Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009841
Status:
COMPLETED
Last Update Posted:
2016-02-12
First Post:
2001-02-02
Brief Title:
Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Trial Of Intratumoral EGFR Antisense DNA And DC-Chol Liposomes In Advanced Oral Squamous Cell Carcinoma
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:
RATIONALE Gene therapy may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer
PURPOSE Phase I trial to study the effectiveness of gene therapy in treating patients who have advanced head and neck cancer
PURPOSE Phase I trial to study the effectiveness of gene therapy in treating patients who have advanced head and neck cancer
Detailed Description:
OBJECTIVES I Determine the safety and biological activity of EGFR antisense DNA and DC-chol liposomes in patients with advanced squamous cell carcinoma of the head and neck II Determine the toxicity and maximum tolerated dose of this regimen in these patients III Determine the antitumor response in patients treated with this regimen IV Determine the effect of this regimen on EGFR expression levels STAT protein expressionactivation levels and apoptosis rates in biopsied tumor cells of these patients
OUTLINE This is a dose-escalation study Patients receive EGFR antisense DNA and DC-chol liposomes intratumorally weekly for 4 weeks Courses repeat every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of EGFR antisense DNA and DC-chol liposomes until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity Patients are followed at 1 month
PROJECTED ACCRUAL A total of 20-36 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive EGFR antisense DNA and DC-chol liposomes intratumorally weekly for 4 weeks Courses repeat every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of EGFR antisense DNA and DC-chol liposomes until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity Patients are followed at 1 month
PROJECTED ACCRUAL A total of 20-36 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G00-1904 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068414 | REGISTRY | None | None |
| PCI-IRB-980771 | None | None | None |