Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT01864759|
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced or Metastatic Melanoma||Biological: ICOVIR-5||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma|
|Actual Study Start Date :||January 11, 2013|
|Actual Primary Completion Date :||December 20, 2016|
|Actual Study Completion Date :||April 26, 2017|
ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.
- Maximum tolerated dose [ Time Frame: 4 weeks ]The highest dose where less than two out of three or six patients suffered dose limiting toxicity.
- Recommended dose [ Time Frame: 4 weeks ]
- Anti-tumour activity [ Time Frame: 4 weeks ]
- Viral pharmacokinetics [ Time Frame: 1 day ]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 ]Virus presence in tumors at day 5 post-administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864759
|Institut Català d'Oncologia - L'Hospitalet|
|L'Hospitalet del Llobregat, Barcelona, Spain, 08908|
|Principal Investigator:||Ramon Salazar, MD PhD||Institut Català d'Oncologia|
|Study Chair:||Ramon Alemany, PhD||Institut Català d'Oncologia|