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

Phase 1
18 Years
75 Years
Open (Enrolling)
Cervical Cancer

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Trial Information

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

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.

Inclusion Criteria:

1. recurrent cervical cancer

2. HPV 16 infection

3. Previously received cisplatin ot 5-FU based chemotherapy or refused to receive

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

6. Autoimmune disease

7. Previously other cancers (except basal cell cancer)

8. Without chemotherapy, biotherapy for more than 6 weeks

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1. Safety issues in patients receiving HPV16 E7 peptide-pulsed autologous DCs immunotherapy

Principal Investigator

Chi-An Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

January 2003

Completion Date:

March 2006

Related Keywords:

  • Cervical Cancer
  • cervical cancer, immunotherapy, DC
  • Uterine Cervical Neoplasms