Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-02 @ 6:02 PM
Study NCT ID:
NCT00990912
Status:
COMPLETED
Last Update Posted:
2010-02-05
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'dispFirstSubmitDate': '2010-02-03', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-03', 'studyFirstSubmitDate': '2009-10-05', 'dispFirstSubmitQcDate': '2010-02-03', 'studyFirstSubmitQcDate': '2009-10-06', 'dispFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of safety and tolerability', 'timeFrame': '22 months'}], 'secondaryOutcomes': [{'measure': 'Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment', 'timeFrame': 'Every other cycle for 22 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pediatric Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of at least 6 cycles of therapy on BMS clinical protocol CA124-001 or CA124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy\n* Karnofsky score of at least 50 for subjects \\> 10 years of age; Lansky play scale of at least 50 for children 10 years of age and younger\n* Recovery to baseline or Grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies\n* Males and females, ages 1 - 21 years of age at the time of consent into CA124-001 or CA124-002\n\nExclusion Criteria:\n\n* A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy\n* Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study\n* Inadequate bone marrow and renal function\n* Concurrent receipt of Dilantin®(phenytoin), phenobarbital, primidone, Tegretol®(carbamazepine), Depacon®, Depakene®, Depakote®, and Deproic®(valproic acid)'}, 'identificationModule': {'nctId': 'NCT00990912', 'briefTitle': 'A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Study to Document Long-term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects 1 - 21 Years of Age With Refractory Solid Tumors Who Have Experienced Clinical Benefit Following a Minimum of 6 Cycles of Therapy on BMS Protocol CA124-001 or BMS Protocol CA124-002', 'orgStudyIdInfo': {'id': 'CA124-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carboplatin', 'interventionNames': ['Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Irinotecan (12 (9) mg/m²/day)', 'interventionNames': ['Drug: Irinotecan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Irinotecan (10 (10) mg/m²/day', 'interventionNames': ['Drug: Irinotecan']}], 'interventions': [{'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin', 'BMY-26575'], 'description': 'IV, Infusion, AUC2 mg/ml.min, Once every 21 days, until progression or unacceptable toxicity', 'armGroupLabels': ['Carboplatin']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['Camptosar', 'Campto'], 'description': 'IV, Infusion, 12 (9) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity', 'armGroupLabels': ['Irinotecan (12 (9) mg/m²/day)']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['Camptosar', 'Campto'], 'description': 'IV, Infusion, 10 (18) mg/m²/day, Once daily x 10 days, every 21 days, until progression or unacceptable toxicity', 'armGroupLabels': ['Irinotecan (10 (10) mg/m²/day']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}