Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT00006095
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2000-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-20', 'studyFirstSubmitDate': '2000-08-03', 'studyFirstSubmitQcDate': '2003-05-21', 'lastUpdatePostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Length of study'}], 'secondaryOutcomes': [{'measure': 'Toxicity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified childhood solid tumor, protocol specific'], 'conditions': ['Unspecified Childhood Solid Tumor, Protocol Specific']}, '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 I trial to study the effectiveness of vincristine plus irinotecan in treating children who have solid tumors that have not responded to previous therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose and dose limiting toxicity of vincristine when administered in combination with irinotecan in children with refractory solid tumors.\n* Determine the safe and tolerable phase II dose of this combination regimen in this patient population.\n* Determine the pharmacokinetics of this combination regimen in these patients.\n* Determine the incidence and severity of other toxicities of this combination regimen in these patients.\n* Determine preliminary evidence of antitumor activity of this combination regimen in this patient population.\n\nOUTLINE: This is a dose-escalation study of vincristine.\n\nPatients receive vincristine IV on day 2 of the first course (day 1 of subsequent courses) and days 8, 15, 22, and 29, and irinotecan IV over 1 hour on days 1-5 and 22-26. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease receive additional courses of therapy for a maximum of 1 year.\n\nCohorts of 3-6 patients receive escalating doses of vincristine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity.\n\nPatients are followed every 6 months for 4 years and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 3-12 patients will be accrued for this study within 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed initial diagnosis of malignant solid tumor refractory to conventional therapy or for which no effective therapy exists\n\n * Brain tumors allowed if not on anticonvulsants\n * Brainstem gliomas allowed without histologic diagnosis\n * Solid lymphomas allowed\n* No bone marrow involvement\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 1 to 21\n\nPerformance status:\n\n* Karnofsky 50-100% if over 10 years of age\n* Lansky 50-100% if 10 years of age and under\n\nLife expectancy:\n\n* At least 8 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 8 g/dL (transfusion allowed)\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* ALT less than 5 times normal\n* Albumin at least 2 g/dL\n\nRenal:\n\n* Creatinine normal for age OR\n* Glomerular filtration rate normal for age\n\nOther:\n\n* No uncontrolled infection\n* No other significant systemic illness\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 1 week since prior biologic therapy and recovered\n* At least 1 week since prior growth factors\n* No prior stem cell transplantation\n\nChemotherapy:\n\n* At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered\n* No more than 2 prior chemotherapy regimens\n* No other concurrent cancer chemotherapy\n\nEndocrine therapy:\n\n* Concurrent dexamethasone allowed in patients with CNS tumors provided dose is stable or decreasing for at least 2 weeks prior to study\n\nRadiotherapy:\n\n* Recovered from prior radiotherapy\n* At least 2 weeks since prior local palliative radiotherapy (small port)\n* No prior substantial bone marrow radiotherapy\n* No prior central axis radiotherapy\n* No concurrent radiotherapy\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent anticonvulsants\n* No other concurrent anticancer therapy or investigational agents'}, 'identificationModule': {'nctId': 'NCT00006095', 'briefTitle': 'Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors', 'orgStudyIdInfo': {'id': 'P9971'}, 'secondaryIdInfos': [{'id': 'COG-P9971', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CCG-P9971', 'type': 'OTHER', 'domain': "Children's Cancer Group"}, {'id': 'POG-9971', 'type': 'OTHER', 'domain': 'Pediatric Oncology Group'}, {'id': 'CDR0000068102', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan', 'interventionNames': ['Drug: irinotecan hydrochloride', 'Drug: vincristine sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Vincristine sulfate 2.0 mg/m2/wk and Irinotecan', 'interventionNames': ['Drug: irinotecan hydrochloride', 'Drug: vincristine sulfate']}], 'interventions': [{'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'otherNames': ['CPT-11', 'NSC #616348'], 'armGroupLabels': ['Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan', 'Vincristine sulfate 2.0 mg/m2/wk and Irinotecan']}, {'name': 'vincristine sulfate', 'type': 'DRUG', 'otherNames': ['VCR', 'Oncovin', 'NSC #067574'], 'armGroupLabels': ['Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan', 'Vincristine sulfate 2.0 mg/m2/wk and Irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Center and Beckman Research Institute, City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90027-0700', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94143-0128', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Cancer Center and Cancer Research Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20010-2970', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '46202-5289', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48109-0752', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "NYU School of Medicine's Kaplan Comprehensive Cancer Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital Medical Center - Cincinnati", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Children's Hospital and Regional Medical Center - Seattle", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792-6164', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '6001', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Princess Margaret Hospital for Children', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Cynthia S. Kretschmar, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Floating Hospital for Children at Tufts - New England Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}