Trial Outcomes & Findings for Antineoplaston Therapy in Treating Patients With Meningioma (NCT NCT00003483)
NCT ID: NCT00003483
Last Updated: 2017-08-24
Results Overview
Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: 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 enhancing lesions, sustained for at least four weeks; Stable Disease (SD), \<50% decrease and \<25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
12 months
Results posted on
2017-08-24
Participant Flow
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
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): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).
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|---|---|
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Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
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): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).
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|---|---|
|
Overall Study
Not evaluable
|
1
|
Baseline Characteristics
Antineoplaston Therapy in Treating Patients With Meningioma
Baseline characteristics by cohort
| 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): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).
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|---|---|
|
Age, Continuous
|
41.8 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsObjective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: 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 enhancing lesions, sustained for at least four weeks; Stable Disease (SD), \<50% decrease and \<25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
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): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).
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|---|---|
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Number of Participants With Objective Response
Stable Disease
|
2 Participants
|
|
Number of Participants With Objective Response
Objective Response
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 24 monthsPopulation: All study subjects receiving any Antineoplaston therapy
6 months, 12 months, 24 months overall survival
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): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).
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|---|---|
|
Percentage of Participants Who Survived
6 months overall survival
|
66.7 Percentage of Participants
|
|
Percentage of Participants Who Survived
12 months overall survival
|
33.3 Percentage of Participants
|
|
Percentage of Participants Who Survived
24 months overall survival
|
33.3 Percentage of Participants
|
Adverse Events
Antineoplaston Therapy
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antineoplaston Therapy
n=3 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): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Infections and infestations
Infection (documented clinically): Skin (cellulitis)
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Nervous system disorders
Confusion
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Nervous system disorders
Pain: Head/headache
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
Other adverse events
| Measure |
Antineoplaston Therapy
n=3 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): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
66.7%
2/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Infections and infestations
Central Venous Catheter Infection
|
66.7%
2/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
66.7%
2/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
General disorders
Weight gain
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
General disorders
Edema/Fluid retention
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Infections and infestations
Infection (documented clinically): Mucosa
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Infections and infestations
Infection (documented clinically): Skin (cellulitis)
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Infections and infestations
Infection (documented clinically): Upper airway NOS
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
|
Infections and infestations
Opportunistic infection
|
33.3%
1/3 • 7 years, 9 months
Three patients were recruited between June 1996 and March 2004. All study subjects were seen at the Burzynski Clinic in Houston TX
|
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