Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer (NCT NCT00003531)

Last Updated: 2021-01-07

Results Overview

An objective response can be complete or partial. A complete response is complete disappearance of all tumor(s) by physical examination and radiographic studies for a minimum of 4 weeks. A partial response is \> 50% reduction in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, lasting for a minimum of four months. Stable disease is \< 50% change in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of 12 months.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

14 months

Results posted on

2021-01-07

Participant Flow

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): Patients with Stage IV Pancreatic Cancer 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	15
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	10

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): Patients with Stage IV Pancreatic Cancer 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	10

Baseline Characteristics

Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antineoplaston Therapy n=15 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 Stage IV Pancreatic Cancer 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	60.7 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 months

Outcome measures

Outcome measures
Measure	Antineoplaston Therapy n=5 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 Stage IV Pancreatic Cancer 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 and Stable Disease Stable Disease	1 participants
Number of Participants With Objective Response and Stable Disease Progressive Disease	4 participants

Adverse Events

Antineoplaston Therapy

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Antineoplaston Therapy n=15 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 Stage IV Pancreatic Cancer 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.
Infections and infestations Central Venous Catheter Infection	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Skin and subcutaneous tissue disorders Edema/Fluid retention	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Constipation	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Hemorrhage, GI	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Lung (pneumonia)	13.3% 2/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Confusion	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Somnolence/depressed level of consciousness	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Pain: Abdomen NOS	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX

Other adverse events

Other adverse events
Measure	Antineoplaston Therapy n=15 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 Stage IV Pancreatic Cancer 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 Allergic reaction/hypersensitivity (including drug fever)	13.3% 2/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Ear and labyrinth disorders tinnitus	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders Hemoglobin	20.0% 3/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Blood and lymphatic system disorders Lymphopenia	20.0% 3/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Central Venous Catheter Infection	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations PT	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations PTT	13.3% 2/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Fatigue (asthenia, lethargy, malaise)	40.0% 6/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Fever	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Rigors/chills	13.3% 2/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Skin and subcutaneous tissue disorders Pruritus/itching	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Edema/Fluid retention	53.3% 8/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Constipation	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Diarrhea	26.7% 4/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Gastrointestinal-Other	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Nausea	40.0% 6/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Taste alteration (dysgeusia)	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Vomiting	13.3% 2/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Hemorrhage, GI	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Blood	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Lung (pneumonia)	20.0% 3/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Mucosa	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Infection (documented clinically): Soft tissue NOS	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Infections and infestations Opportunistic infection	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Albumin, serum-low (hypoalbuminemia)	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hyperbilirubinemia	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hyperglycemia	40.0% 6/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypernatremia	53.3% 8/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypocalcemia	13.3% 2/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypoglycemia	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypokalemia	80.0% 12/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hypomagnesemia	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations Hyponatremia	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Investigations SGOT	26.7% 4/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Confusion	40.0% 6/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Dizziness	13.3% 2/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Psychosis (hallucinations/delusions)	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Somnolence/depressed level of consciousness	33.3% 5/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Nervous system disorders Speech impairment	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Gastrointestinal disorders Pain: Abdomen NOS	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
General disorders Pain: Head/headache	13.3% 2/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Musculoskeletal and connective tissue disorders Pain: Joint	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Renal and urinary disorders Urinary frequency/urgency	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 2005. All study subjects were seen at the Burzynski Clinic in Houston TX
Vascular disorders Thrombosis/thrombus/embolism	6.7% 1/15 • 9 years, 3 months Fifteen patients were recruited between April 10, 1996 and July 18, 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