Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Stage IV Melanoma (NCT NCT00003509)
NCT ID: NCT00003509
Last Updated: 2020-12-19
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
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
5 months
Results posted on
2020-12-19
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 Melanoma 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
|
13
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
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 Melanoma 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
|
5
|
Baseline Characteristics
Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Antineoplaston Therapy
n=13 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 Melanoma 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
|
44.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 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.
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 Stage IV Melanoma 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
Stable Disease
|
2 participants
|
|
Number of Participants With Objective Response
Progressive Disease
|
6 participants
|
Adverse Events
Antineoplaston Therapy
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antineoplaston Therapy
n=13 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 Melanoma 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.
|
|---|---|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus tachycardia
|
7.7%
1/13 • 8 years, 11 months
|
|
Cardiac disorders
Hypotension
|
7.7%
1/13 • 8 years, 11 months
|
|
Infections and infestations
Central Venous Catheter Infection
|
7.7%
1/13 • 8 years, 11 months
|
|
Blood and lymphatic system disorders
Hemorrhage-Other
|
7.7%
1/13 • 8 years, 11 months
|
|
Nervous system disorders
Seizure
|
7.7%
1/13 • 8 years, 11 months
|
Other adverse events
| Measure |
Antineoplaston Therapy
n=13 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 Melanoma 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)
|
15.4%
2/13 • 8 years, 11 months
|
|
General disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
7.7%
1/13 • 8 years, 11 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
23.1%
3/13 • 8 years, 11 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
7.7%
1/13 • 8 years, 11 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
15.4%
2/13 • 8 years, 11 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
15.4%
2/13 • 8 years, 11 months
|
|
Blood and lymphatic system disorders
Platelets
|
7.7%
1/13 • 8 years, 11 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus tachycardia
|
7.7%
1/13 • 8 years, 11 months
|
|
Cardiac disorders
Hypertension
|
7.7%
1/13 • 8 years, 11 months
|
|
Cardiac disorders
Hypotension
|
7.7%
1/13 • 8 years, 11 months
|
|
Infections and infestations
Central Venous Catheter
|
7.7%
1/13 • 8 years, 11 months
|
|
General disorders
Central Venous Catheter - Other
|
7.7%
1/13 • 8 years, 11 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
53.8%
7/13 • 8 years, 11 months
|
|
General disorders
Fever
|
23.1%
3/13 • 8 years, 11 months
|
|
General disorders
Insomnia
|
15.4%
2/13 • 8 years, 11 months
|
|
Skin and subcutaneous tissue disorders
Edema/Fluid retention
|
15.4%
2/13 • 8 years, 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • 8 years, 11 months
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
15.4%
2/13 • 8 years, 11 months
|
|
General disorders
Heartburn/dyspepsia
|
7.7%
1/13 • 8 years, 11 months
|
|
Gastrointestinal disorders
Nausea
|
61.5%
8/13 • 8 years, 11 months
|
|
Gastrointestinal disorders
Vomiting
|
46.2%
6/13 • 8 years, 11 months
|
|
Renal and urinary disorders
Hemorrhage, GU
|
7.7%
1/13 • 8 years, 11 months
|
|
Renal and urinary disorders
Hemorrhage, GU: Bladder
|
15.4%
2/13 • 8 years, 11 months
|
|
Blood and lymphatic system disorders
Hemorrhage-Other
|
7.7%
1/13 • 8 years, 11 months
|
|
Gastrointestinal disorders
Liver dysfunction/failure (clinical)
|
7.7%
1/13 • 8 years, 11 months
|
|
Infections and infestations
Infection - Other
|
7.7%
1/13 • 8 years, 11 months
|
|
Renal and urinary disorders
Infection (documented clinically): Bladder (urinary)
|
7.7%
1/13 • 8 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Mucosa
|
7.7%
1/13 • 8 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Sinus
|
7.7%
1/13 • 8 years, 11 months
|
|
Infections and infestations
Infection (documented clinically): Upper airway NOS
|
7.7%
1/13 • 8 years, 11 months
|
|
Infections and infestations
Lung (pneumonia)
|
7.7%
1/13 • 8 years, 11 months
|
|
Infections and infestations
Opportunistic infection
|
7.7%
1/13 • 8 years, 11 months
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
7.7%
1/13 • 8 years, 11 months
|
|
Investigations
Alkaline phosphatase
|
15.4%
2/13 • 8 years, 11 months
|
|
Investigations
Hyperbilirubinemia
|
7.7%
1/13 • 8 years, 11 months
|
|
Investigations
Hyperglycemia
|
46.2%
6/13 • 8 years, 11 months
|
|
Investigations
Hypernatremia
|
46.2%
6/13 • 8 years, 11 months
|
|
Investigations
Hypertriglyceridemia
|
7.7%
1/13 • 8 years, 11 months
|
|
Investigations
Hypocalcemia
|
7.7%
1/13 • 8 years, 11 months
|
|
Investigations
Hypoglycemia
|
15.4%
2/13 • 8 years, 11 months
|
|
Investigations
Hypokalemia
|
76.9%
10/13 • 8 years, 11 months
|
|
Nervous system disorders
Hyponatremia
|
15.4%
2/13 • 8 years, 11 months
|
|
Investigations
Hypophosphatemia
|
7.7%
1/13 • 8 years, 11 months
|
|
Investigations
SGOT
|
30.8%
4/13 • 8 years, 11 months
|
|
Investigations
SGPT
|
30.8%
4/13 • 8 years, 11 months
|
|
Nervous system disorders
Confusion
|
15.4%
2/13 • 8 years, 11 months
|
|
Nervous system disorders
Dizziness
|
23.1%
3/13 • 8 years, 11 months
|
|
Nervous system disorders
Mood alteration: Depression
|
7.7%
1/13 • 8 years, 11 months
|
|
Nervous system disorders
Neuropathy: sensory
|
7.7%
1/13 • 8 years, 11 months
|
|
Nervous system disorders
Seizure
|
30.8%
4/13 • 8 years, 11 months
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
23.1%
3/13 • 8 years, 11 months
|
|
Nervous system disorders
Speech impairment
|
15.4%
2/13 • 8 years, 11 months
|
|
Nervous system disorders
Syncope (fainting)
|
7.7%
1/13 • 8 years, 11 months
|
|
Eye disorders
Vision-blurred vision
|
7.7%
1/13 • 8 years, 11 months
|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
7.7%
1/13 • 8 years, 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
7.7%
1/13 • 8 years, 11 months
|
|
General disorders
Pain: Head/headache
|
46.2%
6/13 • 8 years, 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Joint
|
30.8%
4/13 • 8 years, 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Muscle
|
23.1%
3/13 • 8 years, 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
23.1%
3/13 • 8 years, 11 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
7.7%
1/13 • 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