Actively Recruiting
Pemetrexed Response in Relation to Tumor Alterations of Gene Status for the Treatment of Patients With Metastatic Urothelial Bladder Cancer and Other Solid Tumors
Led by Northwestern University · Updated on 2026-02-24
64
Participants Needed
2
Research Sites
284 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pemetrexed Response in Relation to Tumor Alterations of Gene Status for the Treatment of Patients With Metastatic Urothelial Bladder Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed metastatic urothelial bladder carcinoma or other metastatic solid tumors with loss of function mutations in MLL4-protein (KMT2D-gene), UTX-protein (KDM6A-gene), or MTAP enzyme
- At least one measurable lesion per RECIST v1.1, preferably by CT scan
- Prior neoadjuvant or systemic chemotherapy allowed, except prior pemetrexed; must have progressive disease despite two prior lines unless unsuitable
- Age 18 years or older
- ECOG performance status 0-2
- Absolute neutrophil count 215000/mcL
- Hemoglobin 218.5 g/dL without recent transfusion
- Platelets 22100,000/mL without recent transfusion
- Total bilirubin 221.5 x institutional ULN (up to 3.0 mg/dL for Gilbert's syndrome or liver metastases)
- AST and ALT 223 x ULN or 225 x ULN if liver metastases present
- Creatinine clearance 2245 mL/min/1.73 m2
- Ability to comply with supplemental therapies (folic acid, vitamin B12, steroids)
- Ability to swallow oral medication without absorption issues
- Controlled HIV, HBV, or HCV infections as specified
- Treated brain metastases without progression
- Agreement to use adequate contraception if of child-bearing potential or with partners of child-bearing potential
- Ability to interrupt NSAIDs/aspirin as required
- Ability to understand and voluntarily consent to study procedures
You will not qualify if you...
- Prior treatment with pemetrexed-containing chemotherapy
- Chemotherapy or radiotherapy within 28 days before starting study
- Unresolved toxicities above grade 1 from prior cancer therapy except certain non-significant events
- Receiving other investigational agents within 28 days
- Allergic reactions to pemetrexed or similar compounds
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina
- Prior or concurrent malignancy interfering with safety or efficacy assessments
- Cardiac disease with New York Heart Association Functional Classification worse than class 2B
- Uncontrolled third space fluid such as pleural or peritoneal effusions
- Recent focal radiation therapy, surgery with general anesthesia within 7 days, or surgery with local anesthesia within 3 days
- Pregnant or nursing patients of child-bearing potential
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
Research Team
S
Study Coordinator, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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