PhaseⅠ/Ⅱ Study of URLC10-177 and TTK-567 Peptide Vaccine Combined With CpG7909 in Patients With Esophageal Cancer
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Biological: URLC10-177, TTK-567, CpG-7909 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
- Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- To evaluate immunological responses (Phase I/II) [ Time Frame: 2months ] [ Designated as safety issue: No ]
- To determine the recommended phase II dose of CpG7909(Phase I) [ Time Frame: 2months ] [ Designated as safety issue: Yes ]
- To determine the clinical effectiveness in the patients with measurable disease(Phase I) [ Time Frame: 2months ] [ Designated as safety issue: No ]
- To analyze the toxicity(Phase II) [ Time Frame: 2months ] [ Designated as safety issue: Yes ]
- Time to progression(Phase II) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- survival(Phase II) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 29 |
| Study Start Date: | November 2006 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
-
Biological: URLC10-177, TTK-567, CpG-7909
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Makoto Iwahashi, MD | 81-73-441-0613 | makoto@wakayama-med.ac.jp |
| Japan | |
| Wakayama Medical University Hospital | Recruiting |
| 811-1 Kimiidera, Wakayama, Wakayama, Japan | |
| Contact: Makoto Iwahashi, MD 81-73-441-0613 makoto@wakayama-med.ac.jp | |
| Principal Investigator: Makoto Iwahashi, MD | |
More Information
No publications provided by Wakayama Medical University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Second Department of Surgery, Wakayama Medical University |
| ClinicalTrials.gov Identifier: | NCT00669292 History of Changes |
| Other Study ID Numbers: | WEUTC |
| Study First Received: | April 28, 2008 |
| Last Updated: | September 8, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Wakayama Medical University:
|
esophageal cancer peptide URLC10 TTK CpG7909 |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013