Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003458
Status:
COMPLETED
Last Update Posted:
2022-03-07
First Post:
1999-11-01
Brief Title:
Antineoplaston Therapy in Treating Children With Brain Tumors
Sponsor:
Burzynski Research Institute
Organization:
Burzynski Research Institute
Study Overview
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 in Children With Brain Tumors
Status:
COMPLETED
Status Verified Date:
2022-03
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 childhood brain tumors provide limited benefit to the patient The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors
PURPOSE This study is being performed to determine the effects good and bad that Antineoplaston therapy has on children 6 months of age with brain tumors
PURPOSE This study is being performed to determine the effects good and bad that Antineoplaston therapy has on children 6 months of age with brain tumors
Detailed Description:
OVERVIEW This is a single arm open-label study in which children with brain tumors 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
OBJECTIVES
To determine the efficacy of Antineoplaston therapy in children with a brain tumor 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 children with a brain tumor
To determine objective response tumor size is measured utilizing MRI scans which are performed every 8 weeks for the first two years every 3 months for the third and fourth years every 6 months for the 5th and sixth years and annually thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued to this study
OBJECTIVES
To determine the efficacy of Antineoplaston therapy in children with a brain tumor 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 children with a brain tumor
To determine objective response tumor size is measured utilizing MRI scans which are performed every 8 weeks for the first two years every 3 months for the third and fourth years every 6 months for the 5th and sixth years and annually thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued to 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-10 | OTHER | Burzynski Research Institute Inc | None |