Trametinib for Brain Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Chicago Comprehensive Cancer Center, Chicago, IL
Brain Cancer+2 More
Trametinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether trametinib with whole brain radiation therapy is better than trametinib alone for treating patients with brain metastases.

See full description

Eligible Conditions

  • Brain Cancer
  • Metastatic Malignant Neoplasm in the Brain

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Trametinib will improve 2 primary outcomes, 6 secondary outcomes, and 1 other outcome in patients with Brain Cancer. Measurement will happen over the course of Up to 4 weeks.

Year 2
Overall survival
Year 2
Neurologic progression-free survival
Up to 2 years
Local control rate
Up to 3 years
Objective response rate per Response Evaluation Criteria in Solid Tumors
Up to 4 weeks
Proportion of patients who complete treatment per protocol
Up to 8 weeks
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)
Overall tolerability and toxicity of the regimen, as assessed by adverse events and their grade and attribution for each dose level, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse (CTCAE) version 5.0
Up to day 14
Quantification of cyclin D1, p27, pERK-1/2, pAKT, PTEN, pMTOR, pS6K, and pS6 of resected metastatic brain lesions via immunohistochemistry
Up to day 28
Quantification of trametinib in resected brain metastatic lesions utilizing high performance liquid chromatography/tandem mass spectrometry (Cohort B)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Cohort A (trametinib, whole-brain radiation therapy)
1 of 2
Cohort B (trametinib, surgery)
1 of 2
Experimental Treatment

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Trametinib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

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.
Cohort B (trametinib, surgery)Patients receive trametinib PO QD on days 1-14 followed by surgical resection of the tumor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
FDA approved
Therapeutic Conventional Surgery
2014
Completed Phase 3
~8360
Whole-Brain Radiotherapy
2012
Completed Phase 2
~150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Closest Location

University of Chicago Comprehensive Cancer Center - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
Eastern Cooperative Oncology Group (ECOG) performance status 0 -1
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
Absolute neutrophil count >= 1.5 x 10^9/L
Hemoglobin >= 9 g/dL
Platelets >= 100 x10^9/L
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulation
Albumin >= 2.5 g/dL
Total bilirubin =< 1.5 x ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN

Patient Q&A Section

What causes brain cancer?

"The cause of brain cancer remains uncertain. It is likely that environmental factors, such as cigarette smoking, are the cause of around half of brain tumours. Inherited predispositions and some diseases like leukemia also increase the risk. The exact cause of only a small number of cases is not known, and the exact cause of a few of these cases has not been determined. While it is important to explore possible environmental causes of brain tumour, it is unlikely that a single environmental factor will be discovered to cause many or all brain tumours." - Anonymous Online Contributor

Unverified Answer

Can brain cancer be cured?

"Despite advances in diagnostics and therapy, the cure is not always achievable. The disease, however, can be controlled with effective treatment, which can prolong live and improve quality of life." - Anonymous Online Contributor

Unverified Answer

What are the signs of brain cancer?

"Brain tumours can produce a range of symptoms. The effects of brain tumours on behaviour can be very severe or very subtle. Symptoms that can precede and follow tumour-related changes can alter or lessen some of the symptoms of a tumour. Many of the symptoms of brain tumour are similar to the symptoms of other neurological conditions, such as stroke, so can mimic a stroke. The symptoms that indicate brain tumour include headache, vision problems, difficulty talking (dysphasia) or other weakness (e.g." - Anonymous Online Contributor

Unverified Answer

How many people get brain cancer a year in the United States?

"Brain cancer is rare in US. There is a need for improved awareness of brain cancer, as many patients are unaware of the disease and do not realise their likelihood of being a brain cancer patient. More research is needed to understand why the burden of fatal brain tumours is higher in some of the western countries, which have higher rates of lung cancer, and why there is no association with the rate of breast cancer." - Anonymous Online Contributor

Unverified Answer

What is brain cancer?

"Brain or nervous system cancer typically has either a typical or atypical manifestation, with symptoms usually including headaches, focal neurological deficits, nausea and vomiting, or loss of appetite. The most common types of brain or nervous system tumors in adults are high-grade glioma and malignant astrocytoma. Other types of brain tumors include neurocytoma and primitive neuroectodermal tumors, as well as meningiomas and pituitary tumors." - Anonymous Online Contributor

Unverified Answer

What are common treatments for brain cancer?

"The treatment options for [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer)s are very broad and varied. Most treatments are aimed at reducing the load of symptoms from the tumor, while preserving cerebral function. This is usually achieved by reducing tumor burden and increasing blood pressures and flow. The exact type of surgery may depend on the location and function of the tumor in relation to critical brain structures, including the hypothalamus, and can be either elective or emergency, depending on the location and size of the malignant mass. Adjuvant therapy with radiation is often given for tumors with minimal tumor burden, or for lower-grade tumors with high risk of local relapse." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of brain cancer?

"Results from a recent clinical trial is limited to patients who underwent surgical resection. Additional histopathologic analysis will assess the presence of residual tumor, infiltration of blood vessels by tumor cells, and vascular and perineural invasion by tumor cells." - Anonymous Online Contributor

Unverified Answer

How quickly does brain cancer spread?

"The time taken for metastasis to develop and the degree of metastatic metastatic disease burden were highly variable. The number of metastatic disease sites and the timing of metastasis development also varied widely. Patients with brain metastases from breast cancer had a relatively short interval until development of metastatic disease." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating brain cancer?

"The recent developments regarding new treatment approaches for patients with [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) can be broadly classified into four types of cancer. One is an alteration in the cell metabolism, resulting in a high glycolysis, that is often seen in glioma. The other is the overexpression in cancer cells of one of the major cancer oncogenes, that is often seen, and has been shown in several brain tumors, of the K-Ras oncogene. Another pathway of cancer development, that is frequently affected by brain tumors, is the alteration of the p53 tumor suppressor gene, which stops the DNA repair system, causing accumulation of damaged genes and finally leading to uncontrolled cell proliferation." - Anonymous Online Contributor

Unverified Answer

What is the latest research for brain cancer?

"(1) Findings from a recent study highlights the limitations, especially in terms of a thorough understanding of all clinical factors leading to the development of brain tumors. All patients need to be carefully monitored and tested for tumors which may be as small as a single cell in spite of a lack of imaging and other methods that may allow the detection of single tumor cells. (2) Brain tumor researchers will need to examine more patients and develop and validate more accurate and comprehensive tumor grading schemes for future clinical trials. This research will help to better understand the complexities involved with the diagnosis and the management of patients diagnosed with malignant brain cancer. Moreover, the clinical data to be recorded for validation will include epidemiological features." - Anonymous Online Contributor

Unverified Answer

Does trametinib improve quality of life for those with brain cancer?

"Because the symptoms of advanced/treated brain cancer can have a debilitating impact on the patient's psychological well-being, the treatment effects on HRQoL should be a major consideration in clinical trials of targeted therapies aimed to suppress the progression of secondary brain tumors." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing brain cancer?

"The age group of 10-40 years is where almost all childhood cancers start. From then on the higher the risk of getting brain cancer. What it is worthwhile to remember is that brain cancer can occur in anybody of any age. But if you want to keep your brain healthy, keep your body healthy. Eating your fruits and vegetables and eating well balanced meals every day, drinking plenty of water and get regular exercise like every other health-promoting thing-it will not only keep your body healthy but can also reduce your chances (although no guarantee) of getting cancer in the future." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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