Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT00054912
Status:
COMPLETED
Last Update Posted:
2008-04-09
First Post:
2003-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'statusVerifiedDate': '2004-04', 'lastUpdateSubmitDate': '2008-04-07', 'studyFirstSubmitDate': '2003-02-12', 'studyFirstSubmitQcDate': '2003-02-13', 'lastUpdatePostDateStruct': {'date': '2008-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-02-14', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['vaccine', 'colon', 'cancer', 'colorectal', 'neoplasm', 'Colonic Cancer', 'Colon Cancer', 'Cancer of the Colon'], 'conditions': ['Colonic Neoplasms', 'Colorectal Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.idm-biotech.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Colon Cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of Colon Cancer, stage III\n* At least four weeks following prior standard treatment, with no evidence of disease\n* Must use adequate birth control\n\nExclusion Criteria:\n\n* Prior cancer vaccine therapy or concurrent participation in any other investigational study\n* A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment\n* A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine\n* Women who are pregnant, intend to become pregnant, or who are breast feeding'}, 'identificationModule': {'nctId': 'NCT00054912', 'briefTitle': 'An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epimmune'}, 'officialTitle': 'An Open Label, Multi-Center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage III Colon Cancer', 'orgStudyIdInfo': {'id': 'EP2101-102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EP2101', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Centers of Florida', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'New York Oncology Hematology', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Medical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cancer Center', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '91895', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99218', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Cancer Care Northwest', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epimmune', 'class': 'INDUSTRY'}}}}