Dabrafenib Mesylate for Glioma

1
Effectiveness
2
Safety
Tampa General Hospital, Tampa, FL
Glioma+10 More
Dabrafenib Mesylate - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Glioma

Study Summary

This study is evaluating whether a combination of two drugs may help treat children and young adults with high grade glioma.

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Eligible Conditions

  • Glioma
  • Glioblastoma
  • Ganglioglioma
  • Astrocytoma
  • Anaplastic Astrocytoma, Not Otherwise Specified
  • WHO Grade 3 Glioma
  • Pleomorphic Xanthoastrocytoma, Anaplastic
  • Gliomas, Malignant
  • Anaplastic Astrocytoma (AA)
  • WHO Grade III Glioma
  • Anaplastic Ganglioglioma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Dabrafenib Mesylate will improve 1 primary outcome and 3 secondary outcomes in patients with Glioma. Measurement will happen over the course of From the date of diagnosis until disease progression date, secondary malignant neoplasm occurrence date, death date of any cause, or last follow-up, assessed up to 5 years.

Year 5
Event-free survival (EFS) for stratum 2 and stratum 3
Year 5
Overall survival (OS) for stratum 1, stratum 2, and stratum 3
Year 5
Event-free survival (EFS) for stratum 1
Up to 5 years
Incidence of adverse events

Trial Safety

Trial Design

2 Treatment Groups

Control
Treatment (radiation therapy, dabrafenib, trametinib)

This trial requires 58 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dabrafenib Mesylate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (radiation therapy, dabrafenib, trametinib)Patients undergo standardized local RT 5 days a week (Monday-Friday) for 6-7 weeks. Four weeks after completion of RT, patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methane
Not yet FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080
Trametinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Tampa General Hospital - Tampa, FL

Eligibility Criteria

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 10 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Specimens obtained at the time of diagnostic biopsy or surgery must be submitted through APEC14B1 as soon as possible (ASAP), preferably within 5 calendar days of the procedure. show original
The submission of this document is for the purpose of review and comment only. show original
PRE-ENROLLMENT ELIGIBILITY SCREENING (STEP 0): Patients must be >= 12 months and =< 21 years of age at the time of enrollment on Step 0
Note: This age range encompasses pre-screening for all HGG patients. Individual treatment protocols may have different age criteria
PRE-ENROLLMENT ELIGIBILITY SCREENING (STEP 0): Patient and/or their parents or legal guardians have signed informed consent for eligibility screening on APEC14B1 Part A.
Patients must be >= 3 years and =< 21 years of age at the time of enrollment
You are eligible for this criterion if you have been confirmed as having APEC14B1. show original
Newly diagnosed high-grade glioma with BRAF^V600-mutation
Results for H3 K27M by immunohistochemistry (IHC) or sequencing. show original
Patient is suspected of having localized newly-diagnosed HGG, excluding metastatic disease. show original

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 the signs of glioma?

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Signs of brain cancer are diverse and depend on the specific tumor type. Most symptoms are nonspecific. Specific signs may be helpful in a specific subtype of tumor with a particular clinical presentation.

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

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In 2011, 3,966 newly diagnosed male and female glioma patients were reported in the US. Of this number, an estimated 2,200 patients were aged ≥50 years. It is worth noting that glioma is typically associated with a late onset of age, which increases the number of patients with this diagnosis in the older population.

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Can glioma be cured?

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The majority of gliomas are curable: only 2-4% of gliomas inevitably fail surgical treatment. However, the time interval between surgery and radiation therapy and dose-volume calculations need to be optimized.

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What are common treatments for glioma?

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The mainstay of treatment for newly diagnosed gliomas is surgery followed by chemotherapy and radiotherapy. More recently, targeted therapies targeting the growth of the tumor with specific antibodies and anti-angiogenic agents are being tested.

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What causes glioma?

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The epidemiology of glioma is closely associated with the type of occupational exposure. In our study we found an increased risk of glioma only in subjects exposed to welding fumes when compared to other main welding exposures. In our study, we observed a significant risk only in subjects exposed to welding fumes when compared to non-welders and a similar increased risk when compared to non-welder workers who were exposed to cement dust. We speculate that these exposures have a synergistic effect on glioma. Based on our results, we believe it is useful to assess the cumulative exposure to welding and cement dust in future studies. We propose that welders and cement workers should be followed up for a long period of time.

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What is glioma?

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The histogenesis of glioma is incompletely elucidated but is believed to be due to different types of neoplastic astrocytes. Glioma is a common neurologic tumor that produces a wide range of symptoms, from subtle to devastating, depending on the location and the malignant histological type of the tumor.

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What are the common side effects of dabrafenib mesylate?

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The side effect profile of dabrafenib was generally consistent with the known pharmacology of BRAF-targeted therapy and comparable to previous published reports of clinical trials on the same drug. Common adverse events include mild to moderate nausea (25%), fatigue (18%), insomnia (17%), dizziness (17%), and headache (6%). In order to prevent or diminish severity of these side effects dabrafenib is administered with a high fat-content diet. However, some of these side effects may be avoided if patients are more closely monitored for the first 4 weeks of treatment. For example, no dose adjustment or other changes are necessary if the first two doses are given.

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Have there been other clinical trials involving dabrafenib mesylate?

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We have not found any additional clinical trials of DA to have been completed. Although dabrafenib is a very promising agent, there is no definitive data yet on dabrafenib's toxicity profile, which is currently being tested in Phase III clinical trials. We are thus eager to see whether other clinical trials to test the clinical activity of this agent will soon begin in our facility, and, if so, the drug's anticipated toxicity profile--in comparison to the chemotherapeutic agent temozolomide--will be established.

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What is the average age someone gets glioma?

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In recent studies, the average age of onset (male = 44.2 years; female = 38.6 years) seems to have almost halved in North America, compared to Denmark, where it remained unchanged. This finding is not explicable by differences in socioeconomic status.

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Is dabrafenib mesylate typically used in combination with any other treatments?

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For this single-agent phase II Dabrafenib monotherapy study, it is notable that dabrefenib was well tolerated in terms of severity and frequency of serious events, and the most common adverse events observed were fatigue and increased fatigue. It is also noteworthy that the combination of dabrafenib with vorinostat demonstrated better response rates compared to monotherapy, and dabrafenib was considered to be a promising new anticancer drug for advanced gliomas in refractory cases.

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How serious can glioma be?

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The prognosis of glioma is not always good: many patients do not survive 5 years and hardly any get long-term cure from glioma and this makes them much more serious and demanding. The long-term survival is not a random event: for the sake of curing the tumor, it is important to get in early diagnosis and treatment.

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What are the latest developments in dabrafenib mesylate for therapeutic use?

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The current results show that treatment of patient-derived xenografts with a pharmacologically active and selectively toxic formulation of a targeted kinase inhibitor demonstrates promising results.

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