Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK

NCT03553329 | Completed

• 1 other identifier: SVALMEL
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Unresecable Stage IIIc or IV Melanoma

Outcome Measures

Primary Outcomes (2)

• Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib

  Biological assessment

  1 months

• Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib

  Biological assessment

  3 months

Interventions

dabrafenib DRUG

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.

Also known as: trametinib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable stage IIIc or stage IV melanoma, including the Mekinist research protocol

You may qualify if:

• Age \> 18 ans
• the patients with unresecable stage IIIc or IV melanoma with BRAF V600 E or K mutation,
• treated by dabrafenib and trametinib by the program of extended access (research protocol Mekinist)

You may not qualify if:

• Age \< 18 ans
• patients who had less than 3 months of treatment,
• patients for which the albumin level could not be carried out before starting treatment, and after the first month

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU DE Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Interventions

dabrafenib; trametinib

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: June 12, 2018
• Study Start: June 2, 2018
• Primary Completion: June 2, 2018
• Study Completion: June 2, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

FR (1)