Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas (NCT NCT00003473)

Last Updated: 2018-01-17

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

20 participants

Primary outcome timeframe

12 months

Results posted on

2018-01-17

Participant Flow

Twenty patients were recruited between March 1996 and May 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, to mitigate adverse reactions to treatment, until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

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, to mitigate adverse reactions to treatment, until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Overall Study Three patients were not evaluable.	3

Baseline Characteristics

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antineoplaston Therapy n=20 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 or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Age, Continuous	37.3 Years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Antineoplaston Therapy n=17 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 or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Number of Participants With Objective Response Complete Response	3 Participants
Number of Participants With Objective Response Partial Response	0 Participants
Number of Participants With Objective Response Stable Disease	4 Participants
Number of Participants With Objective Response Progressive Disease	10 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=20 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 or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Percentage of Participants Who Survived 6 months overall survival	65.0 Percentage of participants
Percentage of Participants Who Survived 12 months overall survival	55.0 Percentage of participants
Percentage of Participants Who Survived 24 months overall survival	30.0 Percentage of participants
Percentage of Participants Who Survived 36 months overall survival	30.0 Percentage of participants
Percentage of Participants Who Survived 48 months overall survival	20.0 Percentage of participants
Percentage of Participants Who Survived 60 months overall survival	15.0 Percentage of participants

Adverse Events

Antineoplaston Therapy

Serious events: 8 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Antineoplaston Therapy n=20 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 or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Infections and infestations Central venous catheter infection	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Non-functional central venous catheter	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Seizure	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Somnolence/depressed level of consciousness	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Pain: Head/headache	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Thrombosis/thrombus/embolism	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing

Other adverse events

Other adverse events
Measure	Antineoplaston Therapy n=20 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 or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	20.0% 4/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Immune system disorders Allergy/Immunology - Other	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Ear and labyrinth disorders Auditory/Ear - Other	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Ear and labyrinth disorders Hearing (without monitoring program)	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Ear and labyrinth disorders Tinnitus	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Hemoglobin	25.0% 5/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Leukocytes (total WBC)	20.0% 4/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Platelets	20.0% 4/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Cardiac disorders Palpitations	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Cardiac disorders Hypertension	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Central Venous Catheter Infection	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Central Venous Catheter Non-functional	30.0% 6/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Central Venous Catheter Thrombosis/embolism	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders INR (International Normalized Ratio of prothrombin time)	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fatigue (asthenia, lethargy, malaise)	65.0% 13/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fever	25.0% 5/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Insomnia	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Rigors/chills	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Alopecia	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Pruritus/itching	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Rash/desquamation	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Edema/Fluid retention	35.0% 7/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Endocrine disorders Cushingoid appearance	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Endocrine disorders Hot flashes/flushes	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Anorexia	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Constipation	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Diarrhea	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Dysphagia (difficulty swallowing)	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Gastrointestinal - Other	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Heartburn/dyspepsia	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Nausea	45.0% 9/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Taste alteration (dysgeusia)	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Vomiting	45.0% 9/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Hemorrhage, GI: Upper GI NOS	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Hemorrhage, GU	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Hemorrhage, GU: Bladder	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Hemorrhage, GU: Urinary NOS	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Bladder (urinary)	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Lung (pneumonia)	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection: Mucosa	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection: Other	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection: Stomach	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection: Upper airway	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Albumin, serum-low (hypoalbuminemia)	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Alkaline phosphatase	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations GGT (gamma-Glutamyl transpeptidase)	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypercholesteremia	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyperglycemia	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypernatremia	75.0% 15/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypertriglyceridemia	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypocalcemia	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypoglycemia	30.0% 6/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypokalemia	80.0% 16/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypomagnesemia	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypophosphatemia	25.0% 5/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Metabolic/Laboratory - Other	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Proteinuria	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGOT	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGPT	20.0% 4/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Uric acid, serum-high (hyperuricemia)	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Muscle weakness: Whole body/generalized	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Musculoskeletal-Other	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Ataxia (incoordination)	25.0% 5/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Confusion	35.0% 7/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Dizziness	45.0% 9/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Memory impairment	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Mood alteration	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Mood alteration: Agitation	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Neuropathy - cranial	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Neuropathy - motor	15.0% 3/20 • 10 years, 4 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	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Neuropathy: sensory	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Psychosis (hallucinations/delusions)	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Seizure	30.0% 6/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Somnolence/depressed level of consciousness	55.0% 11/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Speech impairment	35.0% 7/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Tremor	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Eye disorders Diplopia	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Eye disorders Ophthalmoplegia/diplopia (double vision)	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Eye disorders Vision-blurred vision	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Eye disorders Vision-photophobia	10.0% 2/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Pain: Abdomen NOS	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Back	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Pain: Head/headache	55.0% 11/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Joint	20.0% 4/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Muscle	15.0% 3/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain-Other	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	20.0% 4/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Urinary frequency/urgency	25.0% 5/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Vascular disorders Phlebitis (including superficial thrombosis)	5.0% 1/20 • 10 years, 4 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Thrombosis/thrombus/embolism	10.0% 2/20 • 10 years, 4 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