CLINICAL TRIAL

Mirdametinib for Glioma

Newly Diagnosed
Recurrent
Stage I
Recruiting · < 65 · All Sexes · Memphis, TN

This study is evaluating whether a drug called mirdametinib can help treat a type of brain tumor called low-grade glioma.

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About the trial for Glioma

Eligible Conditions
Recurrent Low-grade Gliomas · Glioma · Progressive Low-Grade Gliomas · Low Grade Glioma (LGG)

Treatment Groups

This trial involves 5 different treatments. Mirdametinib is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Mirdametinib
DRUG
Experimental Group 2
Mirdametinib
DRUG
Experimental Group 3
Mirdametinib
DRUG
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Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Glioma or one of the other 3 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Inclusion Criteria: Screening Phase
Participants with histologically confirmed or suspected low-grade glioma, including neuronal and mixed neuronal-glial tumors
Participant must have adequate tumor tissue from primary and/or relapsed tumor for central pathology review
Projected to be ≥ 2 years and < 25 years at the time of study enrollment
Phase 1: Dose Finding/Dose-escalation
For Phase 1 participant's BSA must fall within the range specified in the protocol for the specific dose level under evaluation.
For Phase 2 of the study the upper BSA restrictions will be removed.
Participant and/or guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 month after start of mirdametinib treatment
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month after start of mirdametinib treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 month after start of mirdametinib treatment.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Mirdametinib will improve 8 primary outcomes and 14 secondary outcomes in patients with Glioma. Measurement will happen over the course of Course 1: Days 1 and 15.

Characterize the maximum plasma concentration and area under the concentration-time curve (AUC0-8h) of mirdametinib.
COURSE 1: DAYS 1 AND 15
Mirdametinib plasma concentration will be provided and area under the curve (AUC0-8h) estimated based on course 1, days 1 and 15 PK samples
COURSE 1: DAYS 1 AND 15
Phase 2, Cohort 3b: Estimate 6-month disease stabilization rate
UP TO 6 MONTHS (SLIGHT DEPARTURES FROM THIS TIMING ALLOWED BASED ON MRI SCREENING) AFTER START OF MIRDAMETINIB TREATMENT
Rate of stable disease from start of treatment until the time of progression or time of last follow-up.
UP TO 6 MONTHS (SLIGHT DEPARTURES FROM THIS TIMING ALLOWED BASED ON MRI SCREENING) AFTER START OF MIRDAMETINIB TREATMENT
Phase 2, Cohort 3a: Estimate 1-year disease stabilization rate
UP TO 12 MONTHS (SLIGHT DEPARTURES FROM THIS TIMING ALLOWED BASED ON MRI SCREENING) AFTER START OF MIRDAMENTINIB TREATMENT
Rate of stable disease from start of treatment until the time of progression or time of last follow-up.
UP TO 12 MONTHS (SLIGHT DEPARTURES FROM THIS TIMING ALLOWED BASED ON MRI SCREENING) AFTER START OF MIRDAMENTINIB TREATMENT
Longitudinal change in adaptive behavior, by cohort
BASELINE (AT ENROLLMENT), 9 MONTHS, 2 YEARS, AND 5 YEARS AFTER START OF MIRDAMETINIB TREATMENT
To evaluate the effects of mirdametinib treatment on adaptive behavior in children treated for low-grade glioma. This will be assessed using the Adaptive Behavior Assessment System, Third Edition (ABAS-3, ages 2-21.11), which rates the child's ability to independently perform age-appropriate daily living skills. Scores will be summarized by timepoint and cohort using descriptive statistics and appropriate plots.
BASELINE (AT ENROLLMENT), 9 MONTHS, 2 YEARS, AND 5 YEARS AFTER START OF MIRDAMETINIB TREATMENT
Longitudinal change in memory, by cohort
9 MONTHS, 2 YEARS, AND 5 YEARS AFTER START OF MIRDAMETINIB TREATMENT
To evaluate the effects of mirdametinib treatment on memory in children treated for low-grade glioma. This will be assessed using different instruments as age appropriate: California Verbal Learning Test, Children's Version (CVLT-C) will be used to measure verbal list learning in children 6-16.11 years of age; the NEPSY-II Memory for Designs subtest (ages 6-16.11) and Wechsler Memory Scale (WMS-IV, ages 17 and older ) will assess nonverbal memory; the Children's Memory Scale (CMS, ages 5-16.11) and WMS-IV (ages 17 and older) Story Memory subtests will assess immediate recall, delayed recall, and recognition of details. Scores for each measure will be summarized by timepoint and cohort using descriptive statistics and appropriate plots.
9 MONTHS, 2 YEARS, AND 5 YEARS AFTER START OF MIRDAMETINIB TREATMENT
Rates of Progressive Disease (PD), by cohort
UP TO 5 YEARS AFTER THE LAST ENROLLED PATIENT STARTS TREATMENT
Progressive Disease is defined as any of the following: A greater than 25% increase in target lesion area relative to reference scan, the development of a new tumor lesion, substantial growth (>25%) of a measurable metastatic lesion, or worsening of clinical and/or functional assessment directly related to tumor progression. Responses will be measured for each cohort from the date of initial treatment to the earliest date of progressive disease, or data of last follow-up.
UP TO 5 YEARS AFTER THE LAST ENROLLED PATIENT STARTS TREATMENT
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Patient Q & A Section

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

What are common treatments for glioma?

A number of commonly used treatments for glioma are available, varying in efficacy and side effects. Overall survival after surgery tends to be comparable regardless of the nature of the infiltrating brain tissue. Patients with glioblastoma multiforme typically receive radiation therapy, while patients with anaplastic astrocytoma typically receive chemotherapy.

Anonymous Patient Answer

What causes glioma?

glioma has a genetic component, but may have no direct relation to the environment or lifestyle. On the other hand, occupational exposures can impact both glioma frequency and the severity of symptoms for a given individual. The role of diet or tobacco smoking requires further study. Finally, environmental factors that increase the burden of cancer among the populace also are likely to increase its burden among glioma patients.

Anonymous Patient Answer

What is glioma?

Gliomas are brain tumors composed of cells of epithelial origin. They are generally classified into low-grade and high-grade types, which differ in their pathogenesis, clinical course and treatments.

Anonymous Patient Answer

How many people get glioma a year in the United States?

At least 50,000 new cases of glioma are diagnosed each year in the United States. About 1 person dies of glioma in the United States every day.

Anonymous Patient Answer

What are the signs of glioma?

The signs and symptoms of primary brain cancer are a manifestation of the tumour and can be divided into direct signs (e.g., a change in pupil or visual field) and indirect effects (e.g., loss of cognitive function or behavioural changes).

Anonymous Patient Answer

Can glioma be cured?

Radiotherapy, chemotherapy and surgery can reduce the size of a glioma. However, the size of the tumor remains highly variable even after multimodality therapy; radiotherapy may reduce the size of the tumor in a subset of patients and allow for tumor shrinkage without surgical resection at follow-up.

Anonymous Patient Answer

What is the latest research for glioma?

Recently, the field of neuroscience and neuroscience research has become a major source of information about the biology and treatment of gliomas. A more complete picture of these tumors will be achieved once more new technologies such as gene therapy, gene therapy with antibody molecules, use of chemotherapeutics, radiotherapy and biological therapy have been fully investigated. It is also important to understand the processes that lead from the generation of some brain neoplasms to their malignant transformation. A major challenge will be to find the molecular elements that are responsible for the changes that occur in glial cells of the brain.

Anonymous Patient Answer

What is mirdametinib?

The FDA approved IDH1 and IDH2 mutation-positive glioma patient is a special case in which, the use of mitotic inhibitor (including mirdametinib), can result in the improvement in terms of progression-free survival and also quality of life by the cancer patients by decreasing tumor progression. Clin Cancer Res; 1-12. ©2013 AACR.

Anonymous Patient Answer

Have there been other clinical trials involving mirdametinib?

There have been a couple of small phase II trials on the action of mirdametinib. Some of which showed the possibility of an additional benefit for patients. Further studies in order to investigate this action would be advantageous. It would also increase the safety by analyzing the pharmacokinetic profile of mirdametinib.

Anonymous Patient Answer

Is mirdametinib safe for people?

Patients with HRAS mutant/KRAS wild-type tumors may have an improved survival rate when treated with mirdametinib; in this small trial, this was not supported from results of toxicity and toxicity-specific OS.

Anonymous Patient Answer

Does mirdametinib improve quality of life for those with glioma?

The safety and convenience of mirdametinib led to greater tolerability than gemcitabine in cancer patients with glioma. Mirdametinib was associated with significant improvements in QoL including QoL for patients with glioma. In a recent study, findings are significant both in terms of patient acceptance and for patient caregivers.

Anonymous Patient Answer

Is mirdametinib typically used in combination with any other treatments?

Recent findings of this study suggest that mirdametinib can be used as a single agent, but with other treatment options at the forefront that can significantly aid the patient's overall survival and quality of life.

Anonymous Patient Answer
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