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

Phase 1

• Conditions: Esophageal Cancer

• Registration Number: NCT00669292
• Lead Sponsor: Wakayama Medical University

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.

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 Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-04-28
• Study First Submitted QC: 2008-04-29
• Study First Posted: 2008-04-30
• Primary Completion: 2009-11
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-08
• Last Update Posted: 2010-09-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wakayama Medical University Hospital; 🇯🇵 811-1 Kimiidera, Wakayama, Wakayama, Japan