Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003454
Status:
TERMINATED
Last Update Posted:
2017-09-28
First Post:
1999-11-01
Brief Title:
Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer
Sponsor:
Burzynski Research Institute
Organization:
Burzynski Research Institute
Study Overview
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Breast
Status:
TERMINATED
Status Verified Date:
2017-09
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 Antineoplastons are naturally-occurring substances that may also be made in the laboratory Antineoplastons may inhibit the growth of cancer cells
PURPOSE This phase II trial studies the effectiveness of antineoplaston therapy in treating women who have stage IV breast cancer that has not responded to previous therapy
PURPOSE This phase II trial studies the effectiveness of antineoplaston therapy in treating women who have stage IV breast cancer that has not responded to previous therapy
Detailed Description:
OVERVIEW This is a single arm open-label study in which patients with Stage IV breast cancer receive gradually escalating doses of intravenous Antineoplaston therapy Atengenal Astugenal until the maximum tolerated dose is reached Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity
OBJECTIVES
To determine the efficacy of Antineoplaston therapy in patients with Stage IV breast cancer 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 Stage IV breast cancer
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
OBJECTIVES
To determine the efficacy of Antineoplaston therapy in patients with Stage IV breast cancer 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 Stage IV breast cancer
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-BR-12 | OTHER | Burzynski Research Institute | None |