Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-04 @ 4:03 PM
Study NCT ID:
NCT00442533
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2007-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D002276', 'term': 'Carcinoid Tumor'}, {'id': 'D013005', 'term': 'Somatostatinoma'}, {'id': 'D010235', 'term': 'Paraganglioma'}, {'id': 'D010673', 'term': 'Pheochromocytoma'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018273', 'term': 'Carcinoma, Islet Cell'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'dispFirstSubmitDate': '2023-03-23', 'completionDateStruct': {'date': '2015-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2007-03-01', 'studyFirstSubmitQcDate': '2007-03-01', 'dispFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in solid tumor dimensions by CT scan.', 'timeFrame': 'Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments', 'description': 'Change in diameters of measurable lesions on CT using RECIST. and will be classified into 4 groups.\n\n1. Complete response\n2. Partial response\n3. No change or stable disease\n4. Progression'}], 'secondaryOutcomes': [{'measure': 'Frequency and severity of adverse events', 'timeFrame': 'up to 6 months following the last cycle of therap', 'description': 'Frequency and severity of adverse events. All adverse events will be graded using NCI common toxicities criteria'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Carcinoid', 'Islet Cell Cancer', 'Paraganglioma', 'Pheochromocytoma'], 'conditions': ['Neuroendocrine Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy.\n* Patients must have evidence of residual multifocal active tumor.\n* All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved.\n* All patients must have a Karnofsky performance status of at least 60.\n* Patients must be greater than 18 years of age.\n* Patients must have measurable and/or followable disease based on either clinical or radiologic exam.\n* Sensitivity to Indium-111 pentetreotide or any of its components is an absolute contraindication to participation in this trial.\n* An absolute contraindication is pregnancy as evidenced by the clinical condition, a positive pregnancy test (Beta type Human chorionic gonadotropin (β-HCG) or pelvic ultrasound).\n* If patients have received prior radionuclide therapy of the same product, there must be documented response to that therapy and/or residual active stable disease.\n\nExclusion Criteria:\n\n* Karnofsky performance status of 50 or less.\n* Patients who are unable to give informed consent.\n* Patients under 18 years of age. There will be no upper age discrimination.\n* Patients who are pregnant or those potentially pregnant subjects not willing to practice effective contraceptive techniques during the study period.\n* Patients with renal insufficiency as defined by a calculated creatinine clearance (based on age, weight and serum creatinine) of 39.9 ml/min or less.'}, 'identificationModule': {'nctId': 'NCT00442533', 'briefTitle': 'Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Radio Isotope Therapy of America'}, 'officialTitle': 'High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.', 'orgStudyIdInfo': {'id': '06-2247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indium-111 pentetreotide', 'description': '4 cycles of 500 mCi treatments every 10-12 weeks', 'interventionNames': ['Drug: Indium-111 pentetreotide']}], 'interventions': [{'name': 'Indium-111 pentetreotide', 'type': 'DRUG', 'otherNames': ['NeuroendoMedix'], 'description': '4 cycles of 500 mCi treatments every 10-12 weeks', 'armGroupLabels': ['Indium-111 pentetreotide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77042', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Excel Diagnostic Imaging Clinics', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77225-0269', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'St. Lukes Episcopal Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ebrahim Delpassand, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RITA Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radio Isotope Therapy of America', 'class': 'OTHER'}, 'collaborators': [{'name': 'Excel Diagnostic Imaging Clinics', 'class': 'UNKNOWN'}, {'name': 'Radiomedix, Inc.', 'class': 'INDUSTRY'}, {'name': "CHI St. Luke's Health, Texas", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President and CEO', 'investigatorFullName': 'Ebrahim Delpassand', 'investigatorAffiliation': 'Radio Isotope Therapy of America'}}}}