Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-05 @ 6:05 PM
Study NCT ID:
NCT01671592
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2012-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Labeled Dendritic Cell (DC) Vaccines and Feasibility of Tracking by Magnetic Resonance Imaging (MRI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], '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'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706173', 'term': 'lentiviral minigene vaccine of COVID-19 coronavirus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-25', 'studyFirstSubmitDate': '2012-08-20', 'studyFirstSubmitQcDate': '2012-08-22', 'lastUpdatePostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events from the labeled DC vaccine', 'timeFrame': '1 year'}, {'measure': 'Ability to track the labeled DC vaccine by MRI', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Comparative analysis of the effectiveness of lymph node accumulation of DC vaccines injected to resting versus pre-activated nodes (DCs injected on day 1 versus day 3 of the three day-long vaccination cycle.', 'timeFrame': '1 year', 'description': 'Effectiveness of DC accumulation may be correlated with their effectiveness in inducing immune responses as measured by:\n\n* Increase in the magnitude in the DTH response to: A) autologous tumor lysates (primary endpoint of efficacy); B) KLH; and c) saline (control); all injected intradermally.\n* Peripheral blood CD8+ and CD4+ T cell responses against autologous tumor cells, using IFNγ-ELISPOT readout.\n* In any HLA-A2+ subjects on the protocol, we may evaluate peripheral blood CD8+ T cell responses against CRC-related peptide epitopes present, using IFN ELISPOT as readout.'}, {'measure': 'May assess the disease-free survival and overall survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer', 'colorectal', 'tumor', 'neoplasms', 'carcinoma', 'vaccine'], 'conditions': ['Colorectal Neoplasms', 'Colorectal Cancer', 'Colorectal Carcinoma', 'Colorectal Tumors', 'Neoplasms, Colorectal']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and feasibility MRI tracking of a vaccine produced from a persons cancer cells injected intradermally once a day for 3 consecutive days. One of the daily doses will contain a chemical that can be detected by an MRI. That will be either the 1st or 3rd day of the 3 day course. On that day MRI scans will be performed 6 and 24 hours after the injection on that day. Patients may be able to receive booster doses every 1-2 months', 'detailedDescription': 'STUDY EVALUATIONS\n\n* Pre-Vaccination\n\n * Complete physical examination (with ECOG performance status (PS), medical history, weight, height, and BSA); the exact size and location of all tumor lesions will be noted in the flow sheet, documented in the text note, and by photographic and/or radiologic means\n * CEA levels in the blood (as a tumor marker)\n * Women of childbearing potential will have a serum beta-HCG pregnancy test\n * Anti-HIV, HbsAg and Anti-HCV\n * CBC, platelet, differential\n * Comprehensive metabolic panel (CMP) including: glucose, BUN, creatinine, sodium, potassium, Cl, CO2, calcium, total protein, albumin, alkaline phosphatase, AST, ALT, total bilirubin\n * PT/PTT testing\n * Electrocardiogram (EKG), if indicated\n * Radiologic imaging to evaluate the status of disease may be performed as a part of routine care.\n * Leukapheresis\n * Dendritic cell vaccine preparation\n* Procedures during priming vaccination (Days 1 to 3)\n\n * Complete physical examination (with PS and weight)\n * 19F/1H MRI scanning on day of vaccination, 6 hrs (±1 hour) and 24 hrs (±4 hour) post-injection.\n * Blood for in vitro assays, before first i.d. administration on day 1 (baseline) and after the last i.d. administration on day 3\n * DTH tests: administration on day 1 and readout on day 3\n * Biopsy of the DTH site can be performed in any subject who consented to such biopsy, at the discretion of the investigator/sub-investigator (Day 3 only, based on readout)\n* Procedures on Day 15\n\n * Complete physical examination (with ECOG PS and weight)\n * CBC, platelet, differential\n * Blood for in vitro assays\n* Procedures during booster courses (Days 36 to 38, 64 to 66, and 91 to 93)\n\n * Complete physical examination (with PS and weight) on the 1st day of each 3 day course (Days 36, 64, and 91)\n * CBC, platelet, differential on the 1st day of each 3 day course (Days 36, 64, and 91)\n * Comprehensive metabolic panel (CMP) including: glucose, BUN, creatinine, sodium, potassium, Cl, CO2, calcium, total protein, albumin, alkaline phosphatase, AST, ALT, total bilirubin on the 1st day of each 3 day course (Days 36, 64, and 91)\n * DTH tests: administration on 1st day and readout on 3rd day during 2nd and 3rd booster courses (Administration days 64 and 91, readout days 66 and 93)\n * Biopsy of the DTH site can be performed in any subject who consented to such biopsy, at the discretion of the investigator/sub-investigator (3rd day of 3 day course, based on readout of DTH test)\n * Blood for in vitro assays (1st and 3rd day of each 3 day course)\n* Procedures on Day 105\n\n * Complete physical examination (with ECOG PS and weight)\n * CEA levels in the blood (as a tumor marker)\n * CBC, platelet, differential\n * Comprehensive metabolic panel (CMP) including: glucose, BUN, creatinine, sodium, potassium, Cl, CO2, calcium, total protein, albumin, alkaline phosphatase, AST, ALT, total bilirubin\n * Radiologic imaging to evaluate the status of disease may be performed as a part of routine care\n * Photography\n* Long term follow-up The subjects with lack of disease progression at 6 months after the last vaccination will be monitored for the disease free survival and overall survival. Subjects may be contacted every 3 months within the first three years after study intervention, every six months until year 5, and annually afterwards. In lieu of direct contact a medical record review may be performed to obtain the data for these time points for disease progression and/or survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have adequate tumor tissue from surgery, performed as part of their conventional care.\n* No chemotherapy, radiotherapy, major surgery, or biologic therapy for their malignancy in the 2 weeks prior to vaccine administration and they must have recovered from all side effects.\n* An ECOG performance status of 0, 1, or 2.\n* Age equal to 18 years or older.\n* Blood tests:\n\n * Platelet counts greater than 80,000 (platelet count, hematocrit, and WBC will be re-evaluated within 2 weeks prior to leukapheresis)\n * Hematocrit \\> 27.0\n * White blood count \\> 2000/µL\n * Creatinine less than or equal to 2 X ULN\n* Aware of the neoplastic nature of his/her illness, the experimental nature of the study intervention, alternative treatments, potential benefits and risks, and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Subjects currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 2 weeks after removal from immunosuppressive treatment. Subjects on maintenance steroids because of adrenal insufficiency are eligible.\n* Subjects with total bilirubin greater than 2 X ULN.\n* Subjects with uncontrolled pain.\n* Subjects with active autoimmune disease, positive serology for HIV, HBV, or HCV. (Hypothyroidism is allowed.)\n* Subjects who are allergic to or develop an allergy to heparin.\n* Subjects who are pregnant.\n* Subjects who have sensitivity to drugs that provide local anesthesia.\n* Subjects who have medical contraindications for MRI. Such contraindications include:\n\n * Electrical implants such as cardiac pacemakers or perfusion pumps\n * Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye or steel implants\n * Ferromagnetic objects such as jewelry or metal clips in clothing\n * Pre-existing medical conditions, including claustrophobic reactions, the likelihood of developing a seizure or any greater than normal potential for cardiac arrest'}, 'identificationModule': {'nctId': 'NCT01671592', 'briefTitle': 'Safety of Labeled Dendritic Cell (DC) Vaccines and Feasibility of Tracking by Magnetic Resonance Imaging (MRI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Safety and Feasibility Evaluation of the MRI-based Tracking of Alpha-type-1 Dendritic Cell Vaccines in Patients With Colorectal Cancer', 'orgStudyIdInfo': {'id': '10-052'}, 'secondaryIdInfos': [{'id': 'R01CA134633', 'link': 'https://reporter.nih.gov/quickSearch/R01CA134633', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Day 1 MRI with low dose vaccine', 'description': 'DC vaccine at 3 x 10e6 per course which consists of 3 daily intradermal doses per course with the MRI on day 1 of the course.', 'interventionNames': ['Biological: DC Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Day 3 MRI with low dose vaccine', 'description': 'DC vaccine at 3 x 10e6 per course which consists of 3 daily intradermal doses per course with the MRI on day 3 of the course.', 'interventionNames': ['Biological: DC Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Day 1 MRI with high dose vaccine', 'description': 'DC vaccine at 3 x 10e7 per course which consists of 3 daily intradermal doses per course with the MRI on day 1 of the course.', 'interventionNames': ['Biological: DC Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Day 3 MRI with high dose vaccine', 'description': 'DC vaccine at 3 x 10e7 per course which consists of 3 daily intradermal doses per course with the MRI on day 3 of the course.', 'interventionNames': ['Biological: DC Vaccine']}], 'interventions': [{'name': 'DC Vaccine', 'type': 'BIOLOGICAL', 'description': 'Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.', 'armGroupLabels': ['Day 1 MRI with high dose vaccine', 'Day 1 MRI with low dose vaccine', 'Day 3 MRI with high dose vaccine', 'Day 3 MRI with low dose vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'David L. Bartlett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pawel Kalinski', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Pawel Kalinski', 'investigatorAffiliation': 'University of Pittsburgh'}}}}