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.
20 Years
80 Years
Both
Esophageal Cancer
Trial Information
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 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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
Outcome Time Frame:
2 months
Safety Issue:
Yes
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
WEUTC
NCT ID:
NCT00669292
Start Date:
November 2006
Completion Date:
Related Keywords:
- Esophageal Cancer
- esophageal cancer
- peptide
- URLC10
- TTK
- CpG7909
- Esophageal Diseases
- Esophageal Neoplasms
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