Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma (NCT NCT00003508)

Last Updated: 2021-04-27

Results Overview

Objective response rate per The International Working Group response criteria (1999): 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 lesions, sustained for at least four weeks. Stable Disease (SD), \< 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

109 months

Results posted on

2021-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Arm: Experimental: 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): Patients with advanced mesothelioma 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.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Overall Study STARTED	8
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm: Experimental: 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): Patients with advanced mesothelioma 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.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Overall Study Not evaluable	5

Baseline Characteristics

Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm: Experimental: Antineoplaston Therapy n=3 Evaluable Patients 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): Patients with advanced mesothelioma 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.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Age, Continuous	60.0 years STANDARD_DEVIATION 8.9527 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 109 months

Population: All patients enrolled in the study.

Outcome measures

Outcome measures
Measure	Arm: Experimental: Antineoplaston Therapy n=8 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): Patients with advanced mesothelioma 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.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable Objective Response	0 participants
Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable Stable Disease	2 participants
Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable Progressive Disease	1 participants
Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable Not evaluable	5 participants

Adverse Events

Arm: Experimental: Antineoplaston Therapy

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm: Experimental: Antineoplaston Therapy n=8 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): Patients with advanced mesothelioma 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.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary: Bronchopulmonary NOS	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Infections and infestations Infection NOS	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Nervous system disorders Seizure	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.

Other adverse events

Other adverse events
Measure	Arm: Experimental: Antineoplaston Therapy n=8 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): Patients with advanced mesothelioma 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.hourly interEach infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
General disorders Allergic reaction/hypersensitivity (including drug fever)	25.0% 2/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
General disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	25.0% 2/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Blood and lymphatic system disorders Hemoglobin	25.0% 2/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Blood and lymphatic system disorders Lymphopenia	25.0% 2/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Cardiac disorders Hypertension	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Cardiac disorders Hypotension	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Infections and infestations Central Venous Catheter Infection	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
General disorders Fatigue (asthenia, lethargy, malaise)	62.5% 5/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
General disorders Fever	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
General disorders Rigors/chills	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Skin and subcutaneous tissue disorders Flushing	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Skin and subcutaneous tissue disorders Pruritus/itching	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
General disorders Edema/Fluid retention	37.5% 3/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Endocrine disorders Cushingoid appearance	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Gastrointestinal disorders Constipation	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Gastrointestinal disorders Diarrhea	37.5% 3/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Gastrointestinal disorders Heartburn/dyspepsia	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Gastrointestinal disorders Nausea	37.5% 3/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Gastrointestinal disorders Taste alteration (dysgeusia)	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary: Bronchopulmonary NOS	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary: Nose	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Infections and infestations Infection	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Infections and infestations Infection (documented clinically): Bronchus	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Infections and infestations Infection (documented clinically): Skin (cellulitis)	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Infections and infestations Opportunistic infection	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Investigations Albumin, serum-low (hypoalbuminemia)	25.0% 2/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Investigations Alkaline phosphatase	25.0% 2/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Investigations Hyperglycemia	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Investigations Hyperkalemia	12.5% 1/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Investigations Hypernatremia	50.0% 4/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. All study subjects were seen at the Burzynski Clinic in Houston TX.
Investigations Hypocalcemia	25.0% 2/8 • 9 years, 1 month Eight patients were recruited between March 1966 and April 2005. 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