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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01573494
First received: March 23, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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

Condition Intervention
Melanoma
Other: Sampling of blood

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Measuring the number of circulating melanoma cells/ml in blood [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.


Secondary Outcome Measures:
  • number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Difference in survival [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Difference in survival between patients depending on the number of circulating melanoma cells/ml before treatment, according to Kaplan-Meier method.

  • Difference in tumor response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.


Enrollment: 30
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metastatic melanoma patients
Sampling of blood before and after chemotherapy
Other: Sampling of blood
7,5 ml of blood

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573494

Locations
France
CHU de Nice
Nice, France, 06202
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Study Director: Damien GIACCHERO, PH CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01573494     History of Changes
Other Study ID Numbers: 11-AOI-04
Study First Received: March 23, 2012
Last Updated: June 25, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nice:
Cancer
Melanoma
Circulating Tumor Cells

Additional relevant MeSH terms:
Melanoma
Neoplastic Cells, Circulating
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014