Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003588
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Brief Title:
Gene Therapy in Treating Patients With Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Ad-p53 NSC 683550 for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2002-06
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 in treating patients with ovarian cancer that has not responded to previous treatment Inserting the p53 gene into a persons cancer cells may improve the bodys ability to fight cancer or make the cancer cells more sensitive to treatment
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated doses of adenovirus p53 in patients with platinum- and paclitaxel-resistant ovarian epithelial cancer
II Determine the qualitative and quantitative toxic effects of this regimen in these patients
III Document the observed anti-tumor activity of this regimen in these patients
IV Evaluate the biological endpoints eg induction of apoptosis p53 expression of this regimen in these patients
OUTLINE This is a dose escalation study
Patients undergo laparoscopy for p53 assessment and catheter placement Patients receive daily intraperitoneal injections of adenovirus p53 Ad-p53 for 5 days every 3 weeks Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients each are treated at each dose level of Ad-p53 The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity
I Determine the maximum tolerated doses of adenovirus p53 in patients with platinum- and paclitaxel-resistant ovarian epithelial cancer
II Determine the qualitative and quantitative toxic effects of this regimen in these patients
III Document the observed anti-tumor activity of this regimen in these patients
IV Evaluate the biological endpoints eg induction of apoptosis p53 expression of this regimen in these patients
OUTLINE This is a dose escalation study
Patients undergo laparoscopy for p53 assessment and catheter placement Patients receive daily intraperitoneal injections of adenovirus p53 Ad-p53 for 5 days every 3 weeks Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients each are treated at each dose level of Ad-p53 The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity
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 |
|---|---|---|---|
| CDR0000066657 | REGISTRY | PDQ Physician Data Query | None |
| MDA-ID-97228 | None | None | None |
| NCI-T97-0111 | None | None | None |