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Trial Title:
Combination of Chemoradiation Therapy and Epitope Peptide Vaccine Therapy in Treating Patients With Esophageal Cancer
NCT ID:
NCT00632333
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Fluorouracil
Conditions: Keywords:
Epitope peptide
Vaccination
Chemoradiation
Esophageal cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil
Description:
Escalating dose of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified
with Montanide ISA51 will be administered by subcutaneous injection on days 15, 22, 28
and 35 of treatment cycle. Doses of each peptide are planning 0.5mg, 1mg and 3mg/body.
Chemotherapy plus radiation therapy will be done as follows: fluorouracil (400mg/m2) on
day1-5 and 8-12, cisplatin (40mg/m2) on days 1 and 8, radiation (2Gy) on days 1-5, 8-12
and 15-19. Two cycles of combination of chemoradiation therapy and epitope peptide
vaccine therapy will be done.
Arm group label:
1
Other name:
CDDP
Other name:
5-FU
Summary:
The purpose of this study is to evaluate the safety and immune response of multiple
peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 in
combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients
with unresectable, advanced or recurrent esophageal cancer.
Detailed description:
Up-regulated ling cancer 10 (URLC10), TTK protein kinase (TTK) and K homology domain
containing protein over expressed in cancer (KOC1) were identified as new targets of
tumor associated antigens using cDNA microarray technologies combined with the expression
profiles of normal and cancer tissues. Furthermore, anti-angiogenic therapy is now
considered to be one of promising approaches for treating cancer. Vascular endothelial
growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2
(VEGFR2) are essential targets for tumor angiogenesis. Epitope peptides for these targets
are able to induce cytotoxic T lymphocytes (CTL) restricted to HLA-A *2402 in vivo. On
the other hand, chemotherapy (CDDP, 5-FU) plus radiation therapy has been to be a
standard treatment for unresectable advanced esophageal cancer. In this clinical trial,
we evaluate the safety and immune responses of different doses of multiple peptides
(URLC10, TTK, KOC1, VEGFR1, and VEGFR 2) emulsified with Montanide ISA 51 in combination
with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with
unresectable, advanced or recurrent esophageal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must have unresectable, locally advanced, recurrent or metastatic disease
of esophageal cancer.
2. measurable disease by CT scan
3. ECOG performance status of 0 to 2
4. Expected survival of at lease 3months
5. Patients must be HLA-A2402
6. Laboratory values as follow:
- WBC > 2000/mm3,
- Platelet count > 75000/mm3,
- Total bilirubin < 1.5 x the institutional normal upper limits,
- Creatinine < 1.5 x the institutional normal upper limits,
- AST. ALT. ALP < 2.5 x the institutional normal upper limits
7. Able and willing to give valid written informed consent
Exclusion Criteria:
1. Pregnancy (women of childbearing potential:Refusal or inability to use effective
means of contraception)
2. Breastfeeding
3. Active or uncontrolled infection
4. Prior chemotherapy,radiation therapy or immunotherapy within 4 weeks
5. Concurrent treatment with steroid or immunosuppressing agent
6. Patient with peptic ulcer disease
7. Active or uncontrolled other malignancy
8. Other malignancy within 5 years prior to entry into the study, expect for treated
non-melanoma skin cancer and cervical carcinoma in situ
9. Disease to the central nervous system
10. Decision of unsuitableness by principal investigator or physician-in-charge
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Teikyo University
Address:
City:
2-11-1 Kaga Itabashi-ku
Zip:
173-0003
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Hisae Iinuma, PhD
Phone:
+81-33-964-1211
Email:
iinuma@med.teikyo-u.ac.jp
Investigator:
Last name:
Hisae Iinuma, PhD
Email:
Principal Investigator
Start date:
February 2008
Completion date:
March 2012
Lead sponsor:
Agency:
Teikyo University
Agency class:
Other
Collaborator:
Agency:
Human Genome Center, Institute of Medical Science, University of Tokyo
Agency class:
Other
Source:
Teikyo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00632333
