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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02015117
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo surgical resection of the tumor
  • Trametinib — DRUG
    Given PO
  • Whole-Brain Radiotherapy — RADIATION
    Undergo whole-brain radiation therapy

Study Details

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.

Key Dates

Start date
Apr 28, 2014
Status verified
Mar 2026
Primary completion
Jul 10, 2020
Completion
Oct 8, 2026

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (trametinib, whole-brain radiation therapy)
    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.
  • Experimental: Cohort B (trametinib, surgery)
    Patients receive trametinib PO QD on days 1-14 followed by surgical resection of the tumor.

Primary Outcome Measure

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) [ Time Frame: Up to 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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