Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma (NCT NCT00003499)

Last Updated: 2020-11-24

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

12 months

Results posted on

2020-11-24

Participant Flow

Thirty-one patients were recruited between March 1996 and November 2002. 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 Low-grade non-Hodgkin's lymphoma 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	31
Overall Study COMPLETED	23
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): Patients with Low-grade non-Hodgkin's lymphoma 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 Low-Grade Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antineoplaston Therapy n=31 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 Low-grade non-Hodgkin's lymphoma 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	54.2 Years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Antineoplaston Therapy n=23 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 Low-grade non-Hodgkin's lymphoma 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	2 Participants
Number of Participants With Objective Response Stable Disease	14 Participants
Number of Participants With Objective Response Progressive Disease	6 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=31 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 Low-grade non-Hodgkin's lymphoma 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 12 months overall survival	28 Percentage of Participants
Percentage of Participants Who Survived 24 months overall survival	21 Percentage of Participants
Percentage of Participants Who Survived 36 months overall survival	17 Percentage of Participants
Percentage of Participants Who Survived 48 months overall survival	14 Percentage of Participants
Percentage of Participants Who Survived 60 months overall survival	11 Percentage of Participants
Percentage of Participants Who Survived 6 months overall survival	29 Percentage of Participants

Adverse Events

Antineoplaston Therapy

Serious events: 10 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Antineoplaston Therapy n=31 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 Low-grade non-Hodgkin's lymphoma 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.
Blood and lymphatic system disorders Hemoglobin	3.2% 1/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Cardiac disorders Left ventricular systolic dysfunction	3.2% 1/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Blood	9.7% 3/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Lung (pneumonia)	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Seizure	3.2% 1/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Pain: Oral cavity	3.2% 1/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	3.2% 1/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing

Other adverse events

Other adverse events
Measure	Antineoplaston Therapy n=31 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 Low-grade non-Hodgkin's lymphoma 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)	32.3% 10/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Ear and labyrinth disorders Tinnitus	9.7% 3/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Hemoglobin	22.6% 7/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Leukocytes (total WBC)	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Lymphopenia	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	9.7% 3/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Blood and lymphatic system disorders Platelets	12.9% 4/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Cardiac disorders Cardiac Arrhythmia	16.1% 5/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Central venous catheter infection	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Central venous catheter - non-functional	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fatigue (asthenia, lethargy, malaise)	64.5% 20/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Fever	16.1% 5/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Rigors/chills	16.1% 5/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Skin and subcutaneous tissue disorders Hyperepidermisation	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
General disorders Edema	51.6% 16/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Diarrhea	25.8% 8/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Nausea	71.0% 22/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Taste alteration (dysgeusia)	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Gastrointestinal disorders Vomiting	32.3% 10/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Renal and urinary disorders Hemorrhage, GU	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Blood	19.4% 6/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Infection (documented clinically): Upper airway NOS	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Lung (pneumonia)	9.7% 3/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Mucosa	9.7% 3/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Skin	16.1% 5/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Infections and infestations Upper airway	25.8% 8/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Alkaline phosphatase	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyperbilirubinemia	9.7% 3/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hyperglycemia	16.1% 5/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypernatremia	71.0% 22/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypocalcemia	12.9% 4/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypochloremia	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypoglycemia	9.7% 3/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypokalemia	71.0% 22/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations Hypomagnesemia	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGOT	25.8% 8/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Investigations SGPT	12.9% 4/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Confusion	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Dizziness	29.0% 9/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Mood alteration	9.7% 3/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Neuropathy: sensory	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Somnolence/depressed level of consciousness	29.0% 9/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Speech impairment	6.5% 2/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Nervous system disorders Pain: Head/headache	32.3% 10/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Joint	29.0% 9/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Musculoskeletal and connective tissue disorders Pain: Muscle	9.7% 3/31 • 6 years, 8 months Adverse event data was collected through regular patient assessment and regular laboratory testing
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	29.0% 9/31 • 6 years, 8 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