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

  • STATUS
    Recruiting
  • participants needed
    29
  • sponsor
    Wakayama Medical University
Updated on 7 November 2020
ct scan
platelet count
cancer
measurable disease
esophageal cancer
peptide vaccine
metastatic esophageal cancer
recurrent esophageal cancer

Summary

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.

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.

Details
Condition Esophageal Cancer
Treatment URLC10-177, TTK-567, CpG-7909
Clinical Study IdentifierNCT00669292
SponsorWakayama Medical University
Last Modified on7 November 2020

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