Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma

Melanoma Clinical Trial

Official title:

Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573494
• Other study ID #: 11-AOI-04
• Status: Completed
• Phase: N/A
• First received: March 23, 2012
• Last updated: June 25, 2014
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. The detection of CTC by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown encouraging results. The investigators propose a prospective study of the CellSearch system in patients with melanoma.

Primary objective: To determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma.

Secondary objectives:

• determine the percentage of patients with metastatic melanoma with melanoma cells circulating

• seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma

• seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients > or = 18 years

• Patients with advanced melanoma stage IIIC (unresectable) or stage IV

• Patient not treated or not responding to chemotherapy with chemotherapy session last> 1 month

• Patients who signed informed consent

• Patients presenting no socio-economic, psychological, familial or geographical allow proper understanding of the information leaflet of the protocol or the regular monitoring in the department of dermatology

• Patients with a life expectancy greater than 3 months

• Patients with melanoma measurable by RECIST version 1.1

• Patients with venous good for venipuncture

Exclusion Criteria:

• Patients with contraindication for treatment with chemotherapy or V600E BRAF inhibitor or ipilimumab or have conditions concomitant heavy may interfere with the treatment of metastatic melanoma

• Pregnant women or nursing

• People vulnerable detainees, adults under guardianship or curatorship, minors.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Melanoma
• Neoplastic Cells, Circulating

Intervention

Other:
• Sampling of blood
7,5 ml of blood

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the number of circulating melanoma cells/ml in blood	Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.	baseline and 3 months	No
Secondary	number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test	Calculating the number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test before and after treatment.	3 months	No
Secondary	Difference in survival	Difference in survival between patients depending on the number of circulating melanoma cells/ml before treatment, according to Kaplan-Meier method.	baseline and 6 months	No
Secondary	Difference in tumor response	Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.	6 months	No