Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma
The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally replicative or oncolytic adenovirus.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma|
- Maximum tolerated dose [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]The highest dose where less than two out of three or six patients suffered dose limiting toxicity.
- Recommended dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Anti-tumour activity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Viral pharmacokinetics [ Time Frame: 1 day ] [ Designated as safety issue: No ]Viremia at 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours after endovenous injection.
- Viral pharmacodynamics [ Time Frame: 5 days ] [ Designated as safety issue: No ]Virus presence in tumors at day 5 post-administration.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01864759
|Contact: Ramon Salazar, MD PhDemail@example.com|
|Contact: Marta Gil, MDfirstname.lastname@example.org|
|Institut Català d'Oncologia - L'Hospitalet||Recruiting|
|L'Hospitalet del Llobregat, Barcelona, Spain, 08908|
|Principal Investigator: Ramón Salazar, MD PhD|
|Sub-Investigator: Marta Gil, MD|
|Sub-Investigator: Maria Ochoa de Olza, MD|
|Principal Investigator:||Ramon Salazar, MD PhD||Institut Catala D'Oncologia|
|Study Chair:||Ramon Alemany, PhD||Institut Català d'Oncologia|