Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer (NCT NCT00003453)

Last Updated: 2018-05-09

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

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

12 months

Results posted on

2018-05-09

Participant Flow

Six patients were recruited between August 1996 and February 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): Patients with Stage IV Adrenal Gland 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	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antineoplaston Therapy n=6 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 Adrenal Gland 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	45.0 years n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants

PRIMARY outcome

Timeframe: 12 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 Adrenal Gland 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 Complete Response	1 Participants
Number of Participants With Objective Response Partial Response	1 Participants
Number of Participants With Objective Response Stable Disease	1 Participants
Number of Participants With Objective Response Progressive Disease	2 Participants

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Antineoplaston Therapy n=6 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 Adrenal Gland 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.
Percentage of Participants Who Survived 24 months overall survival	50.0 Percentage of participants
Percentage of Participants Who Survived 36 months overall survival	33.3 Percentage of participants
Percentage of Participants Who Survived 6 months overall survival	83.3 Percentage of participants
Percentage of Participants Who Survived 12 months overall survival	66.7 Percentage of participants
Percentage of Participants Who Survived 48 months overall survival	33.3 Percentage of participants
Percentage of Participants Who Survived 60 months overaall survival	33.3 Percentage of participants

Adverse Events

Antineoplaston Therapy

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Antineoplaston Therapy n=6 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 Adrenal Gland 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.
Gastrointestinal disorders Ascites (non-malignant)	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Muscle Spasms)	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fever	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Central Venous Catheter Infection	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Somnolence/depressed level of consciousness	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Dizziness	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing

Other adverse events

Other adverse events
Measure	Antineoplaston Therapy n=6 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 Adrenal Gland 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.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Hemoglobin	66.7% 4/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Leukocytes (total WBC)	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Lymphopenia	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Platelets	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Cardiac disorders Cardiac Arrhythmia - Other	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Cardiac disorders Hypertension	50.0% 3/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Central venous catheter infection	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Non-functional central venous catheter	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Central venous catheter - Other	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Pain: Central venous catheter	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fatigue (asthenia, lethargy, malaise)	83.3% 5/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fever	50.0% 3/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Insomnia	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Rigors/chills	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Sweating (diaphoresis)	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Pruritus/itching	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Edema/Fluid retention	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Anorexia	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Ascites (non-malignant)	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Constipation	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Dental: teeth	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Diarrhea	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Enteritis (inflammation of the small bowel)	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Nausea	83.3% 5/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Vomiting	66.7% 4/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Hemorrhage, GU: Bladder	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection - Other	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Bladder (urinary)	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Bronchus	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Dental-tooth	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Mucosa	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Upper airway NOS	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection with normal ANC: Abdomen NOS	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Albumin, serum-low (hypoalbuminemia)	50.0% 3/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Alkaline phosphatase	66.7% 4/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Bicarbonate, serum-low	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypercalcemia	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypercholesteremia	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyperglycemia	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyperkalemia	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypernatremia	50.0% 3/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypertriglyceridemia	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypocalcemia	50.0% 3/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypoglycemia	66.7% 4/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypokalemia	100.0% 6/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypomagnesemia	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypophosphatemia	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Proteinuria	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGOT	50.0% 3/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGPT	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Uric acid, serum-high (hyperuricemia)	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Muscle Spasms)	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Confusion	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Dizziness	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Mood alteration	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Mood alteration: Agitation	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Somnolence/depressed level of consciousness	50.0% 3/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Pain: Abdomen NOS	66.7% 4/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Pain: Bladder	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Chest/thorax NOS	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Pain: Head/headache	50.0% 3/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Joint	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Muscle	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Neck	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Pain: Throat/pharynx/larynx	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	33.3% 2/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Hypoxia	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Renal/Genitourinary - Other	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Urinary frequency/urgency	16.7% 1/6 • 13 years, 5 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Flu-like syndrome	16.7% 1/6 • 13 years, 5 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