal/Soft Tissue - Other  1  2/11 (18.18%) 
Musculoskeletal-Other  1  1/11 (9.09%) 
Pain: Back  1  4/11 (36.36%) 
Pain: Buttock  1  1/11 (9.09%) 
Pain: Chest/thorax NOS  1  2/11 (18.18%) 
Pain: Extremity-limb  1  2/11 (18.18%) 
Pain: Joint  1  5/11 (45.45%) 
Pain: Muscle  1  2/11 (18.18%) 
Pain: Neck  1  3/11 (27.27%) 
Nervous system disorders   
Ataxia (incoordination)  1  3/11 (27.27%) 
Confusion  1  2/11 (18.18%) 
Dizziness  1  7/11 (63.64%) 
Memory impairment  1  1/11 (9.09%) 
Mood alteration: Agitation  1  1/11 (9.09%) 
Mood alteration: Depression  1  1/11 (9.09%) 
Neurology - Other  1  2/11 (18.18%) 
Neuropathy - cranial  1  1/11 (9.09%) 
Neuropathy: CN III Pupil, upper eyelid, extra ocular movements  1  2/11 (18.18%) 
Neuropathy: sensory  1  1/11 (9.09%) 
Seizure  1  4/11 (36.36%) 
Somnolence/depressed level of consciousness  1  7/11 (63.64%) 
Speech impairment  1  2/11 (18.18%) 
Syncope (fainting)  1  2/11 (18.18%) 
Tremor  1  3/11 (27.27%) 
Pain: Head/headache  1  7/11 (63.64%) 
Renal and urinary disorders   
Hemorrhage, GU: Urinary NOS  1  3/11 (27.27%) 
Pain: Urethra  1  1/11 (9.09%) 
Renal/Genitourinary-Other: kidney stones  1  1/11 (9.09%) 
Renal/Genitourinary-Other  1  1/11 (9.09%) 
Urinary frequency/urgency  1  7/11 (63.64%) 
Respiratory, thoracic and mediastinal disorders   
Pain: Throat/pharynx/larynx  1  1/11 (9.09%) 
Cough  1  1/11 (9.09%) 
Dyspnea (shortness of breath)  1  2/11 (18.18%) 
Hiccoughs (hiccups, singultus)  1  1/11 (9.09%) 
Pulmonary/Upper Respiratory - Other  1  2/11 (18.18%) 
Skin and subcutaneous tissue disorders   
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  2/11 (18.18%) 
Dermatology/Skin - Other  1  2/11 (18.18%) 
Flushing  1  1/11 (9.09%) 
Petechiae  1  1/11 (9.09%) 
Pruritus/itching  1  2/11 (18.18%) 
Rash/desquamation  1  2/11 (18.18%) 
Rash: acne/acneiform  1  2/11 (18.18%) 
Striae  1  1/11 (9.09%) 
Pain: Scalp  1  1/11 (9.09%) 
Vascular disorders   
Vascular - Other  1  1/11 (9.09%) 
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
Publications:
Burzynski, SR, Janicki, TJ, Burzynski, G.S. A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Low-Grade Astrocytomas—Final Report (Protocol BT-13). Submitted to Journal of Cancer Therapy, 2016
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003468     History of Changes
Other Study ID Numbers: CDR0000066504
BC-BT-13 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: September 22, 2016
Results First Posted: November 10, 2016
Last Update Posted: August 24, 2017