Trametinib with/without Radiation for Brain Metastasis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJoshua D. Palmer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of trametinib with or without whole brain radiation therapy in treating patients with brain metastases. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs, such as trametinib, may make tumor cells more sensitive to radiation therapy. Giving trametinib with whole brain radiation therapy may be a better treatment for brain metastases.

Eligibility Criteria

This trial is for patients with brain metastases who can swallow pills, have no significant gastrointestinal issues affecting drug absorption, and meet specific blood count requirements. They must not need urgent neurologic treatment, have a history of certain lung or heart conditions, or be on conflicting medications. Women must test negative for pregnancy and use contraception; men also agree to contraception.

Inclusion Criteria

All my previous treatment side effects are mild, except for hair loss.

My cancer has spread to my brain, confirmed by a CT or MRI scan.

My blood clotting tests are normal or I'm on warfarin.

+8 more

Exclusion Criteria

I have had cancer before, making it unclear if my brain metastases come from a new or old cancer.

I cannot stay still for brain radiation treatment.

My cancer has spread to the lining of my brain and spinal cord.

+16 more

Participant Groups

The study is testing the effects and optimal dosage of trametinib alone or combined with whole-brain radiation therapy in treating brain tumors. Trametinib blocks enzymes that promote tumor growth while radiation aims to kill tumor cells directly.

2Treatment groups

Experimental Treatment

Group I: Cohort B (trametinib, surgery)Experimental Treatment4 Interventions

Patients receive trametinib PO QD on days 1-14 followed by surgical resection of the tumor.

Group II: Cohort A (trametinib, whole-brain radiation therapy)Experimental Treatment4 Interventions

Patients receive trametinib PO QD for 4 weeks. Beginning in week 2, patients undergo whole brain radiation therapy five days a week for 3 weeks. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

Trametinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Mekinist for: