Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma (NCT NCT00003471)
NCT ID: NCT00003471
Last Updated: 2018-03-22
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
12 months
Results posted on
2018-03-22
Participant Flow
Seven patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Participant milestones
| Measure |
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): Adults with a recurrent/progressive low grade astrocytoma 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.
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|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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): Adults with a recurrent/progressive low grade astrocytoma 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.
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|---|---|
|
Overall Study
Not evaluable
|
4
|
Baseline Characteristics
Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma
Baseline characteristics by cohort
| Measure |
Antineoplaston Therapy
n=7 Participants
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/progressive low grade astrocytoma 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.
|
|---|---|
|
Age, Continuous
|
43.1 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsObjective 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.
Outcome measures
| Measure |
Antineoplaston Therapy
n=3 Participants
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/progressive low grade astrocytoma 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.
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|---|---|
|
Number of Participants With Objective Response
Stable Disease
|
2 Participants
|
|
Number of Participants With Objective Response
Progressive Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
Outcome measures
| Measure |
Antineoplaston Therapy
n=7 Participants
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/progressive low grade astrocytoma 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.
|
|---|---|
|
Percentage of Participants Who Survived
6 months overall survival
|
71.4 Percentage of participants
|
|
Percentage of Participants Who Survived
12 months overall survival
|
57.1 Percentage of participants
|
|
Percentage of Participants Who Survived
24 months overall survival
|
42.9 Percentage of participants
|
|
Percentage of Participants Who Survived
36 months overall survival
|
42.9 Percentage of participants
|
|
Percentage of Participants Who Survived
48 months overall survival
|
28.6 Percentage of participants
|
|
Percentage of Participants Who Survived
60 months overall survival
|
28.6 Percentage of participants
|
Adverse Events
Antineoplaston Therapy
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antineoplaston Therapy
n=7 participants at risk
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/progressive low grade astrocytoma 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.
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|---|---|
|
General disorders
Central Venous Catheter: Non-functional
|
14.3%
1/7 • 7 years, 4 months
|
|
General disorders
Central Venous Catheter: Thrombosis/embolism
|
14.3%
1/7 • 7 years, 4 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
14.3%
1/7 • 7 years, 4 months
|
|
Infections and infestations
Infection (documented clinically): Lung (pneumonia)
|
14.3%
1/7 • 7 years, 4 months
|
|
Investigations
Hypernatremia
|
28.6%
2/7 • 7 years, 4 months
|
|
Nervous system disorders
Seizure
|
14.3%
1/7 • 7 years, 4 months
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
14.3%
1/7 • 7 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
14.3%
1/7 • 7 years, 4 months
|
Other adverse events
| Measure |
Antineoplaston Therapy
n=7 participants at risk
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/progressive low grade astrocytoma 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.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
28.6%
2/7 • 7 years, 4 months
|
|
Ear and labyrinth disorders
Tinnitus
|
14.3%
1/7 • 7 years, 4 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
14.3%
1/7 • 7 years, 4 months
|
|
Blood and lymphatic system disorders
Platelets
|
14.3%
1/7 • 7 years, 4 months
|
|
Cardiac disorders
Hypertension
|
14.3%
1/7 • 7 years, 4 months
|
|
General disorders
Central Venous Catheter: Non-functional
|
42.9%
3/7 • 7 years, 4 months
|
|
General disorders
Central Venous Catheter: Thrombosis/embolism
|
14.3%
1/7 • 7 years, 4 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
42.9%
3/7 • 7 years, 4 months
|
|
General disorders
Insomnia
|
14.3%
1/7 • 7 years, 4 months
|
|
General disorders
Edema/Fluid retention
|
28.6%
2/7 • 7 years, 4 months
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • 7 years, 4 months
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • 7 years, 4 months
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • 7 years, 4 months
|
|
Infections and infestations
Infection (documented clinically): Lung (pneumonia)
|
14.3%
1/7 • 7 years, 4 months
|
|
Infections and infestations
Infection (documented clinically): Skin (cellulitis)
|
14.3%
1/7 • 7 years, 4 months
|
|
Infections and infestations
Infection (documented clinically): Upper airway NOS
|
14.3%
1/7 • 7 years, 4 months
|
|
Infections and infestations
Infection (documented clinically): Urinary tract NOS
|
14.3%
1/7 • 7 years, 4 months
|
|
Infections and infestations
Opportunistic infection
|
28.6%
2/7 • 7 years, 4 months
|
|
Investigations
GGT (gamma-Glutamyl transpeptidase)
|
14.3%
1/7 • 7 years, 4 months
|
|
Investigations
Hypercholesteremia
|
14.3%
1/7 • 7 years, 4 months
|
|
Investigations
Hyperglycemia
|
42.9%
3/7 • 7 years, 4 months
|
|
Investigations
Hypernatremia
|
28.6%
2/7 • 7 years, 4 months
|
|
Investigations
Hypertriglyceridemia
|
14.3%
1/7 • 7 years, 4 months
|
|
Investigations
Hypocalcemia
|
14.3%
1/7 • 7 years, 4 months
|
|
Investigations
Hypoglycemia
|
28.6%
2/7 • 7 years, 4 months
|
|
Investigations
Hypokalemia
|
85.7%
6/7 • 7 years, 4 months
|
|
Investigations
Hypophosphatemia
|
14.3%
1/7 • 7 years, 4 months
|
|
Investigations
Proteinuria
|
14.3%
1/7 • 7 years, 4 months
|
|
Investigations
SGOT
|
14.3%
1/7 • 7 years, 4 months
|
|
Investigations
SGPT
|
14.3%
1/7 • 7 years, 4 months
|
|
Nervous system disorders
Confusion
|
28.6%
2/7 • 7 years, 4 months
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • 7 years, 4 months
|
|
Nervous system disorders
Mood alteration
|
14.3%
1/7 • 7 years, 4 months
|
|
Nervous system disorders
Neuropathy: sensory
|
14.3%
1/7 • 7 years, 4 months
|
|
Nervous system disorders
Seizure
|
42.9%
3/7 • 7 years, 4 months
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
42.9%
3/7 • 7 years, 4 months
|
|
Nervous system disorders
Speech impairment
|
14.3%
1/7 • 7 years, 4 months
|
|
Eye disorders
Vision-blurred vision
|
14.3%
1/7 • 7 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
14.3%
1/7 • 7 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Chest wall
|
14.3%
1/7 • 7 years, 4 months
|
|
Nervous system disorders
Pain: Head/headache
|
28.6%
2/7 • 7 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Neck
|
14.3%
1/7 • 7 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain: Pleura
|
14.3%
1/7 • 7 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
14.3%
1/7 • 7 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
14.3%
1/7 • 7 years, 4 months
|
|
Renal and urinary disorders
Incontinence, urinary
|
14.3%
1/7 • 7 years, 4 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
14.3%
1/7 • 7 years, 4 months
|
|
General disorders
Flu-like syndrome
|
14.3%
1/7 • 7 years, 4 months
|
Additional Information
S. R. Burzynski, MD, PhD
Burzynski Research Institute, Inc.
Phone: 713-335-5664
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place