Combining Temozolomide with 6-MP for treating recurrent glioblastoma

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

This study is testing if combining two medications, Temozolomide and 6-mercaptopurine, can help people with recurrent glioblastoma feel better when other treatments haven't worked.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06279767 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of combining Temozolomide (TMZ) with 6-mercaptopurine (6-MP) in patients suffering from recurrent glioblastoma, a highly aggressive brain tumor. The study aims to evaluate how this combination therapy can improve outcomes for patients who have not responded to standard treatments. Participants will be closely monitored for their response to the treatment and any potential side effects. The trial includes patients aged 18 to 65 with confirmed recurrent glioblastoma and measurable tumor lesions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with histologically confirmed recurrent glioblastoma who have not previously received 6-mercaptopurine.

Not a fit: Patients who have not consented to participate or have severe internal diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent glioblastoma, potentially improving survival rates.

How similar studies have performed: While the combination of TMZ and 6-MP has not been extensively tested together, the use of TMZ as a standard treatment has shown success in glioblastoma management.

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.

Where this trial is running

Nanjing, Jiangsu

• Department of Neurosurgery of The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Yongping You, DD

Conditions Glioblastoma; Cancer; Temozolomide; 6-mercaptopurine