Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme (NCT NCT00003456)

Last Updated: 2018-03-22

Results Overview

Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

12 months

Results posted on

2018-03-22

Participant Flow

Forty patients were recruited between March 1995 and June 2004. 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 newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Overall Study STARTED	40
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	8

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 newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Overall Study Not evaluable	8

Baseline Characteristics

Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antineoplaston Therapy n=40 Participants Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Age, Continuous	52.4 Years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Antineoplaston Therapy n=32 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 newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Number of Participants With Objective Response Complete Response	2 Participants
Number of Participants With Objective Response Partial Response	1 Participants
Number of Participants With Objective Response Stable Disease	2 Participants
Number of Participants With Objective Response Progressive Disease	27 Participants

SECONDARY outcome

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

Population: All study subjects receiving any Antineoplaston therapy

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

Outcome measures

Outcome measures
Measure	Antineoplaston Therapy n=40 Participants Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Percentage of Participants Who Survived 6 months overall survival	27.5 Percentage of participants
Percentage of Participants Who Survived 12 months overall survival	12.5 Percentage of participants
Percentage of Participants Who Survived 24 months overall survival	7.5 Percentage of participants
Percentage of Participants Who Survived 36 months overall survival	5.0 Percentage of participants
Percentage of Participants Who Survived 48 months overall survival	2.5 Percentage of participants
Percentage of Participants Who Survived 60 months overall survival	2.5 Percentage of participants

Adverse Events

Antineoplaston Therapy

Serious events: 18 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Antineoplaston Therapy n=40 participants at risk Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
General disorders Central venous catheter: Infection	2.5% 1/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders The Central venous catheter: Thrombosis/embolism.	2.5% 1/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Fatigue (asthenia, lethargy, malaise)	2.5% 1/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Skin and subcutaneous tissue disorders Injection site reaction/extravasation changes	2.5% 1/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Vomiting	2.5% 1/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Hemorrhage, CNS	2.5% 1/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Bladder (urinary)	2.5% 1/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Lung (pneumonia)	2.5% 1/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypernatremia	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Seizure	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Somnolence/depressed level of consciousness	17.5% 7/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Syncope (fainting)	2.5% 1/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Pain: Head/headache	7.5% 3/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	2.5% 1/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Vascular disorders Thrombosis/thrombus/embolism	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX

Other adverse events

Other adverse events
Measure	Antineoplaston Therapy n=40 participants at risk Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	25.0% 10/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders Leukocytes (total WBC)	7.5% 3/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders Lymphopenia	17.5% 7/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Cardiac disorders Hypertension	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Central Venous Catheter: Infection	10.0% 4/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Central Venous Catheter: Non-functional	17.5% 7/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Central Venous Catheter: Other	10.0% 4/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Central Venous Catheter: Pain	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Fatigue (asthenia, lethargy, malaise)	70.0% 28/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Fever	15.0% 6/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Edema/Fluid retention	37.5% 15/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Diarrhea	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Nausea	30.0% 12/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Taste alteration (dysgeusia)	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Vomiting	27.5% 11/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Renal and urinary disorders Hemorrhage, GU	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Renal and urinary disorders Infection (documented clinically): Bladder (urinary)	10.0% 4/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Lung (pneumonia)	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Mucosa	7.5% 3/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Upper airway NOS	12.5% 5/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection: Upper airway	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hyperbilirubinemia	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hyperglycemia	30.0% 12/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypernatremia	42.5% 17/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypocalcemia	7.5% 3/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypoglycemia	20.0% 8/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypokalemia	62.5% 25/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Proteinuria	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations SGOT	17.5% 7/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations SGPT	22.5% 9/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Ataxia (incoordination)	10.0% 4/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Confusion	30.0% 12/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Dizziness	25.0% 10/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Neuropathy: motor	5.0% 2/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Seizure	17.5% 7/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Somnolence/depressed level of consciousness	52.5% 21/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Speech impairment	20.0% 8/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Pain: Head/headache	40.0% 16/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Musculoskeletal and connective tissue disorders Pain: Joint	12.5% 5/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	17.5% 7/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
Vascular disorders Thrombosis/thrombus/embolism 1 2 3	7.5% 3/40 • 9 years, 6 months Forty patients were recruited between March 1995 and December 2004. 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