Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma (NCT NCT00003470)

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

27 participants

Primary outcome timeframe

12 months

Results posted on

2017-08-24

Participant Flow

Twenty-seven patients were recruited between March 1996 and November 2007. 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 an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Overall Study STARTED	27
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	6

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 an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Overall Study Not evaluable	6

Baseline Characteristics

Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antineoplaston Therapy n=27 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 an anaplastic astrocytoma that has not responded to standard therapy 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	41.5 Years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Antineoplaston Therapy n=21 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 an anaplastic astrocytoma that has not responded to standard therapy 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	2 Participants
Number of Participants With Objective Response Partial Response	3 Participants
Number of Participants With Objective Response Stable Disease	6 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=27 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 an anaplastic astrocytoma that has not responded to standard therapy 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 48 months overall survival	14.8 Percentage of participants
Percentage of Participants Who Survived 6 months overall survival	63.0 Percentage of participants
Percentage of Participants Who Survived 12 months overall survival	40.7 Percentage of participants
Percentage of Participants Who Survived 24 months overall survival	29.6 Percentage of participants
Percentage of Participants Who Survived 36 months overall survival	22.2 Percentage of participants
Percentage of Participants Who Survived 60 months overall survival	11.1 Percentage of participants

Adverse Events

Antineoplaston Therapy

Serious events: 12 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Antineoplaston Therapy n=27 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 that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Infections and infestations Central venous catheter infection	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fatigue (asthenia, lethargy, malaise)	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Edema/Fluid retention	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Vomiting	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Bladder (urinary)	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Lung (pneumonia)	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Skin (cellulitis)	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection with normal ANC: Brain + Spinal cord (encephalomyelitis)	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Lung (pneumonia)	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypernatremia	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypokalemia	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGPT	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Ataxia (incoordination)	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Confusion	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Mood alteration: Agitation	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Seizure	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Somnolence/depressed level of consciousness	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Tremor	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other (Pneumonia)	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Vascular disorders Thrombosis/thrombus/embolism	3.7% 1/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing

Other adverse events

Other adverse events
Measure	Antineoplaston Therapy n=27 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 that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	14.8% 4/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness,	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Ear and labyrinth disorders Tinnitus	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Hemoglobin	22.2% 6/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Leukocytes (total WBC)	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Lymphopenia	14.8% 4/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Platelets	14.8% 4/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Cardiac disorders Hypertension	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Central venous catheter infection	25.9% 7/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Non-functional central venous catheter	33.3% 9/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Central venous catheter - Other	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Pain: Central venous catheter	14.8% 4/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Central venous catheter thrombosis/embolism	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fatigue (asthenia, lethargy, malaise)	74.1% 20/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fever	14.8% 4/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Insomnia	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Rigors/chills	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Weight gain	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Edema/Fluid retention	51.9% 14/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Endocrine disorders Hot flashes/flushes	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Diarrhea	18.5% 5/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	18.5% 5/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Heartburn/dyspepsia	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Nausea	44.4% 12/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Taste alteration (dysgeusia)	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Vomiting	25.9% 7/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Hemorrhage, GU: Urinary NOS	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Bladder (urinary)	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Lung (pneumonia)	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Skin (cellulitis)	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Upper airway NOS	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Opportunistic infection	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Albumin, serum-low (hypoalbuminemia)	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Alkaline phosphatase	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypercholesteremia	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyperglycemia	37.0% 10/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyperkalemia	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypernatremia	77.8% 21/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypocalcemia	25.9% 7/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypoglycemia	22.2% 6/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypokalemia	81.5% 22/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypomagnesemia	18.5% 5/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyponatremia	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypophosphatemia	14.8% 4/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Metabolic/Laboratory - Other	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Proteinuria	25.9% 7/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGOT	22.2% 6/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGPT	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Ataxia (incoordination)	14.8% 4/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Confusion	37.0% 10/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Dizziness	33.3% 9/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Mood alteration: Agitation	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Neuropathy: motor	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Psychosis (hallucinations/delusions)	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Seizure	25.9% 7/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Somnolence/depressed level of consciousness	63.0% 17/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Speech impairment	25.9% 7/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Tremor	14.8% 4/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Eye disorders Vision-blurred vision	7.4% 2/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Back	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Extremity-limb	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Pain: Head/headache	33.3% 9/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Joint	11.1% 3/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	14.8% 4/27 • 12 years, nine months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Urinary frequency/urgency	18.5% 5/27 • 12 years, nine 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