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

Sponsor

Wakayama Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00669292

Collaborator

Human Genome Center, Institute of Medical Science, University of Tokyo (Other)

Enrollment

Location

Study Details

Study Description

Brief 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.

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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.

Study Start Date :

Nov 1, 2006

Anticipated Primary Completion Date :

Nov 1, 2009

Outcome Measures

Primary Outcome Measures

Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) [2 months]

Secondary Outcome Measures

To evaluate immunological responses (Phase I/II) [2months]
To determine the recommended phase II dose of CpG7909(Phase I) [2months]
To determine the clinical effectiveness in the patients with measurable disease(Phase I) [2months]
To analyze the toxicity(Phase II) [2months]
Time to progression(Phase II) [5 years]
survival(Phase II) [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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