Study on Imipramine Hydrochloride and Lomustine for Recurrent Glioblastoma
Sponsor: The University of Texas Health Science Center at San Antonio
ClinicalTrials ID:NCT04863950
This clinical trial is exploring the use of two drugs, Imipramine Hydrochloride and Lomustine, to treat patients with glioblastoma that has returned after initial treatment. The study includes both surgical and non-surgical participants.
Patient Parameters
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Program Overview
This study is being conducted at a single center and involves patients with recurrent glioblastoma, a type of brain cancer. The trial is open-label, meaning both the researchers and participants know which treatment is being administered. It aims to evaluate the effectiveness of combining Imipramine Hydrochloride and Lomustine in treating this condition.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must understand the study's purpose and risks and sign a consent form.
- Must have a confirmed diagnosis of glioblastoma.
- Cancer must have progressed after standard treatment with radiation and temozolomide.
- Must have a performance status score of 2 or less, indicating ability to carry out light work.
- Must have a life expectancy of at least 3 months.
- Must have acceptable liver function, with specific limits on bilirubin and liver enzymes.
- Must have acceptable kidney function, with normal serum creatinine levels.
- Must have adequate blood cell counts, including neutrophils, platelets, and hemoglobin.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception. Men must also agree to use contraception during the study and for 6 months after the last dose.
Exclusion Criteria
- Cannot be taking warfarin or similar medications unless switched to low molecular weight heparin.
- Cannot have active bleeding in the brain or tumor, unless it is resolving or minor.
- Cannot undergo MRI scans due to medical devices like pacemakers.
- Cannot have taken certain anti-seizure medications recently.
- Must have recovered from previous treatment side effects to a mild level.
- Cannot have open wounds or be pregnant or breastfeeding.
- Cannot have a history of serious heart conditions or prolonged QT interval on an ECG.
- Cannot have uncontrolled high blood pressure or other serious illnesses.
- Cannot have had certain types of radiation or chemotherapy recently.
- Cannot have a history of severe mental health issues or be taking certain psychiatric medications.
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