Circulating Melanoma Cells in Metastatic Patients Treated With Selective BRAF Inhibitors

Metastatic Melanoma Clinical Trial

— CMCBRAF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01878396
• Other study ID #: IOV2011/35
• Secondary ID: CE IOV 2011/35
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2013
• Last updated: September 30, 2016
• Start date: December 2011
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Istituto Oncologico Veneto IRCCS
• Contact: Vanna Chiarion-Sileni, MD
• Phone: 0039 0498215931
• Email: mgaliz[@]tiscali.it
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of HealthItaly: National Institute of HealthItaly: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• Anti-B-RAF

Locations

Country	Name	City	State
Italy	Vanna Chiarion-Sileni, MD	Padova	PD

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS	Janssen Diagnostics, LLC

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Mocellin S, Del Fiore P, Guarnieri L, Scalerta R, Foletto M, Chiarion V, Pilati P, Nitti D, Lise M, Rossi CR. Molecular detection of circulating tumor cells is an independent prognostic factor in patients with high-risk cutaneous melanoma. Int J Cancer. 2004 Sep 20;111(5):741-5. — View Citation

Mocellin S, Hoon D, Ambrosi A, Nitti D, Rossi CR. The prognostic value of circulating tumor cells in patients with melanoma: a systematic review and meta-analysis. Clin Cancer Res. 2006 Aug 1;12(15):4605-13. — View Citation

Rao C, Bui T, Connelly M, Doyle G, Karydis I, Middleton MR, Clack G, Malone M, Coumans FA, Terstappen LW. Circulating melanoma cells and survival in metastatic melanoma. Int J Oncol. 2011 Mar;38(3):755-60. doi: 10.3892/ijo.2011.896. Epub 2011 Jan 3. — View Citation

Rossi E, Basso U, Celadin R, Zilio F, Pucciarelli S, Aieta M, Barile C, Sava T, Bonciarelli G, Tumolo S, Ghiotto C, Magro C, Jirillo A, Indraccolo S, Amadori A, Zamarchi R. M30 neoepitope expression in epithelial cancer: quantification of apoptosis in circulating tumor cells by CellSearch analysis. Clin Cancer Res. 2010 Nov 1;16(21):5233-43. doi: 10.1158/1078-0432.CCR-10-1449. Epub 2010 Oct 26. — View Citation

Rossi E, Fassan M, Aieta M, Zilio F, Celadin R, Borin M, Grassi A, Troiani L, Basso U, Barile C, Sava T, Lanza C, Miatello L, Jirillo A, Rugge M, Indraccolo S, Cristofanilli M, Amadori A, Zamarchi R. Dynamic changes of live/apoptotic circulating tumour cells as predictive marker of response to sunitinib in metastatic renal cancer. Br J Cancer. 2012 Oct 9;107(8):1286-94. doi: 10.1038/bjc.2012.388. Epub 2012 Sep 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of CMC count during treatment and comparison with CT and PET		24 months	No