Retrospective Evaluation of Melanocortin Receptor 4 Polymorphisms in Patients With GBM Treated With Radiochemotherapy

NCT02458508 | Completed DMC

• 1 other identifier: University of Pisa
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Glioblastoma (GBM) accounts for approximately 50% of all glioma and among these tumors, are the most malignant. The cells of origin of glioma are still undefined, but the most putative target cells include astrocytes, neural stem cells, and oligodendrocyte precursor cells. The current standard of care for patients with newly diagnosed GBM includes temozolomide and radiotherapy . Melanocortins are peptides with well-recognized anti-inflammatory and neuroprotective activity. Of the five known melanocortin receptors (MCRs), only subtype 4 is present in astrocytes and it is expressed predominantly in the brain. No data are currently available on MC4R gene polymorphisms and gliomas or their relationship with radiotherapy or chemotherapy. Aim. Given the association of MC4R with antiinflammatory activity, neuroprotection, induction of neural stem/progenitor cell proliferation in brain hypoxia, and prevention of astrocyte apoptosis, the aim of this study is to retrospectively evaluate the possible prognostic/predictive role of the MC4R SNPs on GBM therapy.

Conditions

Glioblastoma

Keywords

MC4R; chemotherapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  progression-free survival in GBM patients with different MC4R genotypes and treated with combined radiotherapy and temozolomide

  12 months

Secondary Outcomes (1)

• overall survival

  24 months

Study Arms (1)

GBM patients

patients with diagnosis of glioblastoma treated with concomitant radio-chemotherapy with temozolomide as Stupp protocol will be evaluated for pharmacogenetic evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of glioblastoma treated with concomitant radio-chemotherapy with temozolomide as Stupp protocol will be evaluated for pharmacogenetic evaluation.

You may qualify if:

• Patients with proven diagnosis of GBM
• Patients suitable for Radio-chemotherapy with temozolomide
• Eastern Cooperative Oncology Group Performance Status 0-2
• Age ≥ 18 years
• Willingness to provide a blood sample for genetic analysis

You may not qualify if:

• Patients previously treated with radio or chemotherapy for central nervous system cancer

Sponsors & Collaborators

• University of Pisa: lead
• Azienda Ospedaliero, Universitaria Pisana: collaborator

Study Sites (1)

Division of Radiotherapy, Department Of Oncology, University Hospital of Pisa

Pisa, 56126, Italy

Location

Related Publications (4)

• Caruso C, Carniglia L, Durand D, Scimonelli TN, Lasaga M. Astrocytes: new targets of melanocortin 4 receptor actions. J Mol Endocrinol. 2013 Sep 11;51(2):R33-50. doi: 10.1530/JME-13-0064. Print 2013 Oct.

  PMID: 23881919 RESULT

• Giuliani D, Minutoli L, Ottani A, Spaccapelo L, Bitto A, Galantucci M, Altavilla D, Squadrito F, Guarini S. Melanocortins as potential therapeutic agents in severe hypoxic conditions. Front Neuroendocrinol. 2012 Apr;33(2):179-93. doi: 10.1016/j.yfrne.2012.04.001. Epub 2012 Apr 17.

  PMID: 22531139 RESULT

• Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.

  PMID: 19269895 RESULT

• Preusser M, de Ribaupierre S, Wohrer A, Erridge SC, Hegi M, Weller M, Stupp R. Current concepts and management of glioblastoma. Ann Neurol. 2011 Jul;70(1):9-21. doi: 10.1002/ana.22425.

  PMID: 21786296 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (3 ml) will be collected in EDTA tubes and stored at -80°C from glioblastoma patients

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Guido Bocci, MD, PhD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asssistant Professor; MD, PhD

Study Record Dates

• First Submitted: May 23, 2015
• First Posted: June 1, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

IT (1)