Trametinib with/without Radiation for Brain Metastasis

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

10 Participants Needed

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.

Research Team

Joshua D. Palmer, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive trametinib orally once daily. In Cohort A, 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. In Cohort B, patients receive trametinib for 14 days followed by surgical resection of the tumor.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up occurs every 2 months for 1 year, every 3 months for 3 years, and then every 6 months thereafter.

Long-term

Treatment Details

Interventions

• Trametinib
• Whole-Brain Radiotherapy

Trial Overview 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.

Participant Groups

Group I: Cohort B (trametinib, surgery) Experimental Treatment 4 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 Treatment 4 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:

• Melanoma
• Non-small cell lung cancer

Approved in United States as Mekinist for:

• Melanoma
• Non-small cell lung cancer
• Thyroid cancer

Approved in Canada as Mekinist for:

• Melanoma
• Non-small cell lung cancer

Approved in Japan as Mekinist for:

• Melanoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+