RECRUITING

Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts.

Official Title

A Phase II, Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma

Quick Facts

Study Start:2022-05-25

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04863950

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* The subject is at least 18 years of age * 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 * The subject has histologically confirmed glioblastoma * The subject has progression following standard combined modality treatment with radiation and temozolomide chemotherapy * The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2 * The subject has a life expectancy of at least 3 months * The subject has acceptable liver function: * Bilirubin ≤ 1.5 times upper limit of normal * AST (aspartate aminotransferase) (SGOT) and ALT (alanine transaminase 0 (SGPT) ≤ 3.0 times upper limit of normal (ULN) * The subject has acceptable renal function: * Serum creatinine ≤ULN * The subject has acceptable hematologic status (without hematologic support): * ANC (absolute neutrophil count) ≥1500 cells/uL * Platelet count ≥100,000/uL * Hemoglobin ≥9.0 g/dL * 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.	* 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. * 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. * The subject is unable to undergo MRI scan (eg, has pacemaker). * The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone). * 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. * The subject has evidence of wound dehiscence. * The subject is pregnant or breast-feeding. * 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. * A prolonged QTc rhythm noted during initial ECG \>480 ms. * The subject has serious intercurrent illness, such as: * Hypertension (two or more blood pressure \[BP\] readings performed at screening of \> 150 mmHg systolic or \> 100 mmHg diastolic) despite optimal treatment * Non-healing wound, ulcer, or bone fracture * Untreated hypothyroidism * Unhealed rectal or peri-rectal abscess * Uncontrolled active infection * Stroke, or transient ischemic attack within 6 months * The subject has received any of the following prior anticancer therapy: * Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed * 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 * Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug * 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 * Prior treatment with carmustine wafers * Any current psychosis, uncontrolled mood disorder (as assessed by investigator) or suicidal ideation. Additionally, current or history of bipolar disorder is excluded. * Patients currently using SSRI, SNRI, MAO inhibitors, tramadol or trazodone who are unwilling to undergo taper.

Inclusion Criteria

Exclusion Criteria

* The subject is at least 18 years of age
* 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
* The subject has histologically confirmed glioblastoma
* The subject has progression following standard combined modality treatment with radiation and temozolomide chemotherapy
* The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
* The subject has a life expectancy of at least 3 months
* The subject has acceptable liver function:
* Bilirubin ≤ 1.5 times upper limit of normal
* AST (aspartate aminotransferase) (SGOT) and ALT (alanine transaminase 0 (SGPT) ≤ 3.0 times upper limit of normal (ULN)
* The subject has acceptable renal function:
* Serum creatinine ≤ULN
* The subject has acceptable hematologic status (without hematologic support):
* ANC (absolute neutrophil count) ≥1500 cells/uL
* Platelet count ≥100,000/uL
* Hemoglobin ≥9.0 g/dL
* 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.

* 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.
* 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.
* The subject is unable to undergo MRI scan (eg, has pacemaker).
* The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
* 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.
* The subject has evidence of wound dehiscence.
* The subject is pregnant or breast-feeding.
* 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.
* A prolonged QTc rhythm noted during initial ECG \>480 ms.
* The subject has serious intercurrent illness, such as:
* Hypertension (two or more blood pressure \[BP\] readings performed at screening of \> 150 mmHg systolic or \> 100 mmHg diastolic) despite optimal treatment
* Non-healing wound, ulcer, or bone fracture
* Untreated hypothyroidism
* Unhealed rectal or peri-rectal abscess
* Uncontrolled active infection
* Stroke, or transient ischemic attack within 6 months
* The subject has received any of the following prior anticancer therapy:
* Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
* 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
* Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
* 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
* Prior treatment with carmustine wafers
* Any current psychosis, uncontrolled mood disorder (as assessed by investigator) or suicidal ideation. Additionally, current or history of bipolar disorder is excluded.
* Patients currently using SSRI, SNRI, MAO inhibitors, tramadol or trazodone who are unwilling to undergo taper.

Contacts and Locations

Study Contact

Epp Goodwin

CONTACT

210 450 5798

goodwine@uthscsa.edu

Maggie Tomasini

CONTACT

210 450 5962

tomasinim@uthscsa.edu

Principal Investigator

William Kelly, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center - Mays Cancer Center

Study Locations (Sites)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

William Kelly, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center - Mays Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-25

Study Completion Date2026-09

Study Record Updates

Study Start Date2022-05-25

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Glioblastoma