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A Pilot Study to evaluate the pharmacokinetic, pharmacodynamic, and resistance profile to trametinib and dabrafenib in BRAF-V600E mutated recurrent gliomas
This research is being done to understand how much of two drugs (dabrafenib and trametinib) is able to enter brain tumors and how well the drugs are able to turn off this pathway in brain tumors. The study will also look at how tumors lose sensitivity to this treatment. People with primary brain tumors who are already taking dabrafenib and trametinib and who need a brain surgery are eligible for this study. Biospecimens (tissue, blood, and cerebrospinal fluid (CSF)) taken during the surgery will help us understand how much of these two study drugs actually get into the brain, their effect, and how the tumors become resistant to treatment.
18 year(s) or older
Inclusion Criteria:At least 18 years old
Subjects must have a history of primary brain tumor (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), anaplastic ganglioglioma (AG), and anaplastic pleomorphic xanthoastrocytoma (PXA)).
Subjects must have a BRAF-V600 mutation identified in previous tissue analysis (may be IHC or PCR based). Allowable mutations include V600E, V600K, V600R, and V600D.
Subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7 days prior to surgery as prescribed by their treating physician.
Subjects must be undergoing surgery for clinical purposes
Exclusion Criteria:Younger than 18 year old
Subjects who are receiving any other investigational agents or chemotherapeutic agents.
3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response using Ex vivo Interrogation of Live Cells from Tumors
Patients are being asked to participate in this study because they may have one of the following: Brain Cancer (high-grade gliomas (HGG) that are limited to Glioblastoma Multiforme (GBM) or Anaplastic Astrocytoma (AA)). This study will collect data for a registry that records how a patient's cancer tissue responds to different types of approved chemotherapy drugs. The results of the responses will be shared with the patient's physician. The purpose of this study is to measure the accuracy of new investigational laboratory tests which could predict which chemotherapies are most active to each individual patient’s tumor. KIYATEC has validated a test, the Ex-Vivo 3-Dimensional Drug Response Assay (EV3D, the Assay) prior to use in this study. In this study, KIYATEC will establish the clinical correlation and utility of the Assay in various cancer subtypes.
18 year(s) or older
Inclusion Criteria:Age 18 years and older
Diagnosis of or suspected diagnosis of glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA)
Patient must undergo elective surgery or biopsy to remove tumor tissue
Consideration as a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy
Exclusion Criteria:Age of <18 years
Do not have a diagnosis of or suspected diagnosis of glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA)
Patient will not have surgery or a biopsy as part of routine clinical practice
Patient has known active cancer metastatic to the brain except for patients with brain metastases that have been treated and are considered stable
Patient refuses to have the assay performed on their tissue