Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021424
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2001-07-11
Brief Title:
Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer
Sponsor:
National Institute on Deafness and Other Communication Disorders NIDCD
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IPilot Study of Intralesional Immunotherapy With A Recombinant Avipox Virus Engineered To Express A Triad Of Co-Stimulatory Molecules In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck
Status:
COMPLETED
Status Verified Date:
2002-08
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 Vaccines may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV head and neck cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxic effects of recombinant fowlpox-TRICOM vaccine in patients with advanced squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases
Determine the safety profile of this regimen in these patients
Determine the clinical activity of this regimen in terms of inflammation at injection sites and disease regression or stabilization in these patients
OUTLINE This is a dose-escalation study
Patients receive recombinant fowlpox-TRICOM vaccine rF-TRI intralesionally once on weeks 0 3 and 8 Beginning on week 16 patients may receive additional rF-TRI once every 8 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of rF-TRI until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 year
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine the maximum tolerated dose and dose-limiting toxic effects of recombinant fowlpox-TRICOM vaccine in patients with advanced squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases
Determine the safety profile of this regimen in these patients
Determine the clinical activity of this regimen in terms of inflammation at injection sites and disease regression or stabilization in these patients
OUTLINE This is a dose-escalation study
Patients receive recombinant fowlpox-TRICOM vaccine rF-TRI intralesionally once on weeks 0 3 and 8 Beginning on week 16 patients may receive additional rF-TRI once every 8 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of rF-TRI until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 year
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| NCI-3210 | None | None | None |
| NCI-01-DC-0006 | None | None | None |