Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma

Melanoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02442466
• Other study ID #: MelCure
• Status: Terminated
• Phase: Phase 0
• First received: April 26, 2015
• Last updated: May 18, 2015
• Start date: May 2011

Study information

• Verified date: May 2015
• Source: MelCure SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Internal Review Board Inselspital
• Study type: Interventional

Clinical Trial Summary

Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and relevance of results observed in pre-clinical studies to the human disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written Informed consent

• Histologically confirmed melanoma

• Disease stage III or IV

• At least 2 injectable and surgically removable cutaneous metastasis

• Age > 18 years

• Clinically stable medical condition

Exclusion Criteria:

• Primary ocular melanoma

• Symptomatic intracranial melanoma

• History of severe neurological, cardiovascular, renal, hepatic, endocrinological, respiratory, bone marrow, autoimmune or infectious (HIV) disease

• Pregnancy or lactation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Endothelin Receptor B inhibitor BQ788

• PBS

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
MelCure SA	California Institute of Technology, Universitaire Ziekenhuizen Leuven, University of Bern

References & Publications (5)

Lahav R, Dupin E, Lecoin L, Glavieux C, Champeval D, Ziller C, Le Douarin NM. Endothelin 3 selectively promotes survival and proliferation of neural crest-derived glial and melanocytic precursors in vitro. Proc Natl Acad Sci U S A. 1998 Nov 24;95(24):14214-9. — View Citation

Lahav R, Heffner G, Patterson PH. An endothelin receptor B antagonist inhibits growth and induces cell death in human melanoma cells in vitro and in vivo. Proc Natl Acad Sci U S A. 1999 Sep 28;96(20):11496-500. — View Citation

Lahav R, Suvà ML, Rimoldi D, Patterson PH, Stamenkovic I. Endothelin receptor B inhibition triggers apoptosis and enhances angiogenesis in melanomas. Cancer Res. 2004 Dec 15;64(24):8945-53. — View Citation

Lahav R, Ziller C, Dupin E, Le Douarin NM. Endothelin 3 promotes neural crest cell proliferation and mediates a vast increase in melanocyte number in culture. Proc Natl Acad Sci U S A. 1996 Apr 30;93(9):3892-7. — View Citation

Lahav R. Endothelin receptor B is required for the expansion of melanocyte precursors and malignant melanoma. Int J Dev Biol. 2005;49(2-3):173-80. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour response by size measurement and histological examination		3 to14 days	No
Secondary	Measuring changes in tumor cell proliferation by histological analyses using Ab staining		3 to 14 days	No
Secondary	Evaluation of changes in mRNA as well as protein expression levels of Endothelin Receptor B by PCR and Ab staining		3 to 14 days	No
Secondary	Evaluation of changes in blood vessels formation by histological examination using Ab staining		3 to 14 days	No
Secondary	Evaluation of changes in immune cell infiltration by histological examination using Ab staining		3 to 14 days	No