Clinical Trial: Immunotherapy of Recurrent Cervical Cancers Using Dendritic Cells (DCs)

This study is currently recruiting patients.
Verified by National Taiwan University Hospital June 2002

Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00155766

Purpose

Chemotherapy is the current standard treatment for unresectable recurrent cervical carcinoma after radiotherapy or dsitant 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 Intervention Phase
Cervical Cancer
 Vaccine: HPV16 E7 peptide-pulsed autologous DCs
Phase I

MedlinePlus related topics:  Cervical Cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: A Pilot Study for the Immunotherapy of Recurrent Cervical Cancers Using Dendritic Cells (DCs) Pulsed with Human Papillomavirus Type 16 E7 Antigen

Further Study Details: 
Primary Outcomes: 1. Safety issues in patients receiving HPV16 E7 peptide-pulsed autologous DCs immunotherapy
Secondary Outcomes: 1. Immunologic responses in patients receiving HPV16 E7 peptide-pulsed autologous DCs immunotherapy; 2. Clinical response in patients receiving HPV16 E7 peptide-pulsed autologous DCs immunotherapy
Expected Total Enrollment:  12

Study start: January 2003;  Expected completion: March 2006
Last follow-up: March 2006;  Data entry closure: March 2006

Chemotherapy is the current standard treatment for unresectable recurrent cervical carcinoma after radiotherapy or dsitant 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.

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Female
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, arrythmia, myomardial infarction
  6. Autoimmune disease
  7. Previously other cancers (except basal cell cancer)
  8. Without chemotherapy, biotherapy for more than 6 weeks

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00155766

Chi-An Chen, MD      886-2-2312-3456  Ext. 5157    cachen@ha.mc.ntu.edu.tw

Taiwan
      National Taiwan University Hospital, Taipei,  Taiwan; Recruiting
Chi-An Chen, MD  886-2-2312-3456  Ext. 5157    cachen@ha.mc.ntu.edu.tw 

Study chairs or principal investigators

Chi-An Chen, MD,  Principal Investigator,  National Taiwan University Hospital   

More Information

Study ID Numbers:  9100205963
Last Updated:  September 9, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00155766
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13

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