Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT00306618
Status:
COMPLETED
Last Update Posted:
2008-12-10
First Post:
2006-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077584', 'term': '2-Methoxyestradiol'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-09', 'studyFirstSubmitDate': '2006-03-22', 'studyFirstSubmitQcDate': '2006-03-22', 'lastUpdatePostDateStruct': {'date': '2008-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 month progression free survival and median overall survival', 'timeFrame': 'time of progression; survival'}]}, 'conditionsModule': {'conditions': ['Recurrent Glioblastoma Multiforme']}, 'descriptionModule': {'briefSummary': 'This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma).\n* 18 years or older\n* An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks)\n* Karnofsky performance score equal to or greater than 70%\n* Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters\n* Serum creatinine less than 1.5 X upper limit of normal (ULN), serum SGOT less than 2.5 X ULN; and bilirubin less than 1.5 times ULN\n* Signed informed consent form and authorization for use and disclosure of protected health information approved by the IRB prior to patient entry\n* Agree to use effective contraceptive methods\n\nExclusion Criteria:\n\n* Current, active systemic bleeding or excessive risk of bleeding\n* Be pregnant or lactating; not employing effective birth control\n* Concurrent severe and/or uncontrolled medical disease\n* Impairment of gastrointestinal (GI) function/disease\n* Requirement for therapy with coumadin (warfarin sodium)\n* Patient is less than 5 years free of another primary malignancy\n* Patients unwilling to or unable to comply with the protocol\n* Grade 2 or greater peripheral sensory neuropathy'}, 'identificationModule': {'nctId': 'NCT00306618', 'briefTitle': 'Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'CASI Pharmaceuticals, Inc.'}, 'officialTitle': 'A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme', 'orgStudyIdInfo': {'id': 'ME-CLN-005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Panzem Nanocrystal Colloidal Dispersion', 'type': 'DRUG', 'otherNames': ['2-methoxyestradiol', '2ME2'], 'description': 'Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Brain Tumor Center, Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'David A. Reardon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Brain Center at Duke, Duke University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CASI Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'EntreMed, Inc.'}}}}