Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-03-12 @ 6:15 AM
Study NCT ID:
NCT00016861
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-11', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2001-06-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, '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.\n\nPURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children who have refractory or progressive solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan in children with refractory or progressive solid tumors.\n* Determine the pharmacokinetics of this drug and its metabolites (SN-38, SN-38G, and APC) administered with and without concurrent anticonvulsants in this patient population.\n* Determine the benefit this drug offers this patient population.\n\nOUTLINE: This is a dose-escalation, multicenter study. Patients are accrued into stratum 1 initially and into stratum 2 if stratum 1 closes due to dose-limiting toxicity of myelosuppression or diarrhea. Patients on anticonvulsants will be accrued into stratum 3 and must meet the eligibility criteria for the stratum that is open (stratum 1 or stratum 2). (Stratum 1 closed as of 2002-09-15).\n\nPatients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) with and without anticonvulsants is determined. The MTD is defined as the dose preceding that at which 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: Approximately 20-25 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed solid tumor refractory to standard therapy or for which no known effective therapy exists\n\n * Brain tumors eligible\n\n * Histologic verification waived for brain stem gliomas\n* Evaluable disease\n* No bone marrow involvement\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 1 to 21\n\nPerformance status:\n\n* Karnofsky 50-100% (over age 10)\n* Lansky 50-100% (age 10 and under)\n\nLife expectancy:\n\n* At least 8 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 8 g/dL\n\nHepatic:\n\n* Bilirubin less than 1.5 mg/dL\n* SGPT less than 5 times normal\n\nRenal:\n\n* Creatinine normal OR\n* Glomerular filtration rate at least 70 mL/min\n\nOther:\n\n* No uncontrolled infection\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 6 months since prior autologous bone marrow transplantation (BMT) (not including stem cell rescue after high-dose chemotherapy)\n* At least 1 week since prior growth factors\n* No prior BMT with total body irradiation (stratum I)\n* No prior BMT with or without total body irradiation (stratum 2)\n* No prior allogeneic BMT (all strata)\n* No concurrent sargramostim (GM-CSF)\n* No other concurrent prophylactic growth factor support during the first course of therapy\n\nChemotherapy:\n\n* At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)\n* No prior irinotecan\n* No more than 2 prior multi-agent chemotherapy regimens (stratum 2)\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Concurrent dexamethasone allowed if on stable or decreasing dose for at least 2 weeks prior to study\n\nRadiotherapy:\n\n* At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis\n* At least 6 weeks since other prior substantial bone marrow radiotherapy\n* No prior central axis radiotherapy, pelvic radiotherapy, and/or total abdominal radiotherapy (stratum 2)\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* Recovered from all prior therapy\n* No other concurrent investigational agents\n* Concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine) allowed if on stable dose for at least 2 weeks prior to study (stratum 3)\n* Concurrent valproic acid allowed if combined with another enzyme inducing anticonvulsant drug (stratum 3)'}, 'identificationModule': {'nctId': 'NCT00016861', 'briefTitle': 'Irinotecan in Treating Children With Refractory or Progressive Solid Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Pediatric Phase I and Pharmacokinetic Study of Irinotecan', 'orgStudyIdInfo': {'id': 'TCCC-H-6957'}, 'secondaryIdInfos': [{'id': 'CDR0000068568', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'TCCC-GCRC-0654'}, {'id': 'NCI-V01-1654'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'irinotecan hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030-2399', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Cancer Center", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Susan M. Blaney, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Texas Children's Cancer Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Texas Children's Cancer Center", 'class': 'OTHER'}}}}