Melanoma
Conditions
Brief 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.
Interventions
DRUGEndothelin Receptor B inhibitor BQ788
DRUGPBS
Sponsors
California Institute of Technology
University of Bern
Universitaire Ziekenhuizen KU Leuven
MelCure SA
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumour response by size measurement and histological examination | 3 to14 days |
Secondary
| Measure | Time frame |
|---|---|
| Measuring changes in tumor cell proliferation by histological analyses using Ab staining | 3 to 14 days |
| Evaluation of changes in mRNA as well as protein expression levels of Endothelin Receptor B by PCR and Ab staining | 3 to 14 days |
| Evaluation of changes in blood vessels formation by histological examination using Ab staining | 3 to 14 days |
| Evaluation of changes in immune cell infiltration by histological examination using Ab staining | 3 to 14 days |
Outcome results
None listed