Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:55 PM
Study NCT ID:
NCT00915694
Status:
TERMINATED
Last Update Posted:
2019-04-23
First Post:
2009-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With 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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019888', 'term': 'Nelfinavir'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Insufficient accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-22', 'studyFirstSubmitDate': '2009-06-05', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose of nelfinavir mesylate', 'timeFrame': '90 days'}, {'measure': 'Dose-limiting toxicities as assessed by NCI CTC v3.0', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'One year'}, {'measure': 'Overall survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adult giant cell glioblastoma', 'adult gliosarcoma', 'adult glioblastoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.gov/clinicaltrials', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir mesylate together with radiation therapy and temozolomide may kill more tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate when given together with radiation therapy and temozolomide in treating patients with glioblastoma multiforme.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of nelfinavir mesylate when given concurrently with radiotherapy and temozolomide followed by temozolomide alone in patients with glioblastoma multiforme.\n* Determine the safety and dose-limiting toxicities of this regimen in these patients.\n\nSecondary\n\n* Determine the progression-free survival (PFS) and overall survival (OS) of patients treated with this regimen.\n* Compare the observed median values of PFS and OS obtained in this study to the historical median values of 6.9 months and 14.6 months, respectively.\n\nOUTLINE: This is a dose-escalation study of nelfinavir mesylate.\n\nPatients receive oral nelfinavir mesylate twice daily beginning 7-10 days before the initiation of chemoradiotherapy and continuing until the completion of chemoradiotherapy. Patients undergo radiotherapy once daily 5 days a week and receive concurrent oral temozolomide once daily for 6 weeks. Beginning 4 weeks after completion of nelfinavir mesylate and chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study therapy, patients are followed periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed WHO grade IV supratentorial astrocytoma (glioblastoma multiforme)\n\n * Newly diagnosed disease\n* Has undergone maximal surgical resection\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* ANC ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Serum creatinine \\< 1.5 times upper limit of normal (ULN)\n* AST or ALT \\< 2 times ULN\n* Serum bilirubin \\< 1.5 mg/dL\n* No known HIV infection\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior cranial radiotherapy\n* More than 30 days since prior investigational agents\n* No other concurrent investigational agents\n* No concurrent use of any of the following drugs:\n\n * Antiarrhythmics (i.e., amiodarone or quinidine)\n * Antimycobacterials (i.e., rifampin)\n * Ergot derivatives (i.e., dihydroergotamine, ergonovine, ergotamine, or methylergonovine)\n * Herbal products (i.e., St. John's wort)\n * HMG-CoA reductase inhibitors (i.e., lovastatin or simvastatin)\n * Neuroleptics (i.e., pimozide)\n * Sedatives and/or hypnotics (i.e., midazolam or triazolam)\n* Concurrent corticosteroids allowed provided dose has been stable or decreasing for ≥ 14 days prior to study entry"}, 'identificationModule': {'nctId': 'NCT00915694', 'briefTitle': 'Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma', 'orgStudyIdInfo': {'id': 'CDR0000644278'}, 'secondaryIdInfos': [{'id': 'UPCC-01309'}, {'id': 'IRB#809463'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'NFV-RT-Tem', 'interventionNames': ['Drug: nelfinavir mesylate', 'Drug: temozolomide', 'Procedure: adjuvant therapy', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'nelfinavir mesylate', 'type': 'DRUG', 'armGroupLabels': ['Single arm']}, {'name': 'temozolomide', 'type': 'DRUG', 'armGroupLabels': ['Single arm']}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['Single arm']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jay F. Dorsey, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}