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

Esophageal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00669292
• Other study ID #: WEUTC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 28, 2008
• Last updated: September 8, 2010
• Start date: November 2006

Study information

• Verified date: September 2010
• Source: Wakayama Medical University
• Contact: Makoto Iwahashi, MD
• Phone: 81-73-441-0613
• Email: makoto[@]wakayama-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Biological:
• URLC10-177, TTK-567, CpG-7909
peptide, peptide, TLR-9 agonist

Locations

Country	Name	City	State
Japan	Wakayama Medical University Hospital	811-1 Kimiidera, Wakayama	Wakayama

Sponsors (2)

Lead Sponsor	Collaborator
Wakayama Medical University	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)		2 months	Yes
Secondary	To evaluate immunological responses (Phase I/II)		2months	No
Secondary	To determine the recommended phase II dose of CpG7909(Phase I)		2months	Yes
Secondary	To determine the clinical effectiveness in the patients with measurable disease(Phase I)		2months	No
Secondary	To analyze the toxicity(Phase II)		2months	Yes
Secondary	Time to progression(Phase II)		5 years	No
Secondary	survival(Phase II)		5 years	No