Study on Pemetrexed for Treating Metastatic Urothelial Bladder Cancer and Other Solid Tumors with Specific Gene Changes

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06630416

Provider View

This clinical trial is exploring how well the drug pemetrexed works in treating patients with metastatic urothelial bladder cancer and other solid tumors that have specific genetic changes affecting certain proteins or enzymes.

Patient Parameters

Program Overview

The purpose of this study is to see if the drug pemetrexed can effectively treat patients with urothelial bladder cancer and other solid tumors that have spread to other parts of the body. The study focuses on tumors with specific genetic changes that affect the MLL4-protein/KMT2D-gene, UTX-protein/KDM6A-gene, or MTAP enzyme. These changes can reduce or stop the normal function of these genes. Pemetrexed is a type of medication that stops cancer cells from using folic acid to make DNA, which may help kill tumor cells. The study aims to find out if pemetrexed can improve treatment responses in these patients.

Description

The main goal of this study is to determine how well pemetrexed works in shrinking tumors in patients with metastatic solid tumors that have specific genetic changes. Researchers will also look at how long patients live without the cancer getting worse, overall survival rates, and how long the response to treatment lasts. The safety and side effects of pemetrexed will also be assessed.

Patients in the study will receive pemetrexed through an IV every 21 days, as long as the cancer does not progress or cause unacceptable side effects. Blood and urine samples will be collected, and CT scans will be performed throughout the trial to monitor the cancer.

After finishing the study treatment, patients will have follow-up visits every three months for up to a year to check on their health and the status of their cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of metastatic urothelial bladder cancer or another metastatic solid tumor with specific genetic changes affecting the MLL4-protein/KMT2D-gene, UTX-protein/KDM6A-gene, or MTAP enzyme.
  • Have at least one measurable tumor that can be tracked using standard criteria.
  • Have previously received chemotherapy but the cancer has progressed despite treatment, unless unable to tolerate a second line of treatment.
  • Be 18 years or older.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1,500/mcL.
    • Hemoglobin level of at least 8.5 g/dL.
    • Platelet count of at least 100,000/mL.
    • Normal liver and kidney function as indicated by specific blood tests.
  • Be able to take additional supplements and medications as required by the study.
  • Be able to swallow oral medication.
  • Have controlled HIV, hepatitis B, or hepatitis C infections if applicable.
  • Have treated brain metastases with no evidence of progression.
  • Agree to use effective contraception during the study and for 180 days after treatment if of childbearing potential.
  • Be able to understand and sign a written informed consent and comply with study requirements.

Exclusion Criteria

  • Have received prior treatment with pemetrexed.
  • Have had chemotherapy or radiotherapy within 28 days before starting the study treatment.
  • Have not recovered from side effects of previous cancer treatments, except for certain non-significant side effects.
  • Are currently receiving other investigational treatments.
  • Have a history of allergic reactions to similar drugs.
  • Have uncontrolled illnesses, such as active infections or heart conditions, that could interfere with the study.
  • Have another cancer that could affect the study results.
  • Have significant fluid buildup in the body that cannot be controlled.
  • Have had recent surgery or radiation therapy within specified timeframes before starting the study.
  • Are pregnant or nursing.

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