Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-10 @ 1:10 AM
Study NCT ID:
NCT00099060
Status:
COMPLETED
Last Update Posted:
2014-01-27
First Post:
2004-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme
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': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], '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': 'D000077341', 'term': 'Lapatinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-24', 'studyFirstSubmitDate': '2004-12-08', 'studyFirstSubmitQcDate': '2004-12-08', 'lastUpdatePostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity for phase I assessed by CTCAE v.3.0 MacDonald criteria', 'timeFrame': '7 years'}, {'measure': 'Response for phase II', 'timeFrame': '7 years'}], 'secondaryOutcomes': [{'measure': 'Correlative studies on archival tissue', 'timeFrame': '7 years'}, {'measure': 'Pharmacokinetics', 'timeFrame': '7 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adult giant cell glioblastoma', 'adult gliosarcoma', 'recurrent adult brain tumor'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.\n\nPURPOSE: This phase I/II trial is studying the side effects and best dose of lapatinib and to see how well it works in treating patients with recurrent glioblastoma multiforme.', 'detailedDescription': 'OBJECTIVES:\n\nPhase I\n\n* Determine the maximum tolerated dose and recommended phase II dose of lapatinib in patients with recurrent malignant glioblastoma multiforme who are taking CYP3A4 enzyme-inducing anti-epileptic drugs (EIAEDs).\n* Determine the toxic effects of this drug in these patients.\n* Determine the pharmacokinetics of this drug in these patients.\n\nPhase II\n\n* Determine the efficacy of this drug, in terms of objective tumor response rate, in patients who are taking EIAEDs and in those who are not taking EIAEDs.\n* Correlate immunohistochemical measures of cellular proteins and receptors from tumor samples with anti-tumor activity of this drug in these patients.\n* Determine the pharmacokinetics of this drug in these patients.\n\nOUTLINE: This is a multicenter, open-label, phase I, dose-escalation study followed by a phase II study.\n\n* Phase I: Patients receive oral lapatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.\n\nCohorts of 3-6 patients receive escalating doses of lapatinib until the maximum tolerated dose (MTD) 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\n* Phase II: Patients receive lapatinib as in phase I at the MTD. Patients are followed at 1 month and then periodically for survival. Patients with stable or responding disease who go off therapy are followed every 3 months for up to one year and then periodically thereafter for survival.\n\nPROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 18 months. A total of 15-30 patients will be accrued for the phase II portion of this study within 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed malignant glioblastoma multiforme\n* Recurrent or progressive disease after prior primary treatment with radiotherapy with or without adjuvant chemotherapy\n* Bidimensionally measurable disease on CT scan or MRI with at least one lesion ≥ 1 cm x 1 cm\n* Paraffin embedded tumor sample available\n* Concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) required for phase I of the study\n\n * Patients in phase II of the study may or may not be receiving EIAEDs\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute granulocyte count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ upper limit of normal (ULN)\n* AST and ALT ≤ 2.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nCardiovascular\n\n* LVEF ≥ 50% by echocardiogram or MUGA\n* No myocardial infarction within the past 6 months\n* No congestive heart failure\n* No unstable angina\n* No active cardiomyopathy\n* No cardiac arrhythmia\n* No uncontrolled hypertension\n\nPulmonary\n\n* No pulmonary disease requiring oxygen\n\nNeurologic\n\n* No preexisting peripheral neuropathy ≥ grade 3\n* No history of significant neurologic disorder that would preclude study compliance or ability to give informed consent\n\nGastrointestinal\n\n* No upper gastrointestinal or other conditions that would preclude compliance with oral medication\n* No active peptic ulcer disease\n\nOther\n\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor\n* No immune deficiency\n* No history of significant psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude study compliance or ability to give informed consent\n* No other serious illness or medical condition that would preclude study participation\n* No known hypersensitivity to compounds of similar chemical or biological composition to lapatinib\n* No active uncontrolled or serious infection\n* HIV negative\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* No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other hematopoietic growth factors\n\n * Concurrent hematopoietic growth factors allowed for treatment of acute toxicity (e.g., febrile neutropenia)\n\nChemotherapy\n\n* See Disease Characteristics\n* No prior chemotherapy for recurrent disease\n* No more than one prior chemotherapy regimen in the adjuvant setting\n\n * At least 6 months since prior adjuvant chemotherapy\n\nEndocrine therapy\n\n* Concurrent steroids allowed provided the dose is stable for at least 14 days before study entry\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 6 weeks since prior radiotherapy\n\nSurgery\n\n* At least 2 weeks since prior major surgery\n\nOther\n\n* H2 blockers and proton pump inhibitors allowed, unless they are CYP3A4 inducers or inhibitors\n* At least 7 days since prior and no concurrent administration of any of the following CYP3A4 inhibitors:\n\n * Clarithromycin\n * Erythromycin\n * Troleandomycin\n * Telithromycin\n * Ciprofloxacin\n * Norfloxacin\n * Itraconazole\n * Ketoconazole\n * Voriconazole\n * Fluconazole (≤150 mg/day allowed)\n * Nefazodone\n * Fluovoxamine\n * Delavirdine\n * Nelfinavir\n * Amprenavir\n * Ritonavir\n * Indinavir\n * Saquinavir\n * Lopinavir\n * Verapamil\n * Diltiazem\n * Aprepitant\n * Grapefruit or grapefruit juice\n * Bitter orange\n* At least 14 days since prior and no concurrent administration of any of the following CYP3A4 inducers:\n\n * Rifampin\n * Rifabutin\n * Rifapentine\n * Efavirenz\n * Nevirapine\n * Hypericum perforatum (St. John's wort)\n * Modafinil\n* At least 6 months since prior and no concurrent administration of amiodarone\n* Antacids (e.g., mylanta, maalox, tums, rennies) must be administered ≥ 1 hour before and ≥ 1 hour after study drug\n* At least 2 days since prior and no concurrent cimetidine\n* No other concurrent anti-cancer agents\n* No other concurrent investigational therapy"}, 'identificationModule': {'nctId': 'NCT00099060', 'briefTitle': 'Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma', 'orgStudyIdInfo': {'id': 'I170'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-IND170'}, {'id': 'CDR0000389155', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'lapatinib ditosylate', 'type': 'DRUG', 'description': 'For patients receiving enzyme inducing anti-epileptic drugs (EIAEDs):\n\n* Phase I: starting dose for first cohort: 1000 mg GW572016 po b.i.d.; actual dose assigned at registration; intra patient dose escalation permitted ONCE in phase I patients ONLY if specified criteria met (see section 8.6).\n* Phase II: Recommended phase II dose from phase I portion of the study, given po b.i.d.\n\nFor patients NOT receiving enzyme inducing anti-epileptic drugs (NON-EIAEDs):\n\n• Phase II: 750 mg GW572016 po b.i.d.\n\nFor all patients:\n\n• Dose reductions as required based on adverse events.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre - Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V1Y 5L3', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Centre for the Southern Interior', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Vancouver Cancer Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Margaret and Charles Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2L-4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Brian A. Thiessen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'British Columbia Cancer Agency'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'collaborators': [{'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}