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

Who is this study for? Patients with Glioblastoma
What treatments are being studied? Lomustine+Imipramine Hydrochloride
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Mays Cancer Center, UT Health San Antonio
RECRUITING
San Antonio
Contact Information
Primary
Epp Goodwin
goodwine@uthscsa.edu
210 450 5798
Backup
Maggie Tomasini
tomasinim@uthscsa.edu
210 450 5962
Time Frame
Start Date: 2022-05-25
Estimated Completion Date: 2026-11
Participants
Target number of participants: 25
Treatments
Experimental: Imipramine Hydrochloride/Lomustine
Sponsors
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov