Trial | NCT00669292  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    29
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.
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.
Study Started
Nov 30
2006
Primary Completion
Nov 30
2009
Anticipated
Last Update
Sep 09
2010
Estimate

Biological URLC10-177, TTK-567, CpG-7909

peptide, peptide, TLR-9 agonist

Criteria 

Inclusion Criteria:

DISEASE CHARACTERISTICS

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

PATIENT CHARACTERISTICS

ECOG performance status 0-1
Life expectancy > 3 months

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
HLA-A*2402
Able and willing to give valid written informed consent

Exclusion Criteria:

Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
Breastfeeding
Active or uncontrolled infection
Concurrent treatment with steroids or immunosuppressing agent
Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
Clinically significant heart disease
Decision of unsuitableness by principal investigator or physician-in-charge
No Results Posted