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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005694-35 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICOVIR5 | Experimental | ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICOVIR-5 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | The highest dose where less than two out of three or six patients suffered dose limiting toxicity. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended dose | 4 weeks | |
| Anti-tumour activity | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Viral pharmacokinetics | Viremia at 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours after endovenous injection. | 1 day |
| Viral pharmacodynamics | Virus presence in tumors at day 5 post-administration. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramon Salazar, MD PhD | Institut Català d'Oncologia | Principal Investigator |
| Ramon Alemany, PhD | Institut Català d'Oncologia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Català d'Oncologia - L'Hospitalet | L'Hospitalet Del Llobregat | Barcelona | 08908 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17579575 | Background | Cascallo M, Alonso MM, Rojas JJ, Perez-Gimenez A, Fueyo J, Alemany R. Systemic toxicity-efficacy profile of ICOVIR-5, a potent and selective oncolytic adenovirus based on the pRB pathway. Mol Ther. 2007 Sep;15(9):1607-15. doi: 10.1038/sj.mt.6300239. Epub 2007 Jun 19. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D000257 | Adenoviridae Infections |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 5 days |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |