Combining Atorvastatin with Temozolomide for Glioblastoma Treatment

Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma

This study is testing if combining a cholesterol-lowering drug called atorvastatin with a cancer medication called temozolomide can help people with a tough type of brain tumor called glioblastoma feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Tianjin Medical University General Hospital (Academic / other)
• Locations: 1 site (Tianjin)
• Trial ID: NCT06327451 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of atorvastatin, a statin known for its cholesterol-lowering effects, when combined with temozolomide in treating glioblastoma, a highly aggressive brain tumor. The study aims to determine if this combination can improve patient outcomes, particularly given the poor prognosis associated with glioblastoma. Participants will be monitored for their response to treatment and any potential side effects. The trial focuses on patients diagnosed with IDH-wildtype glioblastoma, utilizing MRI scans for confirmation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with a confirmed diagnosis of WHO grade 4 glioblastoma and specific immunohistochemical results.

Not a fit: Patients with allergies to atorvastatin or those currently taking certain contraindicated medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve survival rates and quality of life for glioblastoma patients.

How similar studies have performed: While the combination of statins and chemotherapy is a novel approach in glioblastoma treatment, previous studies have indicated potential anti-tumor effects of statins in various cancers.

Eligibility criteria

Inclusion Criteria:

1. age ≥18 years old and \< 60 years old, both sexes;
2. sufficient evidence of glioma by MRI scan;
3. According to the 2021 WHO latest classification, the molecular pathology of postoperative glioma samples was diagnosed as WHO 4 glioblastoma;
4. The immunohistochemical results of postoperative glioma samples showed that EGFR score was 3 (standard: 0 was negative, 1-3 was positive);
5. normal blood routine and liver function;
6. fully understand the nature of the trial and sign the informed consent;
7. be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
8. no serious diseases or accidents requiring surgery;
9. normal immune function.

Exclusion Criteria:

1. allergy to atorvastatin or its components;
2. concomitant use of clarithromycin, itraconazole, ritonavir, saquinavir, lopinavir, cyclosporine, rifampicin, efavirenz, digoxin, warfarin, oral contraceptives;
3. other tumors (except glioma), hematological diseases or other known multiple organ failure, history of myasthenia gravis, heart failure, cerebral hernia and other serious complications;
4. History of cardiac insufficiency, arrhythmia, retinopathy, acute hepatic porphyrin, hepatic and renal insufficiency, obesity, uncontrolled diabetes and other metabolic diseases;
5. abnormal liver function or liver disease, including uncontrolled hepatitis;
6. other diseases that might interfere with the study, as determined by 2 attending neurosurgeons;
7. patients enrolled in a clinical trial within the past 4 weeks;
8. pregnant or lactating patients;
9. patients with poor compliance who could not complete the treatment;
10. other conditions that made the patient ineligible for enrollment as determined by the study investigator;
11. patients with a history of HIV and/or HBV/HCV or presence of HIV/HCV;
12. patients with a history of tuberculosis or known existence of tuberculosis;
13. patients with severe infection or signs/symptoms of infection within 2 weeks before the first dose of study drug;
14. patients who received live attenuated vaccine within 4 weeks before the first dose of study drug;
15. patients with previous solid organ transplantation or hematopoietic stem cell transplantation.

Those who meet any of the above criteria will not be selected.

Where this trial is running

Tianjin

• Tianjin Medical University General Hospital — Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Chunsheng Kang — Tianjin Medical University General Hospital
• Study coordinator: Chunsheng Kang

Conditions Glioblastoma, IDH-wildtype