Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT00044993
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2002-09-06
Is Possible Gene Therapy:
True
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
Sponsor:
Introgen Therapeutics
Organization:
Study Overview
Official Title:
Phase II, Single Arm, Single Institution Clinical Trial of Docetaxel and Doxorubicin in Combination With Local Administration of INGN 201 (Ad5CMV-p53) in Locally Advanced Breast Cancer (LABC)
Status:
COMPLETED
Status Verified Date:
2004-07
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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the p53 gene into the tumor may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. Combining chemotherapy with gene therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gene therapy in treating patients who have stage III or stage IV breast cancer.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gene therapy in treating patients who have stage III or stage IV breast cancer.
Detailed Description:
OBJECTIVES:
* Determine the therapeutic efficacy of docetaxel, doxorubicin, and Ad5CMV-p53 gene in patients with locally advanced breast cancer.
OUTLINE: Patients receive p53 gene by intralesional injection on days 1 and 2. Patients also receive doxorubicin IV over 15 minutes followed 1 hour later by docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses. After completion of chemotherapy, patients with a reasonable response undergo surgical resection.
PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.
* Determine the therapeutic efficacy of docetaxel, doxorubicin, and Ad5CMV-p53 gene in patients with locally advanced breast cancer.
OUTLINE: Patients receive p53 gene by intralesional injection on days 1 and 2. Patients also receive doxorubicin IV over 15 minutes followed 1 hour later by docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses. After completion of chemotherapy, patients with a reasonable response undergo surgical resection.
PROJECTED ACCRUAL: A maximum of 60 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?: