Combination of Chemoradiation Therapy and Epitope Peptide Vaccine Therapy in Treating Patients With Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Teikyo University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Teikyo University
ClinicalTrials.gov Identifier:
NCT00632333
First received: February 29, 2008
Last updated: July 20, 2011
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Biological: URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Chemoradiation Therapy With Epitope Peptide Vaccine Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Teikyo University:

Primary Outcome Measures:
  • Safety(toxicities as assessed by NCI CTCAE version3) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peptide specific CTL induction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • DTH to peptide [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in levels of regulatory T cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Objective response rate as assessed by RECIST criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: February 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil
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.
Other Names:
  • CDDP
  • 5-FU

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632333

Contacts
Contact: Hisae Iinuma, PhD +81-33-964-1211 iinuma@med.teikyo-u.ac.jp

Locations
Japan
Teikyo University Recruiting
2-11-1 Kaga Itabashi-ku, Tokyo, Japan, 173-0003
Contact: Hisae Iinuma, PhD    +81-33-964-1211    iinuma@med.teikyo-u.ac.jp   
Principal Investigator: Hisae Iinuma, PhD         
Sponsors and Collaborators
Teikyo University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Kota Okinaga, MD, PhD Teikyo University , Department Surgery
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Surgery, Teikyo University
ClinicalTrials.gov Identifier: NCT00632333     History of Changes
Other Study ID Numbers: TPR07-079
Study First Received: February 29, 2008
Last Updated: July 20, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Teikyo University:
Epitope peptide
Vaccination
Chemoradiation
Esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014