Actively Recruiting
A Phase II Trial to Evaluate Pemetrexed Response in Relation to Tumor Gene Alterations in Previously Treated Metastatic Urothelial Carcinoma and Other Solid Tumors
Led by Northwestern University · Updated on 2026-02-24
64
Participants Needed
2
Research Sites
52 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
Researchers are evaluating how well the drug pemetrexed works in treating patients with metastatic urothelial bladder cancer and other metastatic solid tumors that have specific genetic mutations causing loss of function in the MLL4-protein/KMT2D-gene, UTX-protein/KDM6A-gene, or MTAP enzyme. These mutations reduce or eliminate gene activity and are found in various cancers including bladder, esophageal, endometrial, and esophagogastric cancers. This phase II trial aims to understand pemetrexed's overall response rate, progression-free survival, overall survival, duration of response, and safety in this patient group. Patients receive pemetrexed intravenously over 10 minutes on the first day of each 21-day treatment cycle. Treatment continues until the disease progresses or unacceptable side effects occur. Throughout the trial, patients will have blood and urine samples collected and undergo computed tomography (CT) scans to monitor their condition. After completing treatment, patients will be followed up every three months for up to one year to assess long-term outcomes. Participants will be regularly evaluated using CT scans and laboratory tests including blood and urine samples. Researchers will track the overall response to treatment, time until disease progression or death, and any adverse effects over a period of up to 12 months. Safety and tolerability of pemetrexed are closely monitored, and additional samples may be collected to study resistance mechanisms. The total participation time includes treatment cycles and follow-up visits extending up to one year after treatment completion.
CONDITIONS
Brief 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 must have confirmed metastatic urothelial bladder carcinoma or other metastatic solid tumors with specific gene mutations (MLL4/KMT2D, UTX/KDM6A, or MTAP loss of function).
- Patients must have at least one measurable tumor lesion by RECIST v1.1, preferably via CT scan.
- Patients may have had prior neoadjuvant or systemic chemotherapy but no prior pemetrexed treatment.
- Patients must have progressive disease after two prior metastatic therapies or be unsuitable for second-line therapy due to intolerance.
- Patients must be 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate blood counts: ANC ≥ 1,500/mcL, Hemoglobin ≥ 8.5 g/dL, Platelets ≥ 100,000/mL without recent transfusions.
- Liver and kidney function within specified limits.
- Ability to take supplemental folic acid, vitamin B12, and steroids as directed.
- Ability to swallow oral medications or no absorption issues.
- Patients with controlled HIV, hepatitis B or C infections as specified.
- Patients with treated brain metastases without progression.
- Patients of child-bearing potential and their partners must agree to use contraception during and after treatment.
- Ability to interrupt NSAIDs or aspirin around treatment.
- Ability to understand and voluntarily sign informed consent and comply with study procedures.
You will not qualify if you...
- Prior treatment with pemetrexed chemotherapy.
- Chemotherapy or radiotherapy within 28 days before starting treatment.
- Unresolved adverse events from prior cancer therapy greater than grade 1, except certain non-significant events.
- Use of other investigational agents without a 28-day washout.
- History of allergic reactions to compounds similar to pemetrexed.
- Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, or other safety concerns.
- Other malignancies that could interfere with safety or treatment assessment.
- Cardiac disease history requiring assessment; must have New York Heart Association Class 2B or better.
- Uncontrolled fluid buildup that cannot be drained.
- Recent focal radiation therapy or surgery within specified timeframes.
- Pregnancy or nursing in patients of child-bearing potential.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive pemetrexed intravenously over 10 minutes on day 1 of each 21-day cycle. Blood and urine samples are collected, and CT scans are performed throughout the treatment period to monitor tumor response and safety.
1 visit every 21 days per cycle
Duration - Up to 12 months
After completing treatment, participants are followed up every 3 months for up to 12 months to monitor their health and collect additional data.
Visits every 3 months for up to 12 months
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here