PhaseⅠ/Ⅱ Study of URLC10-177 and TTK-567 Peptide Vaccine Combined With CpG7909 in Patients With Esophageal Cancer
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.
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedSeptember 9, 2010
September 1, 2010
3 years
April 28, 2008
September 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
2 months
Secondary Outcomes (6)
To evaluate immunological responses (Phase I/II)
2months
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 analyze the toxicity(Phase II)
2months
Time to progression(Phase II)
5 years
- +1 more secondary outcomes
Interventions
peptide, peptide, TLR-9 agonist
Eligibility Criteria
You may qualify if:
- 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
- /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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wakayama Medical University Hospital
811-1 Kimiidera, Wakayama, Wakayama, Japan
Related Publications (1)
Iwahashi M, Katsuda M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Yamaue H. Vaccination with peptides derived from cancer-testis antigens in combination with CpG-7909 elicits strong specific CD8+ T cell response in patients with metastatic esophageal squamous cell carcinoma. Cancer Sci. 2010 Dec;101(12):2510-7. doi: 10.1111/j.1349-7006.2010.01732.x. Epub 2010 Sep 28.
PMID: 20874827DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 28, 2008
First Posted
April 30, 2008
Study Start
November 1, 2006
Primary Completion
November 1, 2009
Last Updated
September 9, 2010
Record last verified: 2010-09