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New treatment option for Metastatic Bladder Urothelial Carcinoma
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
ClinicalTrials.gov ID: NCT06630416
What this study is testing
What is Pemetrexed?
Pemetrexed is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic bladder urothelial carcinoma.
Also referred to as MTA, Multitargeted Antifolate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have pathologically or cytologically confirmed metastatic urothelial bladder carcinoma (Arm A) or other metastatic/locally-advanced...
- Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), measured preferably by...
- Patients who have received any prior neoadjuvant or systemic chemotherapy are eligible.
- Notes:
- Patients must have progressive disease despite two prior lines of therapy in the metastatic setting or locally advanced setting unless the patient...
You likely can't join if
- Patients who received prior pemetrexed containing chemotherapy.
- Patients who have had chemotherapy or radiotherapy ≤ 21 days (prior to planned treatment start date). For palliative radiation, 5 day wash out is...
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception...
- Patients who are receiving any other investigational agents. A 21 day wash out period will be required after discontinuation of an investigational...
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed.
- Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:
See the full eligibility criteria
Who can join
- Patients must have pathologically or cytologically confirmed metastatic urothelial bladder carcinoma (Arm A) or other metastatic/locally-advanced solid malignancy (Arm B) and MLL4- protein (KMT2D-gene) or UTX-protein...
- Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), measured preferably by computed tomography (CT) scan.
- Patients who have received any prior neoadjuvant or systemic chemotherapy are eligible.
- Notes:
- Patients must have progressive disease despite two prior lines of therapy in the metastatic setting or locally advanced setting unless the patient was not suitable for an approved second line regimen due to intolerance...
- Treatment cannot have included prior pemetrexed. Any prior intravesical therapy, or immunotherapy is allowed. At least 3 weeks (21 days) wash-out period since prior chemotherapy or radiation therapy or targeted agent is...
- Patients must be aged ≥ 18 years.
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients must have adequate organ and bone marrow function as defined:
- Absolute neutrophil count (ANC) ≥ 1,500/mcL (growth factor allowed and can be added at the discretion of the treating oncologist)
- Hemoglobin (Hgb) ≥ 8.5 g/dL (without the need for transfusion within the previous one week)
- Platelets (PLT) ≥ 100,000/mL (without the need for platelet transfusion within the previous one week)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except people with Gilbert's syndrome or liver metastases, who must have a baseline total bilirubin ≤ 3.0 mg/dL
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) ≤ 3 x institutional ULN or ≤ 5 x ULN if documented liver metastases are present
- Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN or ≤ 5 x ULN if documented liver metastases are present
- Creatinine clearance ≥ 45 mL/min/1.73 m\^2 using the standard Cockcroft and Gault formula
- Patients must have the ability to comply with the administration of supplemental therapies including folic acid, vitamin B12 and steroids as directed by study team and as per standard of care and institutional standards...
- Patients must be able swallow oral medication or not have problems/diseases that affect absorption or oral medication.
- Patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration. Please note this lab is...
- Patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Please note this lab is not a requirement for eligibility...
- Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with a known HCV infection who are currently on treatment, they are eligible if they have an undetectable...
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Pemetrexed is known to be teratogenic. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of...
- Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
- POCBP must have a negative pregnancy test prior to registration on study.
- The ability to interrupt nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin at higher dose (\> 1.3 g per day) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of...
- Patients must be able to understand and voluntarily sign a written informed consent and willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other...
What rules you out
- Patients who received prior pemetrexed containing chemotherapy.
- Patients who have had chemotherapy or radiotherapy ≤ 21 days (prior to planned treatment start date). For palliative radiation, 5 day wash out is sufficient.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia, neuropathy and other non-significant adverse events deemed...
- Patients who are receiving any other investigational agents. A 21 day wash out period will be required after discontinuation of an investigational agent prior to first day of study treatment.
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed.
- Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:
- Ongoing or active infection requiring systemic treatment
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Note: To be eligible for this trial, patients should be class 2B or better
- Patients with presence of third space fluid which cannot be controlled by drainage
- Note: For patients who develop or have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration...
- Has received the final dose of any of the following treatments/ procedures with the specified minimum intervals before first dose of study drug:
- Focal radiation therapy - 7 days
- Surgery with general anesthesia - 7 days
- Surgery with local anesthesia - 3 days
- For palliative radiation - 5 days
- Patients of child bearing (POCB) potential who are pregnant or nursing.
- Note: Registration of patients is completed in Northwestern Oncology Trial Information System (NOTIS)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Orland Park, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Orland Park, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.