Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK (SVALMEL)
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|ClinicalTrials.gov Identifier: NCT03553329|
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
The therapeutic arsenal of metastatic melanoma has changed considerably over the past 10 years. The treatment of metastatic melanoma is now based on immunotherapy and targeted therapies, while the place of conventional chemotherapy becomes more restricted. Targeted therapies are indicated for BRAF mutated melanomas.
The mutation BRAF leads activation of MAP Kinases pathway and the proliferation of melanoma cell in the body . About 50% of metastatic melanoma is BRAF mutated. The most frequent mutation is the V600E. The targeted therapy by anti BRAF and anti MEK allows the double bloking of the MAP Kinases pathway. This treatment is more efficient than that of the anti BRAF alone. The association of anti BRAF and anti MEK have a global survival global rate of 41% at the 1 year, against 9% for the anti BRAF .
In 2014, a program of extended access to the association of anti BRAF and anti MEK (dabrafenib and trametinib) started in many french hospitals (Protocol Mekinist, Novartis laboratory). Patients who were included in this program and followed in Poitiers Hospital, had frequent abnormalities of albumin level without any sign of undernutrition.
Hypoabuminemia is a poor prognosis factor described in many cancers, including metastatic melanoma.
The only prognostic factor in metastatic melanoma is the rate of LDH . The level of albumin and its prognostic impact have not been studied for patients with a metastatic melanoma and treated by anti BRAF and anti MEK.
The objective of this studie was to analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated in our Center by dabrafenib and trametinib
|Condition or disease||Intervention/treatment|
|Unresecable Stage IIIc or IV Melanoma||Drug: dabrafenib|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK|
|Actual Study Start Date :||June 2, 2018|
|Actual Primary Completion Date :||June 2, 2018|
|Actual Study Completion Date :||June 2, 2018|
- Drug: dabrafenib
Monthly biological assessment which included: blood count, a blood electrolytes, an creatininemia, a dosage of urea, a dosage of transaminases, of gammaGT, of phosphatases alkaline, of LDH and of albumin.Other Name: trametinib
- Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib [ Time Frame: 1 months ]Biological assessment
- Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib [ Time Frame: 3 months ]Biological assessment
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553329
|CHU DE Poitiers|
|Poitiers, France, 86021|