Selumetinib + Cyclosporine for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose and understand the side effects of combining selumetinib and cyclosporine for treating colorectal cancer and other solid tumors that have spread and resist existing treatments. Selumetinib, a targeted therapy, may stop tumor growth by blocking certain enzymes, while cyclosporine, a biological therapy, can influence the immune system and also inhibit tumor growth. This trial may suit those with advanced colorectal cancer who have not responded to standard treatments and have tumors that can be safely biopsied. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have had chemotherapy or radiotherapy within 4 weeks before the study or if you are on certain investigational agents. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that patients with advanced solid tumors generally tolerate the combination of selumetinib and cyclosporine well. In earlier studies, patients experienced manageable side effects, suggesting that severe reactions are uncommon. Evidence also indicates that this treatment is effective against certain types of cancer, which is encouraging.
This trial is in its early stages, specifically Phase 1, which primarily focuses on assessing safety and determining the optimal dose. While early results are positive regarding treatment tolerance, the complete safety profile is still under development. Participants should understand that more detailed safety information will emerge as more patients join the study.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for colorectal cancer, which often include chemotherapy and targeted therapies like bevacizumab or cetuximab, the combination of selumetinib and cyclosporine offers a novel approach. Selumetinib is a MEK inhibitor, which targets a specific pathway (the MAPK/ERK pathway) that plays a key role in cancer cell growth. Cyclosporine, typically known for its use in preventing organ transplant rejection, has properties that may enhance the efficacy of selumetinib by modulating drug resistance mechanisms. Researchers are excited about this combo because it tackles the cancer from a new angle, potentially overcoming resistance issues and improving treatment outcomes.
What evidence suggests that selumetinib and cyclosporine might be an effective treatment for colorectal cancer?
This trial will evaluate the combination of selumetinib and cyclosporine for treating colorectal cancer. Research has shown that this combination may help treat colorectal cancer and other solid tumors. Selumetinib blocks certain enzymes that tumors need to grow and has proven effective in lab studies, especially for cancers with specific genetic changes like BRAF or KRAS. Cyclosporine affects the immune system, and when combined with selumetinib, it has shown promise in models that mimic human cancer. Early results suggest that using both drugs together might be more effective than using each one alone. While more research is needed, these initial findings offer hope for people with colorectal cancer.13678
Who Is on the Research Team?
Christopher H Lieu
Principal Investigator
University of Texas MD Anderson Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors or colorectal cancer that's spread and can't be treated or controlled. They must have had certain treatments, not have specific mutations, and be healthy enough overall (good organ function, no severe heart conditions). Participants need to consent, use contraception if needed, and have a life expectancy over 3 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive selumetinib and cyclosporine orally in a dose-escalation study. Selumetinib is given twice daily starting on day -7 of course 1, and cyclosporine is given twice daily starting on day -3 of course 1. Both drugs are then administered on days 1-28 of each 28-day cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, including assessment of adverse events and progression-free survival.
What Are the Treatments Tested in This Trial?
Interventions
- Cyclosporine
- Selumetinib
Cyclosporine is already approved in European Union, United States, Canada, Japan for the following indications:
- Prevention of organ rejection in kidney, liver, heart, lung, pancreas, and bone marrow transplants
- Treatment of severe psoriasis
- Treatment of nephrotic syndrome
- Prevention of organ rejection in kidney, liver, and heart transplants
- Treatment of severe rheumatoid arthritis
- Treatment of severe psoriasis
- Prevention of organ rejection in kidney, liver, heart, lung, pancreas, and bone marrow transplants
- Treatment of severe psoriasis
- Treatment of nephrotic syndrome
- Prevention of organ rejection in kidney, liver, and heart transplants
- Treatment of severe rheumatoid arthritis
- Treatment of severe psoriasis
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor