Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 6:08 AM
Study NCT ID:
NCT00002794
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carboplatin Plus Vincristine in Treating Children With Retinoblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012175', 'term': 'Retinoblastoma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D019572', 'term': 'Retinal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-03', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-04-23', 'lastUpdatePostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['intraocular retinoblastoma'], 'conditions': ['Retinoblastoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma.', 'detailedDescription': 'OBJECTIVES: I. Estimate the objective response rate in infants and children with retinoblastoma when treated with carboplatin (CBDCA) and vincristine (VCR) every 3 weeks for 24 weeks. II. Assess the success of this regimen in delaying radiotherapy and eliminating the need for surgery by estimating the cumulative incidence function of treatment failure. III. Estimate the cumulative incidence of failure of this regimen as measured by subsequent treatment with radiotherapy or surgery.\n\nOUTLINE: All patients receive carboplatin and vincristine every 3 weeks for a maximum of 8 courses. Patients with disease progression after at least 2 courses are removed from study and considered for alternative therapy. Patients are followed every 6 weeks for 1 year, every 2 months for 1 year, every 3-4 months for 3 years, and yearly for 12 years.\n\nPROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 4.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Newly diagnosed retinoblastoma Bilateral or multifocal unilateral disease in children under age 10 Unilateral, multifocal tumors less than 5 dd in children under age 2 No metastatic disease Disease evidenced by ophthalmoscopic/imaging exam, ultrasound, CT, or MRI Fundus drawings and photographs required\n\nPATIENT CHARACTERISTICS: Age: 10 and under Performance status: Not specified Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified'}, 'identificationModule': {'nctId': 'NCT00002794', 'briefTitle': 'Carboplatin Plus Vincristine in Treating Children With Retinoblastoma', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma', 'orgStudyIdInfo': {'id': 'CDR0000064874'}, 'secondaryIdInfos': [{'id': 'P30CA021765', 'link': 'https://reporter.nih.gov/quickSearch/P30CA021765', 'type': 'NIH'}, {'id': 'P01CA023099', 'link': 'https://reporter.nih.gov/quickSearch/P01CA023099', 'type': 'NIH'}, {'id': 'SJCRH: RET3'}, {'id': 'NCI-H96-0935'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'vincristine sulfate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee, Memphis Cancer Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38105-2794', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Saint Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Carlos Rodriguez-Galindo, MD', 'role': 'STUDY_CHAIR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}