Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin (NCT NCT00003526)
NCT ID: NCT00003526
Last Updated: 2020-12-17
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. Stable Disease (SD), \< 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
5 months
Results posted on
2020-12-17
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 Cancer of Unknown Primary Origin 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
|
8
|
|
Overall Study
COMPLETED
|
2
|
|
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 Cancer of Unknown Primary Origin 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
|
6
|
Baseline Characteristics
Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin
Baseline characteristics by cohort
| Measure |
Antineoplaston Therapy
n=8 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 Cancer of Unknown Primary Origin 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
|
61.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsObjective 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. Stable Disease (SD), \< 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.
Outcome measures
| Measure |
Antineoplaston Therapy
n=2 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 Cancer of Unknown Primary Origin 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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|---|---|
|
Number of Participants With Objective Response or Stable Disease
Stable Disease
|
1 participants
|
|
Number of Participants With Objective Response or Stable Disease
Progressive Disease
|
1 participants
|
Adverse Events
Antineoplaston Therapy
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antineoplaston Therapy
n=8 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 Cancer of Unknown Primary Origin 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
Hemorrhage, GI: Abdomen NOS
|
12.5%
1/8 • 8 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Lung (pneumonia)
|
12.5%
1/8 • 8 years, 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.5%
1/8 • 8 years, 11 months
|
Other adverse events
| Measure |
Antineoplaston Therapy
n=8 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 Cancer of Unknown Primary Origin 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)
|
12.5%
1/8 • 8 years, 11 months
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
1/8 • 8 years, 11 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
2/8 • 8 years, 11 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
1/8 • 8 years, 11 months
|
|
General disorders
Non-functional Central Venous Catheter
|
12.5%
1/8 • 8 years, 11 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
50.0%
4/8 • 8 years, 11 months
|
|
General disorders
Fever
|
25.0%
2/8 • 8 years, 11 months
|
|
Skin and subcutaneous tissue disorders
Edema/Fluid retention
|
50.0%
4/8 • 8 years, 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • 8 years, 11 months
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
12.5%
1/8 • 8 years, 11 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • 8 years, 11 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • 8 years, 11 months
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
25.0%
2/8 • 8 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Bladder (urinary)
|
12.5%
1/8 • 8 years, 11 months
|
|
Infections and infestations
Lung (pneumonia)
|
25.0%
2/8 • 8 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Upper airway NOS
|
12.5%
1/8 • 8 years, 11 months
|
|
Infections and infestations
Infection: Other
|
12.5%
1/8 • 8 years, 11 months
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
12.5%
1/8 • 8 years, 11 months
|
|
Investigations
Alkaline phosphatase
|
12.5%
1/8 • 8 years, 11 months
|
|
Investigations
Hyperbilirubinemia
|
12.5%
1/8 • 8 years, 11 months
|
|
Investigations
Hyperglycemia
|
37.5%
3/8 • 8 years, 11 months
|
|
Investigations
Hypernatremia
|
62.5%
5/8 • 8 years, 11 months
|
|
Investigations
Hypocalcemia
|
12.5%
1/8 • 8 years, 11 months
|
|
Investigations
Hypochloremia
|
12.5%
1/8 • 8 years, 11 months
|
|
Investigations
Hypoglycemia
|
12.5%
1/8 • 8 years, 11 months
|
|
Investigations
Hypokalemia
|
75.0%
6/8 • 8 years, 11 months
|
|
Infections and infestations
Hyponatremia
|
12.5%
1/8 • 8 years, 11 months
|
|
Investigations
Metabolic/Laboratory - Other
|
12.5%
1/8 • 8 years, 11 months
|
|
Investigations
SGOT
|
25.0%
2/8 • 8 years, 11 months
|
|
Investigations
SGPT
|
12.5%
1/8 • 8 years, 11 months
|
|
Nervous system disorders
Confusion
|
12.5%
1/8 • 8 years, 11 months
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • 8 years, 11 months
|
|
Nervous system disorders
Mood alteration
|
12.5%
1/8 • 8 years, 11 months
|
|
Nervous system disorders
Neuropathy: cranial: CN VII Motor-face; Sensory-taste
|
12.5%
1/8 • 8 years, 11 months
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • 8 years, 11 months
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
25.0%
2/8 • 8 years, 11 months
|
|
Nervous system disorders
Speech impairment
|
12.5%
1/8 • 8 years, 11 months
|
|
General disorders
Pain: Head/headache
|
25.0%
2/8 • 8 years, 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Joint
|
12.5%
1/8 • 8 years, 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • 8 years, 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
37.5%
3/8 • 8 years, 11 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
12.5%
1/8 • 8 years, 11 months
|
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