Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Melanoma

Neoplasm Metastasis

Brain Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Channel Blockers

Trametinib

Dabrafenib

Gallopamil

Protein Kinase Inhibitors

Enzyme Inhibitors

Subjects will receive dabrafenib 150 milligram (mg) twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity.

Subjects will receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily until evidence of disease progression, death, or unacceptable toxicity

Dabrafenib will be provided as 50 mg and 75 mg capsules

Trametinib will be provided as 0.5 mg and 2.0 mg tablets

Novartis Pharmaceuticals

This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma that has metastasized to the brain. This study will evaluate the safety and efficacy of 4 cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain, symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without prior local (brain) therapy, and range of ECOG scores from 0-2.

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response.

The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response. No hypothesis testing completed for cohort A, B,C and D

Disease Control rate is defined as the percentage of subjects achieving a confirmed intracranial/extracranial/overall CR or PR or SD or Non-CR/Non-PD. This is based on investigator-assessed response. No hypothesis testing completed for cohort A, B,C and D

Extracranial Response Rate was defined as the percentage of participants with Complete response (CR) or Partial response (PR) at anytime. This is based on investigator-assessed response. No hypothesis testing completed for cohort A,B,C and D

the number of subjects with a confirmed overall Complete response (CR) or Partial response (PR) by investigator assessment using the Response evaluation criteria in solid tumors (RECIST 1.1 criteria). To determine the overall response, all target and non-target lesions will be assessed using modified RECIST 1.1 criteria.

Duration of intracranial, extracranial and overall response, are defined as the time from first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression. No hypothesis testing completed for cohort A,B,C and D

PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. No hypothesis testing completed for cohort A,B,C and D

Overall survival (OS) is defined as the time from the first dose until death due to any cause. No hypothesis testing completed for cohort A,B,C and D

Cohort A

Cohort B

Cohort C

Cohort D

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Study Director

All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population.

Intracranial Response (IR) Rate in Cohort A

All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population

Intracranial Response Rate of Cohorts B, C and D

Intracranial

Extra cranial

Overall rate

Disease Control for Intracranial, Extracranial and Overall Response for Each Cohort

Extracranial Response Rate (ER) for Each Cohort

Overall Response (OR) for Each Cohort

Duration of intracranial

Duration of extracranial

Duration of Overall Response

Duration of Intracranial, Extracranial and Overall Response for Each Cohort

Progression-free Survival (PFS) for Each Cohort Based on Investigator Assessment

Overall Survival (OS) for Each Cohort

Overall Study

Postoperative Complications

Complications:

* Moderate to severe intracerebral hemorrhage confirmed in a brain CT scan (Midline shift in brain imaging ≥ 3 mm),
* İntracranial hypertension requiring post op surgical drainage,
* Status epilepticus or seizures,
* The need for tracheal intubation or use of mechanical ventilation after surgery,
* Decrease in GKS,
* Unmanageable agitation that requires restriction or sedation,
* Need for respiratory failure and oxygen therapy,
* Unexpected serious motor deficit
* Died

No complications are seen within 30 days and the patient is healthy

Lactate, a byproduct of glycolysis, is an indicator of weak tissue perfusion and a useful biomarker with prognostic value in various diseases. Lactate value is calculated by blood gas.

lactate level

Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery.

Glasgow Outcome Scale

SEVTAP HEKİMOĞLU ŞAHİN, Professor

ONUR KÜÇÜK, Resident

The aim of this study is to determine the effects of the level of metabolites used in routine on mortality and morbidity in patients who will undergo intracranial surgery with craniotomy.

In this study, in patients who are planned to have an intracranial mass operation with craniotomy, their medical histories, demographic features, comorbidities, preoperative radiotherapy treatment, the parameters examined in the preoperative routine will be collected as a file scan (previous operations, GKS, laboratory values). The classification of patients according to the 2016 World Health Organization Central Classification of Nervous System Tumors (WHO-CNS classification) and whether it is glial or non glial will be recorded from the clinical file. Intraoperative; hemodynamic data of patients; heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products delivered, anesthetic and other medications, and blood gas samples will be written from the anesthesia document after the operation is finished. For the study, the application of the anesthesiologist for the patient will not be interfered. If postoperative patients are sent to the intensive care unit, their laboratory values and clinical observations (mortality, morbidity, neurological sequelae, imaging techniques, GOSE (Glasgow outcome skale)) will be recorded. In our study, mortality and morbidity will be evaluated 30 days postoperatively, and if the patient was sent to the service from the intensive care unit in this process, the values in the postoperative clinic (mortality, morbidity, neurological evaluation, imaging techniques, pathology results) will be recorded from the patient document. If the patient was discharged 30 days before, outpatient data will be recorded. The patients will be classified by evaluating the collected data (intraoperative hemodynamic data, blood transfusions, postoperative neurological sequel, postoperative complications and mortality).

In our study; the effects of lactate level on mortality and morbidity will be investigated in patients undergoing an intracranial mass operation with general anesthesia.

Evaluation of Lactate in Patients Undergoing Glial and Non Glial Mass Surgery With Craniotomy

Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery. Glasgow Outcome Scale is a five-point scale. 1 point is considered death and five points as good recovery. As the score increases, morbidity and mortality decrease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain	NCT02039947	Melanoma and Br...	Dabrafenib Trametinib	18 Years -	Novartis
Evaluation of Lactate in Patients Undergoing Glial and Non Glial Mass Surgery With Craniotomy	NCT04584827	Lactate Brain Tumor Post-Op Complic...	lactate level Glasgow Outcome...	18 Years -	Trakya University

Spots Global Cancer Trial Database for intracranial

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