Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer (NCT NCT00003492)
NCT ID: NCT00003492
Last Updated: 2020-12-16
Results Overview
An objective response is a complete or partial response. A complete response is complete disappearance of all tumors by physical examination and radiographic studies for a minimum duration of four 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, 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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
16 months
Results posted on
2020-12-16
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 Stage IV Lung 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.
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|---|---|
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Overall Study
STARTED
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9
|
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Overall Study
COMPLETED
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3
|
|
Overall Study
NOT COMPLETED
|
6
|
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 Lung 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.
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|---|---|
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Overall Study
Not evaluable
|
6
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Baseline Characteristics
Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Baseline characteristics by cohort
| Measure |
Antineoplaston Therapy
n=9 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 Lung 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.
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|---|---|
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Age, Continuous
|
61.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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5 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 16 monthsPopulation: Evaluable participants
An objective response is a complete or partial response. A complete response is complete disappearance of all tumors by physical examination and radiographic studies for a minimum duration of four 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, 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.
Outcome measures
| Measure |
Antineoplaston Therapy
n=3 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 Lung 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.
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|---|---|
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Objective Response or Stable Disease
Stable Disease
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1 Participants
|
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Objective Response or Stable Disease
Progressive Disease
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2 Participants
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Adverse Events
Antineoplaston Therapy
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antineoplaston Therapy
n=9 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 Lung 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.
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|---|---|
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Blood and lymphatic system disorders
Hemoglobin
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
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Infections and infestations
Lung (pneumonia)
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
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|
Nervous system disorders
Neuropathy: motor
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
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Other adverse events
| Measure |
Antineoplaston Therapy
n=9 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 Lung 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.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
22.2%
2/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Blood and lymphatic system disorders
Platelets
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
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General disorders
Fatigue (asthenia, lethargy, malaise)
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
General disorders
Rigors/chills
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
General disorders
Edema/Fluid retention
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22.2%
2/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
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Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
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Gastrointestinal disorders
Nausea
|
44.4%
4/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
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Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Infections and infestations
Lung (pneumonia)
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
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Infections and infestations
Other
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
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Investigations
Albumin, serum-low (hypoalbuminemia)
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Investigations
Hyperglycemia
|
22.2%
2/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Investigations
Hypernatremia
|
66.7%
6/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Investigations
Hypokalemia
|
77.8%
7/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Nervous system disorders
Confusion
|
22.2%
2/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Nervous system disorders
Neuropathy: motor
|
11.1%
1/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
22.2%
2/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
General disorders
Pain: Head/headache
|
44.4%
4/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
33.3%
3/9 • 4 years, 8 months
Nine patients were recruited between April 1996 and November 2000. All study subjects were seen at the Burzynski Clinic in Houston TX.
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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