RecruitingPhase 2NCT06630416

Pemetrexed Response in Relation to Tumor Alterations of Gene Status for the Treatment of Patients With Metastatic Urothelial Bladder Cancer and Other Solid Tumors

A Phase II Trial to Evaluate Pemetrexed Response in Relation to Tumor Alterations of Gene Status in Patients With Previously Treated Metastatic Urothelial Carcinoma and Other Solid Tumors


Sponsor

Northwestern University

Enrollment

64 participants

Start Date

Nov 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well pemetrexed works in treating patients with urothelial bladder cancer and other solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) with mutations that result in a loss of function in the MLL4-protein/KMT2D-gene or UTX-protein/KDM6A-gene or MTAP enzyme. Loss of function due to a genetic mutation means a gene's activity may be reduced or eliminated. Mutations that result in a loss of function in the MLL4-protein or KMT2D-gene are found in 9.96% of all cancers including bladder carcinoma patients, esophageal squamous cell carcinoma and esophageal adenocarcinoma patients. In addition, mutations that result in a loss of function in the UTX-protein or KDM6A-gene are found in approximately 5% of all tumors, including bladder cancers, endometrial cancer, and esophagogastric cancer amongst many other tumor types. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Giving pemetrexed may increase response in patients with metastatic urothelial bladder cancer and other solid tumors with the loss of function in the MLL4-protein/KMT2D-gene or UTX-protein/KDM6A-gene or MTAP enzyme.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a chemotherapy drug called pemetrexed works better in people whose tumors have specific gene changes (in genes called MLL4/KMT2D, UTX/KDM6A, or MTAP). Participants may have metastatic bladder cancer or other advanced solid cancers. **You may be eligible if...** - You are 18 or older - You have metastatic bladder (urothelial) cancer or another metastatic solid cancer with the specific gene mutations described - You have at least one measurable tumor on scans - You have already received at least two prior treatments (for bladder cancer), or progressed after standard therapy - You have not previously received pemetrexed **You may NOT be eligible if...** - You have previously received pemetrexed - You have uncontrolled heart disease or active serious infections - You have third-space fluid collections (such as uncontrolled pleural effusion or ascites) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiospecimen Collection

Undergo blood and urine sample collection

PROCEDUREComputed Tomography

Undergo CT

DRUGPemetrexed

Given IV


Locations(2)

Northwestern University

Chicago, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06630416


Related Trials