Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003476
Status:
TERMINATED
Last Update Posted:
2017-08-24
First Post:
1999-11-01
Brief Title:
Antineoplaston Therapy in Treating Children With Primary Malignant 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 Primary Malignant Brain Tumors
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
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 children with primary malignant 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 children with primary malignant brain tumors
PURPOSE This study is being performed to determine the effects good and bad that Antineoplaston therapy has on children with primary malignant brain tumors
PURPOSE This study is being performed to determine the effects good and bad that Antineoplaston therapy has on children with primary malignant brain tumors
Detailed Description:
OBJECTIVES
To determine the efficacy of Antineoplaston therapy in children with primary malignant brain tumors 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 primary malignant brain tumors
OVERVIEW This is a single arm open-label study in which children with primary malignant 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 After 12 months patients with a complete or partial response or with stable disease may continue treatment
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
To determine the efficacy of Antineoplaston therapy in children with primary malignant brain tumors 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 primary malignant brain tumors
OVERVIEW This is a single arm open-label study in which children with primary malignant 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 After 12 months patients with a complete or partial response or with stable disease may continue treatment
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-22 | OTHER | Burzynski Research Institute Inc | None |