Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004038
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
1999-12-10
Brief Title:
Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Study of p53 Intralesional Gene Therapy With Chemotherapy in Breast Cancer
Status:
COMPLETED
Status Verified Date:
2001-06
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:
Phase I trial to study the effectiveness of gene therapy plus chemotherapy in treating patients who have breast cancer Inserting the p53 gene into a persons cancer cells may improve the bodys ability to fight cancer or make the cancer more sensitive to chemotherapy Combining chemotherapy with gene therapy may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the effect of adenovirus p53 Ad-p53 on chemotherapy-induced apoptosis in lesions in patients with breast cancer
II Determine p53 protein expression following intralesional injections of Ad-p53 by immunohistochemistry and reverse transcriptase polymerase chain reaction in this patient population
III Determine the time course and magnitude of the development of a humoral antibody response to the adenoviral vector in this patient population
IV Determine the ability of transfected p53 to upregulate downstream signals important in G1 arrest by assaying for WAF1 mRNA and apoptosis in this patient population
V Determine the toxicities and side effects of intralesional injections of Ad-p53 given in combination with standard chemotherapy in patients with cutaneous and subcutaneous metastatic breast cancer amenable to injections and biopsies
VI Determine if there is an increase in apoptosis induced by Ad-53 compared to baseline in this patient population
OUTLINE
Patients undergo biopsy of one of their skin nodules prior to any treatment Patients receive the Ad-p53 gene therapy in one nodule and injection of a second nodule with Dulbeccos phosphate buffered saline The next day patients begin chemotherapy which may be given weekly and continues every 21-28 days for up to 6 courses On day 3 patients return for biopsy of injected nodules Biopsies are only performed during the first course Patients may receive further injections of the Ad-p53 gene with subsequent courses of chemotherapy for up to six courses
Patients are followed monthly for 4 months
I Determine the effect of adenovirus p53 Ad-p53 on chemotherapy-induced apoptosis in lesions in patients with breast cancer
II Determine p53 protein expression following intralesional injections of Ad-p53 by immunohistochemistry and reverse transcriptase polymerase chain reaction in this patient population
III Determine the time course and magnitude of the development of a humoral antibody response to the adenoviral vector in this patient population
IV Determine the ability of transfected p53 to upregulate downstream signals important in G1 arrest by assaying for WAF1 mRNA and apoptosis in this patient population
V Determine the toxicities and side effects of intralesional injections of Ad-p53 given in combination with standard chemotherapy in patients with cutaneous and subcutaneous metastatic breast cancer amenable to injections and biopsies
VI Determine if there is an increase in apoptosis induced by Ad-53 compared to baseline in this patient population
OUTLINE
Patients undergo biopsy of one of their skin nodules prior to any treatment Patients receive the Ad-p53 gene therapy in one nodule and injection of a second nodule with Dulbeccos phosphate buffered saline The next day patients begin chemotherapy which may be given weekly and continues every 21-28 days for up to 6 courses On day 3 patients return for biopsy of injected nodules Biopsies are only performed during the first course Patients may receive further injections of the Ad-p53 gene with subsequent courses of chemotherapy for up to six courses
Patients are followed monthly for 4 months
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 |
|---|---|---|---|
| CDR0000066480 | REGISTRY | PDQ Physician Data Query | None |
| FCCC-97009 | None | None | None |
| NCI-T97-0042 | None | None | None |