Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Multiple Myeloma (NCT NCT00003511)
NCT ID: NCT00003511
Last Updated: 2021-06-09
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
5 participants
Primary outcome timeframe
36 months
Results posted on
2021-06-09
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 Multiple Myeloma 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
|
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 Multiple Myeloma 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
|
4
|
Baseline Characteristics
Antineoplaston Therapy in Treating Patients With Multiple Myeloma
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 Multiple Myeloma 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
|
51.2 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: 36 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=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 Multiple Myeloma 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, Progressive Disease or Not Evaluable
Objective response
|
0 participants
|
|
Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable
Stable Disease
|
1 participants
|
|
Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable
Progressive Disease
|
0 participants
|
|
Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable
Not evaluable
|
4 participants
|
Adverse Events
Antineoplaston Therapy
Serious events: 4 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 Multiple Myeloma 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
Left ventricular systolic dysfunction
|
20.0%
1/5 • 3 years, 3 months
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
20.0%
1/5 • 3 years, 3 months
|
|
Infections and infestations
Infection (documented clinically): Lung (pneumonia)
|
40.0%
2/5 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Pelvis
|
20.0%
1/5 • 3 years, 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.0%
1/5 • 3 years, 3 months
|
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 Multiple Myeloma 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)
|
20.0%
1/5 • 3 years, 3 months
|
|
Ear and labyrinth disorders
Tinnitus
|
20.0%
1/5 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
60.0%
3/5 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
20.0%
1/5 • 3 years, 3 months
|
|
Blood and lymphatic system disorders
Platelets
|
60.0%
3/5 • 3 years, 3 months
|
|
Cardiac disorders
Hypertension
|
20.0%
1/5 • 3 years, 3 months
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
20.0%
1/5 • 3 years, 3 months
|
|
General disorders
Non-functional Central Venous Catheter
|
20.0%
1/5 • 3 years, 3 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
40.0%
2/5 • 3 years, 3 months
|
|
General disorders
Fever
|
20.0%
1/5 • 3 years, 3 months
|
|
General disorders
Weight gain
|
20.0%
1/5 • 3 years, 3 months
|
|
Skin and subcutaneous tissue disorders
Edema/Fluid retention
|
80.0%
4/5 • 3 years, 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • 3 years, 3 months
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
40.0%
2/5 • 3 years, 3 months
|
|
General disorders
Nausea
|
80.0%
4/5 • 3 years, 3 months
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • 3 years, 3 months
|
|
Renal and urinary disorders
Hemorrhage, GU
|
20.0%
1/5 • 3 years, 3 months
|
|
Renal and urinary disorders
Hemorrhage, GU: Bladder
|
40.0%
2/5 • 3 years, 3 months
|
|
Infections and infestations
Infection (documented clinically): Lung (pneumonia)
|
40.0%
2/5 • 3 years, 3 months
|
|
Infections and infestations
Infection (documented clinically): Upper airway NOS
|
20.0%
1/5 • 3 years, 3 months
|
|
Infections and infestations
Infection (documented clinically): Urinary tract NOS
|
20.0%
1/5 • 3 years, 3 months
|
|
Infections and infestations
Opportunistic infection
|
20.0%
1/5 • 3 years, 3 months
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
20.0%
1/5 • 3 years, 3 months
|
|
Infections and infestations
Alkaline phosphatase
|
20.0%
1/5 • 3 years, 3 months
|
|
Investigations
Hyperglycemia
|
20.0%
1/5 • 3 years, 3 months
|
|
Investigations
Hypernatremia
|
60.0%
3/5 • 3 years, 3 months
|
|
Investigations
Hypocalcemia
|
40.0%
2/5 • 3 years, 3 months
|
|
Investigations
Hypokalemia
|
40.0%
2/5 • 3 years, 3 months
|
|
Investigations
Hypomagnesemia
|
20.0%
1/5 • 3 years, 3 months
|
|
Investigations
SGOT
|
20.0%
1/5 • 3 years, 3 months
|
|
Investigations
Uric acid, serum-high (hyperuricemia)
|
40.0%
2/5 • 3 years, 3 months
|
|
Nervous system disorders
Confusion
|
20.0%
1/5 • 3 years, 3 months
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • 3 years, 3 months
|
|
Nervous system disorders
Neuropathy: motor
|
20.0%
1/5 • 3 years, 3 months
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
40.0%
2/5 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Chest wall
|
20.0%
1/5 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Extremity-limb
|
20.0%
1/5 • 3 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Pelvis
|
20.0%
1/5 • 3 years, 3 months
|
|
Reproductive system and breast disorders
Dyspnea (shortness of breath)
|
60.0%
3/5 • 3 years, 3 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