Lumbar Punctures for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByJoshua D Palmer, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I trial assesses the use of lumbar punctures to detect whether there is circulating tumor deoxyribonucleic acid (ctDNA) in the fluid that surrounds the brain and spinal cord (cerebrospinal fluid) in patients with stage III and IV non-small cell lung cancer (NSCLC). Patients with stage III and IV NSCLC are at risk of having their cancer spread from where it first started to the brain (metastatic). Because of this, more effective prognostic tools are necessary to determine which stage III and IV NSCLC patients are more likely to develop brain metastases. Cerebrospinal fluid (CSF) could be a reliable source of ctDNA to confirm and predict the presence of brain metastases in these patients. Assessing cell free DNA shed from tumor cells could be a sensitive and minimally invasive way to detect or characterize metastatic tumors in the central nervous system (CNS). Lumbar puncture is procedure in which a thin needle called a spinal needle is put into the lower part of the spinal column to collect CSF. Lumbar punctures for the collection of CSF may help doctors detect or measure changes in cell types, genes, and proteins of circulating tumor cells related to lung cancer that will help determine the presence of brain metastases which could become a standard of care screening tool utilized in the follow-up of patients diagnosed with stage II or IV NSCLC.

Eligibility Criteria

This trial is for patients with advanced non-small cell lung cancer (stages III and IV). It's designed to see if a procedure called lumbar puncture can detect tumor DNA in spinal fluid, which might help predict brain metastases. Participants should be at risk of their cancer spreading to the brain.

Inclusion Criteria

My lung cancer is at an advanced stage (III or IV).

My advanced lung cancer has a specific mutation identified by a test.

I received radiation or systemic therapy at Ohio State University.

I can safely undergo a lumbar puncture.

Exclusion Criteria

I cannot undergo an MRI scan.

I am not pregnant or breastfeeding and willing to use contraception.

Participant Groups

The study is testing whether lumbar punctures can find circulating tumor DNA in cerebrospinal fluid as a way to foresee brain metastasis in stage III and IV NSCLC patients. The trial includes MRI scans and biospecimen collection for analysis.

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Stage IV NSCLC with brain metastases (LP)Experimental Treatment3 Interventions

Patients undergo LP for collection of CSF and blood sample collection on study. Patients also undergo MRI during screening. Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.

Group II: Cohort 1: Stage III/IV without brain metastases (LP)Experimental Treatment3 Interventions

Patients undergo LP for collection of CSF and blood sample collection after completion of chemoradiotherapy (stage III) or after diagnosis (stage IV) on study. Patients also undergo MRI during screening and 12 month follow-up. Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.