Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377247
Status:
TERMINATED
Last Update Posted:
2016-07-11
First Post:
2006-09-14
Brief Title:
Active Immunization of Patients With Carcinoma of Oral Cavity or Oropharynx With Autologous Dendritic Cells Transfected With DNA From Autologous Tumor
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Active Immunization of Patients With Carcinoma of Oral Cavity or Oropharynx With Autologous Dendritic Cells Transfected With DNA From Autologous Tumor Phase III Study
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study closed to accrual due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of this study is to determine if the vaccine can be safely given to subjects and to see what side effects occur both good and bad when they are given this experimental tumor vaccine During this study investigators intend to watch for tumor response while examining the effects of this vaccine on the bodys immune system after it is given
Detailed Description:
This is an uncontrolled non-randomized trial to evaluate safety immunogenicity and feasibility of a new vaccine consisting of autologous monocyte-derived dendritic cells DC transfected with autologous tumor-derived DNA Briefly the plan is to use a two-stage trial design and to initially enroll 17 patients with primary advanced carcinoma of the oral cavity or oropharynx over a period of 2 years The patients will undergo surgery and a portion of the primary tumor specimen not necessary for the pathologic diagnosis will be obtained to serve as a source of tumor DNA Each DC-based vaccine will contain DNA-transfected DC It will be administered intranodally under ultrasound guidance Only those patients who have normal delayed type hypersensitivity DTH responses to recall antigens will be eligible to receive the vaccine Immunologic response to the vaccine will be evaluated If there is no evidence of toxicity and 3 patients show immunologic response the second stage of the study will be opened for accrual of 22 patients All patients will be monitored by interferon- gamma IFN- secretion in enzyme-linked immunospot ELISPOT assays prior to and after vaccination for the frequency of T-cells responsive to autologous tumor and to the vaccine The patients will also be evaluated before and after vaccination for the capability of their T cells to respond to activating signals delivered via the T cell receptor TcR
Primary Objective To determine the safety and feasibility of immunization of patients with carcinoma of the oral cavity or oropharynx with autologous monocyte-derived dendritic cells DC transfected with DNA obtained from the patients own cancer cells
Secondary Objective To evaluate the ability of the DNA-based DC vaccine to induce immune responses to the vaccine as well as to autologous tumor
Primary Objective To determine the safety and feasibility of immunization of patients with carcinoma of the oral cavity or oropharynx with autologous monocyte-derived dendritic cells DC transfected with DNA obtained from the patients own cancer cells
Secondary Objective To evaluate the ability of the DNA-based DC vaccine to induce immune responses to the vaccine as well as to autologous tumor
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 |
|---|---|---|---|
| NIH R01-DE13818 | None | None | None |