Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-28 @ 8:12 PM
Study NCT ID:
NCT00669292
Status:
UNKNOWN
Last Update Posted:
2010-09-09
First Post:
2008-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PhaseⅠ/Ⅱ Study of URLC10-177 and TTK-567 Peptide Vaccine Combined With CpG7909 in Patients With Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C483020', 'term': 'ProMune'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-09-08', 'studyFirstSubmitDate': '2008-04-28', 'studyFirstSubmitQcDate': '2008-04-29', 'lastUpdatePostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate immunological responses (Phase I/II)', 'timeFrame': '2months'}, {'measure': 'To determine the recommended phase II dose of CpG7909(Phase I)', 'timeFrame': '2months'}, {'measure': 'To determine the clinical effectiveness in the patients with measurable disease(Phase I)', 'timeFrame': '2months'}, {'measure': 'To analyze the toxicity(Phase II)', 'timeFrame': '2months'}, {'measure': 'Time to progression(Phase II)', 'timeFrame': '5 years'}, {'measure': 'survival(Phase II)', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['esophageal cancer', 'peptide', 'URLC10', 'TTK', 'CpG7909'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '20874827', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nphase 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDISEASE CHARACTERISTICS\n\n1. locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer\n2. measurable disease by CT scan\n\nPATIENT CHARACTERISTICS\n\n1. ECOG performance status 0-1\n2. Life expectancy \\> 3 months\n3. Laboratory values as follows\n\n * 2000/mm3 \\< WBC \\< 15000/mm3\n * Platelet count \\> 75000/mm3\n * Aspartate transaminase \\< 150 IU/L\n * Alanine transaminase \\< 150 IU/L\n * Creatinine \\< 2.0 mg/dl\n4. HLA-A\\*2402\n5. Able and willing to give valid written informed consent\n\nExclusion Criteria:\n\n1. Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)\n2. Breastfeeding\n3. Active or uncontrolled infection\n4. Concurrent treatment with steroids or immunosuppressing agent\n5. Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks\n6. Clinically significant heart disease\n7. Decision of unsuitableness by principal investigator or physician-in-charge'}, 'identificationModule': {'nctId': 'NCT00669292', 'briefTitle': 'PhaseⅠ/Ⅱ Study of URLC10-177 and TTK-567 Peptide Vaccine Combined With CpG7909 in Patients With Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wakayama Medical University'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'WEUTC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'URLC10-177, TTK-567, CpG-7909', 'type': 'BIOLOGICAL', 'description': 'peptide, peptide, TLR-9 agonist'}]}, 'contactsLocationsModule': {'locations': [{'city': '811-1 Kimiidera, Wakayama', 'state': 'Wakayama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Makoto Iwahashi, MD', 'role': 'CONTACT', 'email': 'makoto@wakayama-med.ac.jp', 'phone': '81-73-441-0613'}, {'name': 'Makoto Iwahashi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wakayama Medical University Hospital', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'centralContacts': [{'name': 'Makoto Iwahashi, MD', 'role': 'CONTACT', 'email': 'makoto@wakayama-med.ac.jp', 'phone': '81-73-441-0613'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wakayama Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Human Genome Center, Institute of Medical Science, University of Tokyo', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Second Department of Surgery', 'oldOrganization': 'Wakayama Medical University'}}}}