Trial Outcomes & Findings for Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma (NCT NCT00003468)

Last Updated: 2023-11-21

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

11 participants

Primary outcome timeframe

12 months

Results posted on

2023-11-21

Participant Flow

Eleven patients were recruited between July 1996 and November 2005. 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. Children with a low-grade astrocytoma who have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antineoplaston Therapy n=11 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): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Age, Continuous	9.3 Years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Antineoplaston Therapy n=9 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): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Number of Participants With Objective Response Complete Response	4 Participants
Number of Participants With Objective Response Partial Response	1 Participants
Number of Participants With Objective Response Stable Disease	4 Participants
Number of Participants With Objective Response Progressive Disease	0 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=11 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): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Percentage of Participants Who Survived 6 months overall survival	81.8 Percentage of participants
Percentage of Participants Who Survived 12 months overall survival	81.8 Percentage of participants
Percentage of Participants Who Survived 24 months overall survival	63.6 Percentage of participants
Percentage of Participants Who Survived 36 months overall survival	63.6 Percentage of participants
Percentage of Participants Who Survived 48 months overall survival	63.6 Percentage of participants
Percentage of Participants Who Survived 60 months overall survival	63.6 Percentage of participants

Adverse Events

Antineoplaston Therapy

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Antineoplaston Therapy n=11 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): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Infections and infestations Central venous catheter infection	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fever	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Chicken pox	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypernatremia	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Seizure	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Pain: Abdomen NOS	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Renal/Genitourinary-Other: kidney stones	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing

Other adverse events

Other adverse events
Measure	Antineoplaston Therapy n=11 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): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
General disorders Allergic reaction/hypersensitivity (including drug fever)	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Allergic rhinitis (including sneezing, nasal stuffiness, 2 2	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Blood/Bone Marrow - Other	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Hemoglobin	45.5% 5/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Leukocytes (total WBC)	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Lymphopenia	72.7% 8/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Platelets	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Cardiac disorders Supraventricular and nodal arrhythmia: Sinus bradycardia	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Cardiac disorders Supraventricular and nodal arrhythmia: Sinus tachycardia	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Central venous catheter infection	45.5% 5/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Non-functional central venous cateter	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Pain : Central venous catheter	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Central venous catheter: Thrombosis/embolism	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders PTT (Partial Thromboplastin Time)	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Constitutional Symptoms - Other	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fatigue (asthenia, lethargy, malaise)	72.7% 8/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fever	45.5% 5/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Obesity	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Rigors/chills	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Weight gain	45.5% 5/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Weight loss	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Bruising (in absence of Grade 3 or 4 thrombocytopenia)	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Flushing	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Petechiae	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Pruritus/itching	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Rash/desquamation	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Rash: acne/acneiform	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Striae	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Edema/Fluid retention	72.7% 8/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Endocrine disorders Cushingoid	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Endocrine disorders Cushingoid appearance	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Endocrine disorders Endocrine - Other	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Endocrine disorders Hot flashes/flushes	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Anorexia	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Ascites (non-malignant)	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Constipation	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Dehydration	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Diarrhea	72.7% 8/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Distension/bloating, abdominal	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	54.5% 6/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Dysphagia (difficulty swallowing)	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Gastrointestinal - Other	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Heartburn/dyspepsia	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Nausea	72.7% 8/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Vomiting	72.7% 8/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Hemorrhage, GU: Urinary NOS	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Chicken pox	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection - Other	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Lung (pneumonia)	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Middle ear (otitis)	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Blood	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Pharynx	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Sinus	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Upper airway NOS	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Opportunistic infection	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Albumin, serum-low (hypoalbuminemia)	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Alkaline phosphatase	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Bicarbonate, serum-low	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypercholesterolemia	54.5% 6/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyperglycemia	72.7% 8/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyperkalemia	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypernatremia	81.8% 9/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypertriglyceridemia	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyperuricemia	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypocalcemia	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypoglycemia	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypokalemia	81.8% 9/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypomagnesemia	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyponatremia	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypophosphatemia	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Metabolic/Laboratory - Other	45.5% 5/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Proteinuria	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGOT	45.5% 5/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGPT	54.5% 6/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Uric acid, serum-high (hyperuricemia)	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Muscle weakness: Extremity-lower	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Muscle weakness: Whole body/generalized	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Musculoskeletal-Other	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Ataxia (incoordination)	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Confusion	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Dizziness	63.6% 7/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Memory impairment	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Mood alteration: Agitation	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Mood alteration: Depression	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Neurology - Other	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Neuropathy - cranial	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Neuropathy: CN III Pupil, upper eyelid, extra ocular movements	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Neuropathy: sensory	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Seizure	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Somnolence/depressed level of consciousness	63.6% 7/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Speech impairment	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Syncope (fainting)	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Tremor	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Eye disorders Vision-blurred vision	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Eye disorders Vision-flashing lights/floaters	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Eye disorders Vision-photophobia	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Pain: Abdomen NOS	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Back	36.4% 4/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Buttock	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Chest/thorax NOS	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Extremity-limb	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Pain: Head/headache	63.6% 7/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Joint	45.5% 5/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Pain: Lymph node	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Muscle	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Neck	27.3% 3/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Pain: Scalp	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Pain: Throat/pharynx/larynx	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Pain: Urethra	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other	18.2% 2/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Renal/Genitourinary-Other: kidney stones	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Renal/Genitourinary-Other	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Urinary frequency/urgency	63.6% 7/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Vascular disorders Vascular - Other	9.1% 1/11 • 9 years, 6 months Adverse event data was collected through regular patient assessment and regular laboratory testing

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