Esophageal Cancer
Conditions
Keywords
esophageal cancer, peptide, URLC10, TTK, CpG7909
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.
Interventions
BIOLOGICALURLC10-177, TTK-567, CpG-7909
peptide, peptide, TLR-9 agonist
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
Wakayama Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 evaluate immunological responses (Phase I/II) | 2months |
| Time to progression(Phase II) | 5 years |
| survival(Phase II) | 5 years |
| To analyze the toxicity(Phase II) | 2months |
Countries
Japan
Contacts
Primary ContactMakoto Iwahashi, MD
Outcome results
None listed