Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with recurrent glioblastoma, a type of brain cancer that can return even after standard treatments. The researchers are exploring the safety and effectiveness of combining two medications: temozolomide (TMZ), which is already used for treating glioblastoma, and 6-mercaptopurine (6-MP), which may help make the cancer cells more sensitive to TMZ. The goal is to improve how well patients respond to treatment and potentially extend their survival.

To participate in this trial, you need to be between 18 and 65 years old and have been diagnosed with recurrent glioblastoma after undergoing surgery and other standard treatments. You should also have at least one measurable tumor that can be evaluated through imaging. Participants will complete regular follow-ups and need to provide consent to join the study. This trial is currently recruiting participants and aims to offer hope for better treatment options for those affected by this challenging disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 65, no gender restrictions.
• • 2. Histologically confirmed glioblastoma as the primary tumor after surgery.
• • 3. Patients with recurrent glioblastoma confirmed by MRI after standard treatment (surgery, Stupp regimen) failure, supported by RANO criteria evaluation.
• • 4. At least one measurable intracranial tumor lesion according to RANO criteria.
• • 5. No prior treatment with 6-mercaptopurine or similar drugs.
• • 6. General condition assessed by Karnofsky Performance Status (KPS) score ≥ 60.
• • 7. Normal bone marrow function: white blood cell count ≥ 3.5 × 10\^9/L, neutrophil count ≥ 2.0 × 10\^9/L, hemoglobin count ≥ 90 g/L, platelet count ≥ 80 × 10\^9/L.
• • 8. Normal organ functions such as heart and lung, and no severe internal diseases.
• • 9. Willing to sign an informed consent form, good compliance, able to attend regular follow-ups, and voluntarily agree to comply with the study protocol.
• Exclusion Criteria:
• • 1. Participants who do not consent.
• • 2. Vulnerable populations such as pregnant women, children, and adolescents.
• • 3. No history of or concurrent malignancy within the past 5 years.
• • 4. Abnormal liver function (total bilirubin \> 1.5 times the upper limit of normal, ALT/AST \> 2 times the upper limit of normal).
• • 5. Impaired kidney function (serum creatinine \> 1.5 times the upper limit of normal).
• • 6. Presence of organic heart disease leading to clinical symptoms or cardiac dysfunction (NYHA ≥ Grade 2).
• • 7. Factors significantly affecting oral drug absorption, such as difficulty swallowing, intestinal obstruction, etc.