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Immunotherapy of Recurrent Cervical Cancers Using Dendritic Cells (DCs)

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ClinicalTrials.gov Identifier: NCT00155766
Recruitment Status : Unknown
Verified June 2002 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : December 20, 2005
Sponsor:
Information provided by:

Study Description
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 16,18,31,45) 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 patient's 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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Biological: HPV16 E7 peptide-pulsed autologous DCs Phase 1

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 16,18,31,45) 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 patient's 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study for the Immunotherapy of Recurrent Cervical Cancers Using Dendritic Cells (DCs) Pulsed With Human Papillomavirus Type 16 E7 Antigen
Study Start Date : January 2003
Estimated Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 1. Safety issues in patients receiving HPV16 E7 peptide-pulsed autologous DCs immunotherapy

Secondary Outcome Measures :
  1. 1. Immunologic responses in patients receiving HPV16 E7 peptide-pulsed autologous DCs immunotherapy
  2. 2. Clinical response in patients receiving HPV16 E7 peptide-pulsed autologous DCs immunotherapy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. recurrent cervical cancer
  2. HPV 16 infection
  3. Previously received cisplatin ot 5-FU based chemotherapy or refused to receive chemotherapy
  4. HLA-A2 haplotype
  5. Older than 20 years old
  6. ECOG I or II
  7. Life expectancy longer than 3 months
  8. Adequate bone marrow reserve
  9. pregnancy test: negative
  10. Informed consent obtained

Exclusion Criteria:

  1. CNS metastasis
  2. Acute or chronic infection
  3. Pregnant or lactating women
  4. Asthma
  5. Cardiac diseases such as heart failure, unstable angina, arrhythmia, myocardial infarction
  6. Autoimmune disease
  7. Previously other cancers (except basal cell cancer)
  8. Without chemotherapy, biotherapy for more than 6 weeks
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155766


Contacts
Contact: Chi-An Chen, MD 886-2-2312-3456 ext 5157 cachen@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chi-An Chen, MD    886-2-2312-3456 ext 5157    cachen@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chi-An Chen, MD National Taiwan University Hospital
More Information

ClinicalTrials.gov Identifier: NCT00155766     History of Changes
Other Study ID Numbers: 9100205963
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 20, 2005
Last Verified: June 2002

Keywords provided by National Taiwan University Hospital:
cervical cancer, immunotherapy, DC

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female