Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 12:31 PM
Study NCT ID:
NCT04863950
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2021-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent 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': 'D008130', 'term': 'Lomustine'}, {'id': 'D007099', 'term': 'Imipramine'}], 'ancestors': [{'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2021-04-23', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject is at least 18 years of age\n* The subject has the ability to understand the purposes and risks of the study and to have signed a written informed consent form approved by the investigator's IRB/Ethics Committee\n* The subject has histologically confirmed glioblastoma\n* The subject has progression following standard combined modality treatment with radiation and temozolomide chemotherapy\n* The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2\n* The subject has a life expectancy of at least 3 months\n* The subject has acceptable liver function:\n* Bilirubin ≤ 1.5 times upper limit of normal\n* AST (aspartate aminotransferase) (SGOT) and ALT (alanine transaminase 0 (SGPT) ≤ 3.0 times upper limit of normal (ULN)\n* The subject has acceptable renal function:\n* Serum creatinine ≤ULN\n* The subject has acceptable hematologic status (without hematologic support):\n* ANC (absolute neutrophil count) ≥1500 cells/uL\n* Platelet count ≥100,000/uL\n* Hemoglobin ≥9.0 g/dL\n* All women of childbearing potential (not surgically sterilized or at least 1 year post-menopausal) must have a negative serum pregnancy test. Additionally, male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.\n\nExclusion Criteria:\n\n* The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.\n* The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.\n* The subject is unable to undergo MRI scan (eg, has pacemaker).\n* The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).\n* The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug.\n* The subject has evidence of wound dehiscence.\n* The subject is pregnant or breast-feeding.\n* The subject has a history of cardiac disease, including arrhythmia, conduction abnormality, congenital prolonged QT syndrome, myocardial infarction, unstable angina pectoris or congestive heart failure.\n* A prolonged QTc rhythm noted during initial ECG \\>480 ms.\n* The subject has serious intercurrent illness, such as:\n* Hypertension (two or more blood pressure \\[BP\\] readings performed at screening of \\> 150 mmHg systolic or \\> 100 mmHg diastolic) despite optimal treatment\n\n * Non-healing wound, ulcer, or bone fracture\n * Untreated hypothyroidism\n * Unhealed rectal or peri-rectal abscess\n * Uncontrolled active infection\n * Stroke, or transient ischemic attack within 6 months\n* The subject has received any of the following prior anticancer therapy:\n\n * Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed\n * Non-bevacizumab systemic therapy (including investigational agents and small- molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug\n * Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug\n * Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\n * Prior treatment with carmustine wafers\n* Any current psychosis, uncontrolled mood disorder (as assessed by investigator) or suicidal ideation. Additionally, current or history of bipolar disorder is excluded.\n* Patients currently using SSRI, SNRI, MAO inhibitors, tramadol or trazodone who are unwilling to undergo taper."}, 'identificationModule': {'nctId': 'NCT04863950', 'briefTitle': 'Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'A Phase II, Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma', 'orgStudyIdInfo': {'id': 'CTMS# 20-0148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imipramine Hydrochloride/Lomustine', 'interventionNames': ['Drug: Lomustine', 'Drug: Imipramine Hydrochloride']}], 'interventions': [{'name': 'Lomustine', 'type': 'DRUG', 'otherNames': ['Gleostine'], 'description': 'For surgical cohort patients, lomustine will be initiated (C1D1) within 6 weeks of surgery as soon as patient is deemed by the investigator (or designee) to be recovered enough for chemotherapy. Initiation of lomustine must be initiated within 6 weeks. If patient cannot be safely initiated on lomustine within this timeframe then they will be replaced.\n\nFor non-surgical cohort patients (the decision for surgery is made independent of study participation), lomustine will be initiated on C1D1.\n\nFor both cohorts, lomustine will be administered as 110 mg/m2 PO once every 6 weeks.', 'armGroupLabels': ['Imipramine Hydrochloride/Lomustine']}, {'name': 'Imipramine Hydrochloride', 'type': 'DRUG', 'otherNames': ['Trofranil'], 'description': 'For the surgical cohort, imipramine hydrochloride will be initiated within a minimum of 16 days to a maximum of 3 weeks prior to surgery. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day to attain a maximum dose of 200mg/day in 16 days.\n\nFor non-surgical cohort patients (the decision for surgery is made independent of study participation), imipramine hydrochloride will be initiated on Cycle 1 Day 1. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day, if tolerated, to attain a maximum dose of 200mg/day in 16 days.', 'armGroupLabels': ['Imipramine Hydrochloride/Lomustine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Epp Goodwin', 'role': 'CONTACT', 'phone': '210-450-1000'}, {'name': 'William Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mays Cancer Center, UT Health San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Epp Goodwin', 'role': 'CONTACT', 'email': 'goodwine@uthscsa.edu', 'phone': '210 450 5798'}, {'name': 'Maggie Tomasini', 'role': 'CONTACT', 'email': 'tomasinim@uthscsa.edu', 'phone': '210 450 5962'}], 'overallOfficials': [{'name': 'William Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center - Mays Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Investigator', 'investigatorFullName': 'William Kelly', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}