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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.