Combining immune checkpoint inhibitors with intrathecal pemetrexed for leptomeningeal metastasis

Immune Checkpoint Inhibitor Combined With Pemetrexed Intrathecal Injection for Leptomeningeal Metastasis From Solid Tumors: a Phase I/II Study

This study is testing a new treatment that combines an immune therapy with a special injection for patients with cancer that has spread to the lining of the brain and spinal cord to see if it helps them feel better and live longer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou Medical University (Academic / other)
• Locations: 1 site (Huizhou, Guangdong)
• Trial ID: NCT06462222 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm phase I/II trial investigates the combination of an immune checkpoint inhibitor and pemetrexed administered via intrathecal injection for patients with leptomeningeal metastasis from solid tumors. The study aims to determine the recommended dose and assess safety by monitoring adverse events. Participants will be evaluated for clinical response rates, disease control rates, and overall survival. Additionally, cerebrospinal fluid and blood samples will be collected to identify potential predictors of treatment efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed solid tumors and positive cerebrospinal fluid cytopathology.

Not a fit: Patients with severe nervous system diseases or extensive progressive systemic diseases without effective treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for patients with leptomeningeal metastasis, potentially improving survival and quality of life.

How similar studies have performed: While the combination of immune checkpoint inhibitors and intrathecal chemotherapy is a novel approach, similar studies have shown promise in treating other forms of cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.
2. Male or female aged between 18 and 75 years; Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
3. No history of severe nervous system disease; No severe dyscrasia.

Exclusion Criteria:

1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.
4. Patients with poor compliance or other reasons that were unsuitable for this study.

Where this trial is running

Huizhou, Guangdong

• The Affiliated Huizhou Hospital, Guangzhou Medical University — Huizhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Zhenyu Pan

Conditions Leptomeningeal Metastasis; Leptomeningeal metastasis; Intrathecal chemotherapy; Immune checkpoint inhibitor; Pemetrexed