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Pemetrexed for Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen byDevalingam Mahalingam, MBBChBAO

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Northwestern University

Must be taking: Folic acid, Vitamin B12, Steroids

Must not be taking: Investigational agents

Disqualifiers: Prior pemetrexed, Uncontrolled illness, Cardiac disease, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must stop taking nonsteroidal anti-inflammatory drugs (NSAIDs) or high-dose aspirin around the time of pemetrexed treatment. There is also a 28-day washout period required after stopping any prior chemotherapy, radiation, or investigational agents before starting the trial.

What data supports the effectiveness of the drug Pemetrexed for bladder cancer?

Pemetrexed has shown effectiveness in treating various solid tumors, including bladder cancer, and has a favorable response rate of about 30% in advanced urothelial carcinoma with minimal side effects. It is also effective when combined with other drugs like gemcitabine and cisplatin for treating advanced urothelial cancer.¹ ² ³ ⁴ ⁵

Is Pemetrexed generally safe for humans?

Pemetrexed has been used to treat various cancers and is generally considered safe when kidney function is normal, but it can cause kidney damage, skin changes, and rashes in some people.¹ ² ⁵ ⁶ ⁷

How is the drug Pemetrexed unique for treating bladder cancer?

Pemetrexed is unique because it is a multitargeted antifolate that works by blocking several enzymes needed for cancer cell growth, and it has shown effectiveness in a variety of solid tumors, including bladder cancer. It can be used alone or in combination with other drugs like cisplatin, offering a favorable response rate with minimal toxicity.¹ ² ⁴ ⁵ ⁸

Research Team

Devalingam Mahalingam, MBBChBAO

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for patients with metastatic urothelial bladder cancer and other solid tumors that have spread, who also have specific genetic mutations (loss of function in MLL4-protein/KMT2D-gene or UTX-protein/KDM6A-gene or MTAP enzyme). Details on inclusion and exclusion criteria are not provided.

Inclusion Criteria

Patients of child-bearing potential and their partners must agree to adequate contraception

Patients must be able to understand and sign a written informed consent

Patients must have the ability to comply with supplemental therapies

See 11 more

Exclusion Criteria

Patients with uncontrolled intercurrent illnesses

Patients who received specified treatments/procedures within minimum intervals before study drug

Patients receiving other investigational agents

See 8 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive pemetrexed intravenously over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

21 days per cycle

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 3 months for up to 12 months.

12 months

4 visits (in-person)

Treatment Details

Interventions

Pemetrexed (Anti-metabolites)

Trial OverviewThe trial is testing the effectiveness of Pemetrexed, a medication that inhibits tumor cells from using folic acid to create DNA, potentially killing them. It's aimed at improving treatment response in patients with certain genetic alterations.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (pemetrexed)Experimental Treatment3 Interventions

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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Northwestern UniversityChicago, IL

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Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1674

Patients Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief communication: use of the multitargeted antifolate pemetrexed (Alimta) in genitourinary cancer.Misset, JL.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer: the PECULIAR study (KCSG 10-17).Choi, YJ., Lee, SH., Lee, JL., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 trial of pemetrexed disodium and gemcitabine in advanced urothelial cancer (E4802): a trial of the Eastern Cooperative Oncology Group.Dreicer, R., Li, H., Cooney, MM., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical studies of pemetrexed and gemcitabine combinations.Adjei, AA.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pemetrexed induced acute kidney injury in patients with non-small cell lung cancer: reversible and chronic renal damage.Rombolà, G., Vaira, F., Trezzi, M., et al.[2021]

Pemetrexed, a treatment for malignant pleural mesothelioma and non-small cell lung cancer, has been associated with a new toxicity resembling scleroderma, as seen in two cases involving painful induration and edema of the lower extremities.

This adverse effect can be mistaken for erysipelas due to similar symptoms, but it lacks fever; recognizing this toxicity is crucial for timely diagnosis and management, and folate and vitamin B12 supplementation may help reduce its incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pemetrexed-induced scleroderma-like changes in the lower legs].Corbaux, C., Marie, J., Meraud, JP., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pemetrexed-associated urticarial vasculitis.Lopes, G., Vincek, V., Raez, LE.[2015]

Pemetrexed disodium (Alimta) was the first drug approved by the US FDA in February 2004 for treating malignant pleural mesothelioma, a rare cancer, highlighting its significance in oncology.

In August 2004, pemetrexed also received accelerated approval for use as a second-line treatment for non-small-cell lung cancer, demonstrating its efficacy in targeting folate-dependent processes crucial for cancer cell growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pemetrexed disodium.Gibbs, D., Jackman, A.[2019]