Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3/4)

Launched by LEE'S PHARMACEUTICAL LIMITED · Dec 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called 5-aminolevulinic acid (5-ALA) to see how well it works for patients with certain types of brain tumors known as malignant gliomas (grades 3 and 4). The trial will compare two ways of removing these tumors: one using a special light that can help identify the tumor more clearly and the other using regular white light. The goal is to find out if using 5-ALA improves the surgery's effectiveness and safety for patients.

To participate in this trial, individuals need to be between the ages of 18 and 70 and have a newly diagnosed malignant glioma. They also need to be able to take medications by mouth and have certain lab test results that meet specific criteria. Participants can expect to take the 5-ALA solution before their surgery and then undergo tumor removal with either the fluorescent light or the regular light. It's important to note that not everyone will be eligible; those with certain medical conditions or who have had other treatments recently may not qualify. If you or a loved one is considering this trial, it’s a good idea to discuss it with a healthcare provider to see if it’s a suitable option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males or females 18-70 years of age, inclusive;
• • Patients with presumably new malignant gliomas (WHO grade 3/4) diagnosed by imaging;
• • have a Karnofsky Performance Status (KPS) ≥ 60;
• • Ability to take oral medications;
• * Laboratory tests meeting the following criteria within ≤ 7 days preoperatively:
• • Alanine aminotransferase (ALT), Mentholatum aminotransferase (AST), Glutamyl transpeptidase (GGT) \< 100 IU/L; Serum total bilirubin (TBIL) \< 51.3 μmol/L (3.0 mg/dl); Serum creatinine (CRE) \< 176.8 μmol/L (2.0 mg/dl);
• • Non-surgically sterilized or female subjects of childbearing potential need to have a negative serum pregnancy test result and must be non-lactating females; female subjects of childbearing potential and male subjects whose spouses are of childbearing potential are voluntarily using contraception for a period of 3 months after administration of the test drug;
• • Subjects are able to understand the informed consent form, voluntarily participate and sign the informed consent form, have good compliance, and cooperate with follow-up visits.
• Exclusion Criteria:
• • Known hypersensitivity to the test drug ingredients, aminoglutaric acid, porphyrins, or their analogs;
• • acute or chronic porphyria; history of cutaneous photosensitivity, actinic dermatoses, and exfoliative dermatitis
• • Tumor located in the midline, basal ganglia, cerebellum, or brainstem;
• • Inability to undergo enhanced MRI (pacemaker, contrast allergy, and other reasons);
• • Subjects taking other trial medications within 30 days prior to the start of this trial or subjects undergoing other clinical trials at the same time;
• • Comorbid uncontrolled cardiac conditions such as: a) New York Heart Association (NYHA) class ≥II, b) severe/unstable angina, c) primary cardiomyopathy, d) myocardial infarction or previous coronary/peripheral artery bypass grafting within ≤6 months prior to the procedure, e) difficult-to-control hypertension, f) severe arrhythmia requiring medication or intervention, and g) screening echocardiographic left ventricular ejection fraction \<50%;
• • Active hepatitis B or C (unless HBV-DNA titers below the minimum detection limit and HCV-RNA negative on antiviral therapy can be included), HIV-positive or known history of acquired immunodeficiency syndrome;
• • Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;