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MEK Inhibitor

Trametinib with/without Radiation for Brain Metastasis

Q: To what extent can Trametinib be detrimental to patient health?

As this is the initial Phase 1 trial, there is limited evidence regarding Trametinib's safety and efficacy. Therefore, our team estimates its level of security to be a score of 1 out of 3.

Q: What is the current limit for enrolment in this research endeavor?

This clinical trial has since concluded its recruitment phase. It was initially posted on August 1st 2014 and last edited October 15th 2022. Alternatively, there are 2691 trials for <a href="https://www.withpower.com/clinical-trials/brain-cancer">brain cancer</a> that remain open to participants as well as 92 studies involving Trametinib with active enrollment procedures.

Q: Is there still an opportunity for volunteers to partake in this research?

At the present moment, this clinical trial is not enrolling any new participants. This experiment was first posted on August 1st 2014 and last revised October 15th 2022. If you're seeking other trials, there are 2691 studies with open enrollment particularly related to <a href="https://www.withpower.com/clinical-trials/brain-cancer">brain cancer</a> and 92 for Trametinib specifically.

Q: What precedent exists for research regarding Trametinib?

Presently, there are 92 active studies for Trametinib with 6 of them at Phase 3. While Saint Louis, <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a> is the hub for many clinical trials involving this drug, it can be accessed in 5794 locations across the globe.

Q: To what end is this research experiment seeking to attain?

The primary purpose of the trial, to be supervised over a 28 day period is to determine the maximum dose level of trametinib that results in 1 out 6 patients experiencing DLTs. Secondary objectives are neurological progression-free survival described by Kaplan and Meier's methods, proportion of compliant patients measured as tolerance metric, and objective response rate estimated using Response Evaluation Criteria for Solid Tumours with 95% binomial confidence intervals calculated.

Phase 1

Waitlist Available

Led By Joshua D Palmer

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) =< grade 1 (except alopecia) at the time of enrollment

Histologically confirmed cancer with measurable or evaluable brain metastases by computed tomography (CT) or magnetic resonance imaging (MRI); MRI is preferred, but a CT scan is acceptable for patients that are unable to have an MRI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing the effects of a drug called trametinib, with or without radiation therapy, in patients with brain metastases. Trametinib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving trametinib with radiation therapy may be a better treatment for brain metastases.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include skin rash, diarrhea, fatigue, swelling in parts of the body due to fluid retention (edema), shortness of breath, coughing up blood (hemoptysis), high blood pressure (hypertension), and decreased ejection fraction indicating potential heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My blood tests for liver and kidney function are within normal ranges.

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I can take pills and don't have major stomach or bowel issues affecting drug absorption.

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I am fully active or can carry out light work.

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My heart pumps well, with an ejection fraction of 50% or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of dose-limiting toxicities (DLT), defined as the maximum dose level of trametinib where at most 1 of 6 patients experience DLT (Cohort A)

Quantification of trametinib in resected brain metastatic lesions utilizing high performance liquid chromatography/tandem mass spectrometry (Cohort B)

Secondary outcome measures

Local control rate

Neurologic progression-free survival

Objective response rate per Response Evaluation Criteria in Solid Tumors

+3 more

Other outcome measures

Quantification of cyclin D1, p27, pERK-1/2, pAKT, PTEN, pMTOR, pS6K, and pS6 of resected metastatic brain lesions via immunohistochemistry

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

Trametinib

2014

Completed Phase 2

~1550

Whole-Brain Radiotherapy

2012

Completed Phase 2

~150

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,657 Total Patients Enrolled

Joshua D PalmerPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Brain Metastasis Clinical Trial 2023: Trametinib Highlights & Side Effects. Trial Name: NCT02015117 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Trametinib be detrimental to patient health?

"As this is the initial Phase 1 trial, there is limited evidence regarding Trametinib's safety and efficacy. Therefore, our team estimates its level of security to be a score of 1 out of 3."

Answered by AI

What is the current limit for enrolment in this research endeavor?

"This clinical trial has since concluded its recruitment phase. It was initially posted on August 1st 2014 and last edited October 15th 2022. Alternatively, there are 2691 trials for brain cancer that remain open to participants as well as 92 studies involving Trametinib with active enrollment procedures."

Answered by AI

Is there still an opportunity for volunteers to partake in this research?

"At the present moment, this clinical trial is not enrolling any new participants. This experiment was first posted on August 1st 2014 and last revised October 15th 2022. If you're seeking other trials, there are 2691 studies with open enrollment particularly related to brain cancer and 92 for Trametinib specifically."

Answered by AI

What precedent exists for research regarding Trametinib?

"Presently, there are 92 active studies for Trametinib with 6 of them at Phase 3. While Saint Louis, Missouri is the hub for many clinical trials involving this drug, it can be accessed in 5794 locations across the globe."

Answered by AI

To what end is this research experiment seeking to attain?

"The primary purpose of the trial, to be supervised over a 28 day period is to determine the maximum dose level of trametinib that results in 1 out 6 patients experiencing DLTs. Secondary objectives are neurological progression-free survival described by Kaplan and Meier's methods, proportion of compliant patients measured as tolerance metric, and objective response rate estimated using Response Evaluation Criteria for Solid Tumours with 95% binomial confidence intervals calculated."

Answered by AI

Recent research and studies

Radiotherapy and OncologyJournal

Phase I Study of Trametinib in Combination with Whole Brain Radiation Therapy for Brain Metastases

Palmer, Joshua D., Rahul N. Prasad, Denise Fabian, Lai Wei, Vedat O. Yildiz, Yubo Tan, John Grecula, et al.. 2022. “Phase I Study of Trametinib in Combination with Whole Brain Radiation Therapy for Brain Metastases”. Radiotherapy and Oncology. Elsevier BV. doi:10.1016/j.radonc.2022.03.016.

clinicaltrials.govStudy

Trametinib With or Without Whole Brain Radiation Therapy in Treating Patients With Brain Metastases

2014. "Trametinib With or Without Whole Brain Radiation Therapy in Treating Patients With Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02015117.

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