Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155766
Status:
UNKNOWN
Last Update Posted:
2005-12-20
First Post:
2005-09-09
Brief Title:
Immunotherapy of Recurrent Cervical Cancers Using Dendritic Cells DCs
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Pilot Study for the Immunotherapy of Recurrent Cervical Cancers Using Dendritic Cells DCs Pulsed With Human Papillomavirus Type 16 E7 Antigen
Status:
UNKNOWN
Status Verified Date:
2002-06
Last Known Status:
RECRUITING
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:
Chemotherapy is the current standard treatment for unresectable recurrent cervical carcinoma after radiotherapy or distant metastasis of cervical carcinoma The most effective regimens are cisplatin-based chemotherapy After failure of the cisplatin-based chemotherapy there is still no treatment that has been proved to be effective
Human papilloma viruses HPV have been consistently implicated in causing cervical cancer especially those high-risk types HPV 16183145 have been strongly associated with cervical cancer HPV 16 was found in more than 50 of cervical cancer tissues Results from many animal tumor models have indicated that immunization with tumor antigen-pulsed dendritic cells can trigger a long-lasting anti-tumor immune response and significantly inhibit the growth of implanted tumor cells Recently many clinical trials have been conducted to evaluate the feasibility and safety of immunizing cancer patients with tumor antigen-pulsed dendritic cells No severe toxicity has been reported and some patients were shown to respond to the treatment Based on previous animal and clinical studies by other investigators we propose to evaluate the potential of immunizing cancer patients with antigen-pulsed autologous dendritic cells as a cancer vaccine to treat for recurrent cervical cancers after failure of cisplatin-based chemotherapy treatment or refusing chemotherapy In this study we will generate dendritic cells by culturing patients autologous PBMC with GM-CSF and IL-4 in vitro These dendritic cells will be pulsed with synthetic peptides representing the CTL epitopes on HPV Type 16 E7 Antigen-pulsed dendritic cells will be injected into inguinal lymph nodes under the guidance of real-time sonography Each patient will receive four injections and 12 patients in total will be recruited for this study
Human papilloma viruses HPV have been consistently implicated in causing cervical cancer especially those high-risk types HPV 16183145 have been strongly associated with cervical cancer HPV 16 was found in more than 50 of cervical cancer tissues Results from many animal tumor models have indicated that immunization with tumor antigen-pulsed dendritic cells can trigger a long-lasting anti-tumor immune response and significantly inhibit the growth of implanted tumor cells Recently many clinical trials have been conducted to evaluate the feasibility and safety of immunizing cancer patients with tumor antigen-pulsed dendritic cells No severe toxicity has been reported and some patients were shown to respond to the treatment Based on previous animal and clinical studies by other investigators we propose to evaluate the potential of immunizing cancer patients with antigen-pulsed autologous dendritic cells as a cancer vaccine to treat for recurrent cervical cancers after failure of cisplatin-based chemotherapy treatment or refusing chemotherapy In this study we will generate dendritic cells by culturing patients autologous PBMC with GM-CSF and IL-4 in vitro These dendritic cells will be pulsed with synthetic peptides representing the CTL epitopes on HPV Type 16 E7 Antigen-pulsed dendritic cells will be injected into inguinal lymph nodes under the guidance of real-time sonography Each patient will receive four injections and 12 patients in total will be recruited for this study
Detailed Description:
Chemotherapy is the current standard treatment for unresectable recurrent cervical carcinoma after radiotherapy or distant metastasis of cervical carcinoma The most effective regimens are cisplatin-based chemotherapy After failure of the cisplatin-based chemotherapy there is still no treatment that has been proved to be effective
Human papilloma viruses HPV have been consistently implicated in causing cervical cancer especially those high-risk types HPV 16183145 have been strongly associated with cervical cancer HPV 16 was found in more than 50 of cervical cancer tissues Results from many animal tumor models have indicated that immunization with tumor antigen-pulsed dendritic cells can trigger a long-lasting anti-tumor immune response and significantly inhibit the growth of implanted tumor cells Recently many clinical trials have been conducted to evaluate the feasibility and safety of immunizing cancer patients with tumor antigen-pulsed dendritic cells No severe toxicity has been reported and some patients were shown to respond to the treatment Based on previous animal and clinical studies by other investigators we propose to evaluate the potential of immunizing cancer patients with antigen-pulsed autologous dendritic cells as a cancer vaccine to treat for recurrent cervical cancers after failure of cisplatin-based chemotherapy treatment or refusing chemotherapy In this study we will generate dendritic cells by culturing patients autologous PBMC with GM-CSF and IL-4 in vitro These dendritic cells will be pulsed with synthetic peptides representing the CTL epitopes on HPV Type 16 E7 Antigen-pulsed dendritic cells will be injected into inguinal lymph nodes under the guidance of real-time sonography Each patient will receive four injections and 12 patients in total will be recruited for this study
Human papilloma viruses HPV have been consistently implicated in causing cervical cancer especially those high-risk types HPV 16183145 have been strongly associated with cervical cancer HPV 16 was found in more than 50 of cervical cancer tissues Results from many animal tumor models have indicated that immunization with tumor antigen-pulsed dendritic cells can trigger a long-lasting anti-tumor immune response and significantly inhibit the growth of implanted tumor cells Recently many clinical trials have been conducted to evaluate the feasibility and safety of immunizing cancer patients with tumor antigen-pulsed dendritic cells No severe toxicity has been reported and some patients were shown to respond to the treatment Based on previous animal and clinical studies by other investigators we propose to evaluate the potential of immunizing cancer patients with antigen-pulsed autologous dendritic cells as a cancer vaccine to treat for recurrent cervical cancers after failure of cisplatin-based chemotherapy treatment or refusing chemotherapy In this study we will generate dendritic cells by culturing patients autologous PBMC with GM-CSF and IL-4 in vitro These dendritic cells will be pulsed with synthetic peptides representing the CTL epitopes on HPV Type 16 E7 Antigen-pulsed dendritic cells will be injected into inguinal lymph nodes under the guidance of real-time sonography Each patient will receive four injections and 12 patients in total will be recruited 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