Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma (NCT NCT00003498)
NCT ID: NCT00003498
Last Updated: 2021-01-22
Results Overview
An objective response is defined as a complete or partial response. A complete response is complete disappearance of all tumor by physical examination and radiographic studies and bone marrow involvement, if appropriate, for a minimum of four weeks. A partial response is a \> 50% reduction 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 four weeks. Stable disease indicates \< 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 twelve weeks. Progressive Disease is a \> 50% increase 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 four weeks.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
5 months
Results posted on
2021-01-22
Participant Flow
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 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.
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|---|---|
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Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
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 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.
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|---|---|
|
Overall Study
Not evaluable.
|
4
|
Baseline Characteristics
Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| 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 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
|
46.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsAn objective response is defined as a complete or partial response. A complete response is complete disappearance of all tumor by physical examination and radiographic studies and bone marrow involvement, if appropriate, for a minimum of four weeks. A partial response is a \> 50% reduction 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 four weeks. Stable disease indicates \< 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 twelve weeks. Progressive Disease is a \> 50% increase 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 four weeks.
Outcome measures
| Measure |
Antineoplaston Therapy
n=1 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 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.
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|---|---|
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Number of Participants With an Objective Response, Stable Disease, or Progressive Disease
Complete Response
|
0 participants
|
|
Number of Participants With an Objective Response, Stable Disease, or Progressive Disease
Partial Response
|
0 participants
|
|
Number of Participants With an Objective Response, Stable Disease, or Progressive Disease
Stable Disease
|
0 participants
|
|
Number of Participants With an Objective Response, Stable Disease, or Progressive Disease
Progressive Disease
|
1 participants
|
Adverse Events
Antineoplaston Therapy
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antineoplaston Therapy
n=5 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 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.
|
|---|---|
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Skin and subcutaneous tissue disorders
Hemorrhage/Bleeding - Other (Inguinal region)
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
Other adverse events
| Measure |
Antineoplaston Therapy
n=5 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 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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Blood and lymphatic system disorders
Hemoglobin
|
60.0%
3/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
40.0%
2/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Blood and lymphatic system disorders
Lymphopenia
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Blood and lymphatic system disorders
Platelets
|
40.0%
2/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Skin and subcutaneous tissue disorders
Edema/Fluid retention
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Renal and urinary disorders
Hemorrhage, GU: Bladder
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Skin and subcutaneous tissue disorders
Hemorrhage/Bleeding - Other (Inguinal region)
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Investigations
Alkaline phosphatase
|
40.0%
2/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Investigations
Hyperbilirubinemia
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Investigations
Hyperglycemia
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Investigations
Hypernatremia
|
40.0%
2/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Investigations
Hypocalcemia
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Investigations
Hypokalemia
|
100.0%
5/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Investigations
Hypomagnesemia
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Investigations
Proteinuria
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Investigations
SGOT
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
General disorders
Pain: Head/headache
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.0%
1/5 • 9 years, 4 months
Five patients were recruited between October 1997 and January 2007. 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