Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-06-16 @ 8:01 PM
Study NCT ID:
NCT00860860
Status:
COMPLETED
Last Update Posted:
2012-03-19
First Post:
2009-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000615551', 'term': 'Indium-111'}, {'id': 'C000615061', 'term': 'Lutetium-177'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-16', 'studyFirstSubmitDate': '2009-03-11', 'studyFirstSubmitQcDate': '2009-03-11', 'lastUpdatePostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0', 'timeFrame': 'first three weeks: daily, thereafter: weekly'}], 'secondaryOutcomes': [{'measure': 'pharmacokinetics and biodistribution of TF2 and Lu-177-labeled IMP-288, sensitivity of pretargeted imaging with In-111-labeled IMP-288, and tumor response using RECIST criteria', 'timeFrame': 'Pk/biodistr: first week after administration; imaging: first 5 days after administration of IMP-288-In111; tumor respone: every 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['radioimmunotherapy', 'pretargeting', 'bispecific antibody', 'lutetium 177', 'phase I clinical trial'], 'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study will investigate the toxicity, safety and pharmacokinetics of pretargeted radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the preliminary efficacy of the therapy.', 'detailedDescription': 'Pretherapy cycle with IMP-288 labeled In111.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available\n* WHO performance status: 0 or 1\n* Having normal hematological function: Neutrophils \\> 1.5 x 109/l; Platelet count \\> 150 x 109/l, without transfusion during the previous month; Hemoglobin \\> 5.6 mmol/l\n* Total bilirubin \\< 2 x upper limit of normal (ULN)\n* ASAT, ALAT \\< 3 x ULN\n* Serum creatinine \\< 2 x ULN\n* Cockcroft clearance \\> 50 ml/min\n* Negative pregnancy test for women of child¬bearing potential (urine or serum)\n* Age over 18 years\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Known metastases to the brain\n* Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.\n* Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks\n* Cardiac disease with New York Heart Association classification of III or IV\n* Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception\n* Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status\n* Life expectancy shorter than 6 months."}, 'identificationModule': {'nctId': 'NCT00860860', 'acronym': 'PRIT2008', 'briefTitle': 'Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Phase I Clinical Study of the Feasibility of Pretargeted Radioimmunotherapy of an Anti-CEA Bispecific Antibody and Lu-177-labeled Peptide in Patients With Advanced Colorectal Cancer', 'orgStudyIdInfo': {'id': 'RUNMC-PRIT2008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TF2', 'type': 'DRUG', 'description': 'TF2: 75-300 mg'}, {'name': 'IMP-288 labeled with In111 and Lu177', 'type': 'DRUG', 'description': 'IMP-288: 100 microgram'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'O C Boerman, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'RUNMC Department of Nuclear Medicine'}, {'name': 'R Schoffelen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'RUNMC Department of Nuclear Medicine'}, {'name': 'W JG Oyen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RUNMC Department of Nuclear Medicine'}, {'name': 'W TA van der Graaf, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RUNMC Department of Medical Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}