Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus (NCT NCT00003487)
NCT ID: NCT00003487
Last Updated: 2021-05-14
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
59 months
Results posted on
2021-05-14
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 Adenocarcinoma of the Esophagus 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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8
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
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 Adenocarcinoma of the Esophagus 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
|
2
|
Baseline Characteristics
Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
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 Adenocarcinoma of the Esophagus 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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|---|---|
|
Age, Continuous
|
52.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 59 monthsPopulation: All patients enrolled in the study.
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.
Outcome measures
| 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 Adenocarcinoma of the Esophagus 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 Objective Response, Stable Disease, Progressive Disease or Not Evaluable
|
8 participants
|
Adverse Events
Antineoplaston Therapy
Serious events: 5 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 Adenocarcinoma of the Esophagus 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
|
12.5%
1/8 • 4 years, 11 months
|
|
Cardiac disorders
Hypotension
|
12.5%
1/8 • 4 years, 11 months
|
|
General disorders
Fatigue
|
12.5%
1/8 • 4 years, 11 months
|
|
General disorders
Fever
|
12.5%
1/8 • 4 years, 11 months
|
|
Gastrointestinal disorders
Hemorrhage: Gastrointestinal
|
50.0%
4/8 • 4 years, 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Infection: Pneumonia
|
12.5%
1/8 • 4 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 Adenocarcinoma of the Esophagus 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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|---|---|
|
General disorders
Allergic reaction/hypersensitivity (including drug fever)
|
12.5%
1/8 • 4 years, 11 months
|
|
Ear and labyrinth disorders
Hearing (without monitoring program)
|
12.5%
1/8 • 4 years, 11 months
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
1/8 • 4 years, 11 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
75.0%
6/8 • 4 years, 11 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
12.5%
1/8 • 4 years, 11 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
12.5%
1/8 • 4 years, 11 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
25.0%
2/8 • 4 years, 11 months
|
|
Cardiac disorders
Hypertension
|
12.5%
1/8 • 4 years, 11 months
|
|
Cardiac disorders
Hypotension
|
12.5%
1/8 • 4 years, 11 months
|
|
General disorders
Non-functional Central Venous Catheter
|
50.0%
4/8 • 4 years, 11 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
50.0%
4/8 • 4 years, 11 months
|
|
General disorders
Fever
|
50.0%
4/8 • 4 years, 11 months
|
|
General disorders
Rigors/chills
|
12.5%
1/8 • 4 years, 11 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
12.5%
1/8 • 4 years, 11 months
|
|
General disorders
Edema/Fluid retention
|
50.0%
4/8 • 4 years, 11 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • 4 years, 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
3/8 • 4 years, 11 months
|
|
Gastrointestinal disorders
Nausea
|
87.5%
7/8 • 4 years, 11 months
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • 4 years, 11 months
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
62.5%
5/8 • 4 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Abdomen NOS
|
12.5%
1/8 • 4 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Blood
|
12.5%
1/8 • 4 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Lung (pneumonia)
|
25.0%
2/8 • 4 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Small bowel NOS
|
12.5%
1/8 • 4 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Upper airway NOS
|
37.5%
3/8 • 4 years, 11 months
|
|
Infections and infestations
Opportunistic infection
|
50.0%
4/8 • 4 years, 11 months
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
37.5%
3/8 • 4 years, 11 months
|
|
Investigations
Alkaline phosphatase
|
37.5%
3/8 • 4 years, 11 months
|
|
Investigations
Hyperbilirubinemia
|
12.5%
1/8 • 4 years, 11 months
|
|
Investigations
Hyperglycemia
|
62.5%
5/8 • 4 years, 11 months
|
|
Investigations
Hyperkalemia
|
12.5%
1/8 • 4 years, 11 months
|
|
Investigations
Hypernatremia
|
50.0%
4/8 • 4 years, 11 months
|
|
Investigations
Hypocalcemia
|
62.5%
5/8 • 4 years, 11 months
|
|
Investigations
Hypoglycemia
|
25.0%
2/8 • 4 years, 11 months
|
|
Investigations
Hypokalemia
|
75.0%
6/8 • 4 years, 11 months
|
|
Investigations
Hypomagnesemia
|
12.5%
1/8 • 4 years, 11 months
|
|
Investigations
Metabolic/Laboratory - Other
|
12.5%
1/8 • 4 years, 11 months
|
|
Investigations
SGOT
|
25.0%
2/8 • 4 years, 11 months
|
|
Investigations
SGPT
|
25.0%
2/8 • 4 years, 11 months
|
|
Investigations
Uric acid, serum-high (hyperuricemia)
|
25.0%
2/8 • 4 years, 11 months
|
|
Nervous system disorders
Confusion
|
37.5%
3/8 • 4 years, 11 months
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • 4 years, 11 months
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
37.5%
3/8 • 4 years, 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
25.0%
2/8 • 4 years, 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Chest wall
|
12.5%
1/8 • 4 years, 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Extremity-limb
|
12.5%
1/8 • 4 years, 11 months
|
|
General disorders
Pain: Pain NOS
|
12.5%
1/8 • 4 years, 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
37.5%
3/8 • 4 years, 11 months
|
|
Infections and infestations
Flu-like illness
|
12.5%
1/8 • 4 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