Trial Outcomes & Findings for Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme (NCT NCT00003474)

NCT ID: NCT00003474

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

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

12 months

Results posted on

2018-03-22

Participant Flow

Forty patients were recruited between March 1996 and April 2003. All study subjects were seen at the Burzynski Clinic in Houston TX

Participant milestones

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 residual/recurrent/progressive Glioblastoma Multiforme 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 Study
STARTED
40
Overall Study
COMPLETED
26
Overall Study
NOT COMPLETED
14

Reasons for withdrawal

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 residual/recurrent/progressive Glioblastoma Multiforme 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 Study
Not Evaluable
14

Baseline Characteristics

Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Antineoplaston Therapy
n=40 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 residual/recurrent/progressive Glioblastoma Multiforme 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
48.8 Years
n=5 Participants
Sex: Female, Male
Female
24 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure
Antineoplaston Therapy
n=26 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 residual/recurrent/progressive Glioblastoma Multiforme 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.
Number of Participants With Objective Response
Complete Response
1 Participants
Number of Participants With Objective Response
Partial Response
1 Participants
Number of Participants With Objective Response
Stable Disease
5 Participants
Number of Participants With Objective Response
Progressive Disease
19 Participants

SECONDARY outcome

Timeframe: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Population: All study subjects receiving any Antineoplaston therapy

6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival

Outcome measures

Outcome measures
Measure
Antineoplaston Therapy
n=40 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 residual/recurrent/progressive Glioblastoma Multiforme 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
36 months overall survival
2.5 Percentage of participants
Percentage of Participants Who Survived
48 months overall survival
2.5 Percentage of participants
Percentage of Participants Who Survived
6 months overall survival
45.0 Percentage of participants
Percentage of Participants Who Survived
12 months overall survival
22.5 Percentage of participants
Percentage of Participants Who Survived
24 months overall survival
2.5 Percentage of participants
Percentage of Participants Who Survived
60 months overall survival
2.5 Percentage of participants

Adverse Events

Antineoplaston Therapy

Serious events: 17 serious events
Other events: 40 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Antineoplaston Therapy
n=40 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 residual/recurrent/progressive Glioblastoma Multiforme 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.
Blood and lymphatic system disorders
Hemoglobin
2.5%
1/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders
Hypertension
2.5%
1/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders
Central Venous Catheter Infection
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders
Dehydration
2.5%
1/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders
Vomiting
2.5%
1/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection (documented clinically): Bladder (urinary)
2.5%
1/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders
Infection (documented clinically): Lung (pneumonia)
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Musculoskeletal and connective tissue disorders
Muscle weakness: Whole body/generalized
2.5%
1/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Seizure
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Somnolence/depressed level of consciousness
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Syncope (fainting)
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Pain: Head/headache
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Vascular disorders
Thrombosis/thrombus/embolism
2.5%
1/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX

Other adverse events

Other adverse events
Measure
Antineoplaston Therapy
n=40 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 residual/recurrent/progressive Glioblastoma Multiforme 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)
17.5%
7/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Ear and labyrinth disorders
Tinnitus
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders
Hemoglobin
17.5%
7/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders
Leukocytes (total WBC)
10.0%
4/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders
Lymphopenia
20.0%
8/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders
Platelets
12.5%
5/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus bradycardia
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders
Hypertension
12.5%
5/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders
Hypotension
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Central Venous Catheter: Infection
12.5%
5/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders
Central Venous Catheter: Non-functional
30.0%
12/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders
Central Venous Catheter: Other
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders
Central Venous Catheter: Thrombosis/embolism
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders
Constitutional Symptoms - Other
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders
Fatigue (asthenia, lethargy, malaise)
57.5%
23/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders
Insomnia
10.0%
4/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders
Weight gain
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders
Fever
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders
Edema
52.5%
21/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Endocrine disorders
Cushingoid appearance
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders
Anorexia
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders
Constipation
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders
Diarrhea
12.5%
5/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders
Nausea
37.5%
15/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders
Vomiting
27.5%
11/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Renal and urinary disorders
Hemorrhage, GU: Urinary NOS
10.0%
4/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection (documented clinically): Bladder (urinary)
10.0%
4/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection (documented clinically): Blood
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection (documented clinically): Lung (pneumonia)
10.0%
4/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection (documented clinically): Mucosa
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection (documented clinically): Sinus
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection (documented clinically): Upper airway NOS
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection (documented clinically): Urinary tract NOS
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection: Lung (pneumonia)
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection: Mucosa
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations
Infection: Opportunistic infection
12.5%
5/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Albumin, serum-low (hypoalbuminemia)
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Alkaline phosphatase
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
GGT (gamma-Glutamyl transpeptidase)
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Hypercholesteremia
10.0%
4/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Hyperglycemia
30.0%
12/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Hypernatremia
62.5%
25/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Hypertriglyceridemia
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Hypocalcemia
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Hypoglycemia
17.5%
7/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Hypokalemia
85.0%
34/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Hypomagnesemia
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Hyponatremia
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
Proteinuria
12.5%
5/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
SGOT
15.0%
6/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations
SGPT
20.0%
8/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Ataxia (incoordination)
10.0%
4/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Confusion
47.5%
19/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Dizziness
37.5%
15/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Memory impairment
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Mood alteration: Agitation
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Mood alteration: Anxiety
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Mood alteration: Depression
10.0%
4/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Neuropathy: motor
15.0%
6/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Psychosis (hallucinations/delusions)
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Seizure
32.5%
13/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Somnolence/depressed level of consciousness
55.0%
22/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Speech impairment
12.5%
5/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Syncope (fainting)
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Tremor
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Diplopia
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Ophthalmoplegia/diplopia (double vision)
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Vision-blurred vision
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Musculoskeletal and connective tissue disorders
Pain: Back
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Pain: Head/headache
37.5%
15/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Musculoskeletal and connective tissue disorders
Pain: Joint
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders
Pain: Muscle
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders
Cough
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
22.5%
9/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Renal and urinary disorders
Incontinence, urinary
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Renal and urinary disorders
Urinary frequency/urgency
5.0%
2/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX
Vascular disorders
Thrombosis/thrombus/embolism
7.5%
3/40 • 7 years, 3 months
Forty patients were recruited between March 1996 and June 2003. All study subjects were seen at the Burzynski Clinic in Houston TX

Additional Information

S. R. Burzynski, MD, PhD

Burzynski Research Institute, Inc.

Phone: 713-335-5664

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place