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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06630416
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • MTAP Deletion
  • Metastatic Bladder Urothelial Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Stage IV Bladder Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Pemetrexed — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Nov 27, 2024
Status verified
Jun 2026
Primary completion
May 10, 2029
Completion
May 10, 2030

Study Design

Enrollment
64 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pemetrexed)
    Patients receive pemetrexed IV over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection on study as well as CT throughout the trial.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: From baseline until the subject experiences disease progression, the subject initiates subsequent anti-cancer therapy, or the subject completes study participation (whichever occurs first), assessed up to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Devalingam Mahalingam, MD, PhD
[email protected]
3126951301
Devalingam Mahalingam, MD, PhD (PRINCIPAL_INVESTIGATOR)
Northwestern Medicine Orland ParkOrland ParkIllinois60462
Study Coordinator
[email protected]
3126951301
Devalingam Mahalingam, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Northwestern University· Chicago, ILNorthwestern Medicine Orland Park· Orland Park, IL

Related Studies