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Trial Title:
Immunotherapy of Recurrent Cervical Cancers Using Dendritic Cells (DCs)
NCT ID:
NCT00155766
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer, immunotherapy, DC
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
HPV16 E7 peptide-pulsed autologous DCs
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.
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chi-An Chen, MD
Phone:
886-2-2312-3456
Phone ext:
5157
Email:
cachen@ha.mc.ntu.edu.tw
Start date:
January 2003
Completion date:
March 2006
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00155766