Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003459
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
1999-11-01
Brief Title:
Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
Sponsor:
Burzynski Research Institute
Organization:
Burzynski Research Institute
Study Overview
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Brain Stem Glioma
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Current therapies for a brain stem glioma provide very limited benefit to the patient The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain stem gliomas
PURPOSE This study is being performed to determine the effects good and bad that Antineoplaston therapy has on children 6 months of age and adults with newly-diagnosed or recurrent brain stem gliomas
PURPOSE This study is being performed to determine the effects good and bad that Antineoplaston therapy has on children 6 months of age and adults with newly-diagnosed or recurrent brain stem gliomas
Detailed Description:
OBJECTIVES
To determine the efficacy of Antineoplaston therapy in patients with a brain stem glioma as measured by an objective response to therapy complete response partial response or stable disease
To determine the safety and tolerance of Antineoplaston therapy in patients with a brain stem glioma
OVERVIEW This is a single arm open-label study in which patients receive gradually escalating doses of intravenous Antineoplaston therapy Atengenal Astugenal until the maximum tolerated dose is reached Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity After 12 months patients with a complete or partial response or with stable disease may continue treatment
To determine objective response tumor size in measured utilizing MRI scans which are performed every 8 weeks for the first 2 years every 3 months for the 3rd and 4th years every 6 months for the 5th and 6th years and annually thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
To determine the efficacy of Antineoplaston therapy in patients with a brain stem glioma as measured by an objective response to therapy complete response partial response or stable disease
To determine the safety and tolerance of Antineoplaston therapy in patients with a brain stem glioma
OVERVIEW This is a single arm open-label study in which patients receive gradually escalating doses of intravenous Antineoplaston therapy Atengenal Astugenal until the maximum tolerated dose is reached Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity After 12 months patients with a complete or partial response or with stable disease may continue treatment
To determine objective response tumor size in measured utilizing MRI scans which are performed every 8 weeks for the first 2 years every 3 months for the 3rd and 4th years every 6 months for the 5th and 6th years and annually thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BC-BT-11 | OTHER | Burzynski Research Institute Inc | None |