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PhaseⅠ/Ⅱ Study of URLC10-177 and TTK-567 Peptide Vaccine Combined With CpG7909 in Patients With Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Wakayama Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00669292
First received: April 28, 2008
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

This is a single institution phase I / II trial to evaluate the safety and efficacy of URLC10-177 and TTK-567 emulsified with Montanide ISA 51 in combination with different doses of CpG7909 in patients with advanced or recurrent esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
Biological: URLC10-177, TTK-567, CpG-7909
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of URLC10-177 and TTK-567, Novel Tumor Specific Epitope Peptides Restricted to HLA-A*2402 Derived From Tumor Associated Antigens, Combined With CpG7909, a TLR9 Agonist, in Patients With Advanced or Recurrent Esophageal Cancer.

Resource links provided by NLM:


Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate immunological responses (Phase I/II) [ Time Frame: 2months ] [ Designated as safety issue: No ]
  • To determine the recommended phase II dose of CpG7909(Phase I) [ Time Frame: 2months ] [ Designated as safety issue: Yes ]
  • To determine the clinical effectiveness in the patients with measurable disease(Phase I) [ Time Frame: 2months ] [ Designated as safety issue: No ]
  • To analyze the toxicity(Phase II) [ Time Frame: 2months ] [ Designated as safety issue: Yes ]
  • Time to progression(Phase II) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • survival(Phase II) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 29
Study Start Date: November 2006
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: URLC10-177, TTK-567, CpG-7909
    peptide, peptide, TLR-9 agonist
Detailed Description:

phase I: Patients will be vaccinated on day 1,8,15 and 22 of each 28-day treatment cycles. On each vaccination day, the URLC10-117 peptide(1mg) and TTK-567 peptide(1mg) mixed with CpG 7909 (escalating doses: 0, 0.02, 0.1mg/kg) emulsified with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, or for maximum 2 cycles, whichever occurs first. In this phase I study, we evaluate the safety and tolerability of URLC10-177, TTK-567 and different doses of CpG7909 to determine the recommended phase II dose of CpG7909.

phase II: Patients will be vaccinated on day 1,8,15 and 22 of each 28-day treatment cycles. On each vaccination day, the URLC10-117 peptide(1mg) and TTK-567 peptide(1mg) mixed with CpG 7909 (recommended dose determined in phase I study) emulsified with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered for 2 cycles. In this phase II study, we evaluate the efficacy of this vaccine therapy.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS

  1. locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer
  2. measurable disease by CT scan

PATIENT CHARACTERISTICS

  1. ECOG performance status 0-1
  2. Life expectancy > 3 months
  3. Laboratory values as follows

    • 2000/mm3 < WBC < 15000/mm3
    • Platelet count > 75000/mm3
    • Aspartate transaminase < 150 IU/L
    • Alanine transaminase < 150 IU/L
    • Creatinine < 2.0 mg/dl
  4. HLA-A*2402
  5. Able and willing to give valid written informed consent

Exclusion Criteria:

  1. Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
  2. Breastfeeding
  3. Active or uncontrolled infection
  4. Concurrent treatment with steroids or immunosuppressing agent
  5. Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
  6. Clinically significant heart disease
  7. 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: NCT00669292

Contacts
Contact: Makoto Iwahashi, MD 81-73-441-0613 makoto@wakayama-med.ac.jp

Locations
Japan
Wakayama Medical University Hospital Recruiting
811-1 Kimiidera, Wakayama, Wakayama, Japan
Contact: Makoto Iwahashi, MD    81-73-441-0613    makoto@wakayama-med.ac.jp   
Principal Investigator: Makoto Iwahashi, MD         
Sponsors and Collaborators
Wakayama Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
  More Information

No publications provided by Wakayama Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00669292     History of Changes
Other Study ID Numbers: WEUTC
Study First Received: April 28, 2008
Last Updated: September 8, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Wakayama Medical University:
esophageal cancer
peptide
URLC10
TTK
CpG7909

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 24, 2014