Trial Outcomes & Findings for Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma (NCT NCT00003537)

Last Updated: 2017-08-24

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; 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

12 months

Results posted on

2017-08-24

Participant Flow

Nineteen patients were recruited between April 1995 and October 2008. 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 or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
Overall Study STARTED	19
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	1

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 or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
Overall Study Not evalauable	1

Baseline Characteristics

Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antineoplaston Therapy n=19 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 or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
Age, Continuous	44.0 Years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Antineoplaston Therapy n=18 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 or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
Number of Participants With Objective Response Complete Response	3 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	9 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=19 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 or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
Percentage of Participants Who Survived 6 months overall survival	68.4 Percentage of participants
Percentage of Participants Who Survived 12 months overall survival	52.6 Percentage of participants
Percentage of Participants Who Survived 24 months overall survival	36.8 Percentage of participants
Percentage of Participants Who Survived 36 months overall survival	26.3 Percentage of participants
Percentage of Participants Who Survived 48 months overall survival	26.3 Percentage of participants
Percentage of Participants Who Survived 60 months overall survival	21.1 Percentage of participants

Adverse Events

Antineoplaston Therapy

Serious events: 11 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Antineoplaston Therapy n=19 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 an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
Cardiac disorders Supraventricular and nodal arrhythmia: Atrial fibrillation	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Ventricular arrhythmia: Ventricular tachycardia	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Hypotension	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Pericardial effusion (non-malignant)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Central venous catheter infection	21.1% 4/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Thrombosis/embolism	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Fever	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Rigors/chills	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Hemorrhage, CNS	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders Infection (documented clinically): Lung (pneumonia)	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Bladder (urinary)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypokalemia	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Neuropathy: motor	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Seizure	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Somnolence/depressed level of consciousness	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Eye disorders Diplopia	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Vascular disorders Thrombosis/embolism (vascular access-related)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Vascular disorders Thrombosis/thrombus/embolism	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX

Other adverse events

Other adverse events
Measure	Antineoplaston Therapy n=19 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 an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	31.6% 6/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Ear and labyrinth disorders Auditory/Ear - Other	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders Hemoglobin	26.3% 5/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders Leukocytes (total WBC)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders Lymphopenia	36.8% 7/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders Platelets	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Palpitations	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Supraventricular and nodal arrhythmia: Atrial fibrillation	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Supraventricular and nodal arrhythmia: Sinus tachycardia	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Ventricular arrhythmia: Ventricular tachycardia	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Hypertension	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Hypotension	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Left ventricular systolic dysfunction	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Pericardial effusion (non-malignant)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Central venous catheter infection	31.6% 6/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Non-functional central venous catheter	31.6% 6/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Central venous catheter - Other	31.6% 6/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Pain: Central venous catheter	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Central venous catheter thrombosis/embolism	26.3% 5/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Fatigue (asthenia, lethargy, malaise)	47.4% 9/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Fever	26.3% 5/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Rigors/chills	21.1% 4/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Sweating (diaphoresis)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Weight gain	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Skin and subcutaneous tissue disorders Dry skin	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Skin and subcutaneous tissue disorders Nail changes	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Skin and subcutaneous tissue disorders Pruritus/itching	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Edema/Fluid retention	42.1% 8/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Diarrhea	21.1% 4/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Gastrointestinal - Other	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Heartburn/dyspepsia	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Nausea	26.3% 5/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Taste alteration (dysgeusia)	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Vomiting	36.8% 7/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Hemorrhage, CNS	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Renal and urinary disorders Hemorrhage, GU: Bladder	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Renal and urinary disorders Hemorrhage, GU: Urinary NOS	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Skin and subcutaneous tissue disorders Petechiae	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection - Other	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Bladder (urinary)	21.1% 4/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Middle ear (otitis	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Blood	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Bronchus	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Lung (pneumonia)	21.1% 4/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Mucosa	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Neck NOS	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Oral cavity-gums (gingivitis)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Sinus	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Upper airway NOS	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Opportunistic infection	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders Edema:head and neck	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Albumin, serum-low (hypoalbuminemia)	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Alkaline phosphatase	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations GGT (gamma-Glutamyl transpeptidase)	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hyperbilirubinemia	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypercalcemia	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypercholesteremia	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hyperglycemia	36.8% 7/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypernatremia	63.2% 12/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypertriglyceridemia	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hyperuricemia	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypocalcemia	21.1% 4/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypokalemia	94.7% 18/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypoglycemia	26.3% 5/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypomagnesemia	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hyponatremia	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypophosphatemia	21.1% 4/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Metabolic/Laboratory - Other	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Renal and urinary disorders Proteinuria	26.3% 5/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations SGOT	36.8% 7/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations SGPT	42.1% 8/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Uric acid, serum-high (hyperuricemia)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Ataxia (incoordination)	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Confusion	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Dizziness	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Mood alteration	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Mood alteration: Agitation	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Neurology - Other	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Mood alteration: Anxiety	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Neuropathy: motor	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Neuropathy: sensory	21.1% 4/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Psychosis (hallucinations/delusions)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Pyramidal tract dysfunction	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Seizure	31.6% 6/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Somnolence/depressed level of consciousness	52.6% 10/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Speech impairment	21.1% 4/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Ear and labyrinth disorders Diplopia	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Eye disorders Nystagmus	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Eye disorders Vision-blurred vision	26.3% 5/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Eye disorders Vision-photophobia	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Pain: Abdomen NOS	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Musculoskeletal and connective tissue disorders Pain: Back	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders Pain: Chest/thorax NOS	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Ear and labyrinth disorders Pain: External ear	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Musculoskeletal and connective tissue disorders Pain: Extremity-limb	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Pain: Head/headache	68.4% 13/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Musculoskeletal and connective tissue disorders Pain: Joint	31.6% 6/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Ear and labyrinth disorders Pain: Middle ear	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Metabolism and nutrition disorders Pain: Muscle	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Musculoskeletal and connective tissue disorders Pain: Neck	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Renal and urinary disorders Urinary frequency/urgency	26.3% 5/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Flu-like syndrome	15.8% 3/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Vascular disorders Thrombosis/embolism (vascular access-related)	10.5% 2/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders Thrombosis/thrombus/embolism	5.3% 1/19 • 13 years, 6 months Nineteen patients were recruited between April 1995 and October 2008. 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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place