Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT00039468
Status:
COMPLETED
Last Update Posted:
2011-10-27
First Post:
2002-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D018316', 'term': 'Gliosarcoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-26', 'studyFirstSubmitDate': '2002-06-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response', 'timeFrame': '2 years', 'description': 'To evaluate the response rate and hence preliminary efficacy of Irinotecan and Thalidomide following radiotherapy in the treatment of newly diagnosed or relapsed glioblastoma multiforme.'}], 'secondaryOutcomes': [{'measure': 'Toxicity / QOL / Survival', 'timeFrame': '2 years', 'description': 'To evaluate 1) toxicity 2) quality of life 3) disease free survival and 4) overall survival of patients treated with this combination.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adult glioblastoma', 'recurrent adult brain tumor', 'adult giant cell glioblastoma', 'adult gliosarcoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'references': [{'pmid': '18661102', 'type': 'RESULT', 'citation': 'Fadul CE, Kingman LS, Meyer LP, Cole BF, Eskey CJ, Rhodes CH, Roberts DW, Newton HB, Pipas JM. A phase II study of thalidomide and irinotecan for treatment of glioblastoma multiforme. J Neurooncol. 2008 Nov;90(2):229-35. doi: 10.1007/s11060-008-9655-9. Epub 2008 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells remaining after radiation therapy.\n\nPURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the response rate of patients with glioblastoma multiforme treated with thalidomide and irinotecan after radiotherapy.\n* Determine the preliminary efficacy of this regimen in these patients.\n* Determine the disease-free survival and overall survival of patients treated with this regimen.\n* Determine the toxicity of this regimen in these patients.\n* Assess the quality of life of patients treated with this regimen.\n\nOUTLINE: Beginning 2-4 weeks after completion of radiotherapy, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive oral thalidomide daily. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, 1 week after the first course, prior to all subsequent courses, and then after course 6.\n\nPatients are followed for 5 years.\n\nPROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed glioblastoma multiforme (GBM)\n\n * Recurrent disease allowed\n* Evaluable disease on contrast-enhanced MRI\n* Prior external beam radiotherapy required\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* AST or ALT no greater than 5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN OR\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular:\n\n* No significant cardiac disease\n* No uncontrolled high blood pressure\n* No unstable angina\n* No congestive heart failure\n* No myocardial infarction within the past 3 months\n* No serious cardiac arrhythmias\n\nGastrointestinal:\n\n* Able to take oral medication\n* No gastrointestinal abnormalities\n* No requirement for IV alimentation\n* No active peptic ulcer disease\n\nOther:\n\n* No active infection\n* No serious uncontrolled medical disorder\n* No dementia or significantly altered mental status that would preclude study\n* No known hypersensitivity to irinotecan or thalidomide\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use 2 forms of effective contraception, including 1 highly effective method, at least 1 month before, during, and for 1 month after study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior thalidomide\n\nChemotherapy:\n\n* No prior irinotecan\n* At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease progression or relapse)\n\nEndocrine therapy:\n\n* Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to study\n* No concurrent hormonal therapy for GBM\n\nRadiotherapy:\n\n* See Disease Characteristics\n* No concurrent radiotherapy for GBM\n\nSurgery:\n\n* No prior surgical procedures affecting absorption\n\nOther:\n\n* No other concurrent anticancer investigational agents for GBM\n* No concurrent cytochrome P450 inhibitors, including the following:\n\n * Nefazodone\n * Fluvoxamine\n * Fluoxetine\n * Sertraline\n * Paroxetine\n * Venlafaxine\n * Ketoconazole\n * Itraconazole\n * Fluconazole\n * Cimetadine\n * Clarithromycin\n * Diltiazem\n * Erythromycin\n * Protease inhibitors'}, 'identificationModule': {'nctId': 'NCT00039468', 'briefTitle': 'Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme', 'orgStudyIdInfo': {'id': 'D0134'}, 'secondaryIdInfos': [{'id': 'DMS-15615', 'type': 'OTHER', 'domain': 'Dartmouth-Hitchcock Medical Center'}, {'id': 'NCI-G02-2078', 'type': 'OTHER_GRANT', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'otherNames': ['CAMPTOSAR'], 'description': '350 or 700 mg/m2 IV every 3 weeks'}, {'name': 'thalidomide', 'type': 'DRUG', 'otherNames': ['THALOMID'], 'description': '400mg/day oral'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756-0002', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Camilo E. Fadul, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Norris Cotton Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}