Circulating Melanoma Cells in Metastatic Patients Treated With Selective BRAF Inhibitors

• Conditions: Metastatic Melanoma
• Interventions: Drug: Anti-B-RAF

• Registration Number: NCT01878396
• Lead Sponsor: Istituto Oncologico Veneto IRCCS

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-17
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-03
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mutated Anti-B-RAF	Anti-B-RAF	Fourth stage Melanoma patients with both measurable and not measurable lesions undergoing treatment with selective B-RAF inhibitors.

Primary Outcome Measures

Name	Time	Method
Change of CMC count during treatment and comparison with CT and PET	24 months

Trial Locations

Locations (1)

Vanna Chiarion-Sileni, MD; 🇮🇹 Padova, PD, Italy