Predictive Value of Circulating Melanoma Cells (CMCs) in Metastatic Melanoma (MM) Patients Treated With Selective Inhibitors of BRAF

Istituto Oncologico Veneto IRCCS1 site in 1 country200 target enrollmentDecember 2011

ConditionsMetastatic Melanoma

InterventionsAnti-B-RAF

DrugsAnti-B-RAF

Overview

Phase: Not Applicable
Intervention: Anti-B-RAF
Conditions: Metastatic Melanoma
Sponsor: Istituto Oncologico Veneto IRCCS
Enrollment: 200
Locations: 1
Primary Endpoint: Change of CMC count during treatment and comparison with CT and PET
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study, is to evaluate Circulating Melanoma Cell (CMC) changes in Metastatic Melanoma (MM) patients, undergoing treatment with selective inhibitors of mutated BRAF.

Detailed Description

This is an observational prospective pilot study aimed to investigate the association between changes of total and apoptotic CMC count and disease progression in MM patients undergoing treatment with selective inhibitors of mutated B-RAF.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

December 2017

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Istituto Oncologico Veneto IRCCS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Fourth stage Melanoma patients with both measurable and not measurable lesions undergoing treatment with selective B-RAF inhibitors will be included. To determine the prevalence of CMC-positive patients in IV stage Melanoma, patients without mutated B-RAF undergoing chemotherapy and/or vaccines will be also enrolled at baseline, as part of study protocols approved and activated in the participating centers.
•Informed written consent.

Exclusion Criteria

•Inadequate compliance to multiple blood draws (baseline, 15 days, 1th month, 4th month, and/or at progression) as scheduled in this adjunctive biologic study for patients carrying B-FAF mutation; inadequate compliance to adjunctive blood draws, as scheduled at baseline for BRAF wild-type
•Previously exposure to immunological treatment.