Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003455
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Brief Title:
Antineoplaston Therapy in Treating Women With Advanced Breast Cancer
Sponsor:
Burzynski Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Oral Antineoplastons A10 and AS2-1 in Women With Advanced Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2006-12
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 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 is studying how well antineoplaston therapy works in treating women with stage IV breast cancer that has not responded to standard therapy
PURPOSE This phase II trial is studying how well antineoplaston therapy works in treating women with stage IV breast cancer that has not responded to standard therapy
Detailed Description:
OBJECTIVES
Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in patients with advanced breast cancer by determining the proportion of women who experience an objective tumor response
Evaluate the adverse effects of and tolerance to this regimen in these patients
OUTLINE This is an open-label study
Patients receive oral antineoplaston A10 and antineoplaston AS2-1 6 to 7 times per day
Treatment continues for at least 6 weeks Patients achieving complete or partial response may continue on therapy until disease progression or toxic effects occur
Patients are followed for survival
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in patients with advanced breast cancer by determining the proportion of women who experience an objective tumor response
Evaluate the adverse effects of and tolerance to this regimen in these patients
OUTLINE This is an open-label study
Patients receive oral antineoplaston A10 and antineoplaston AS2-1 6 to 7 times per day
Treatment continues for at least 6 weeks Patients achieving complete or partial response may continue on therapy until disease progression or toxic effects occur
Patients are followed for survival
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066487 | REGISTRY | PDQ Physician Data Query | None |