Clinical trial · Interventional
Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma
Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma
NCT01864759CI-TRIAL-00029312completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICOVIR-5 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICOVIR5
- description
- ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.
- interventionNames
- Biological: ICOVIR-5
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- 4 weeks
- description
- The highest dose where less than two out of three or six patients suffered dose limiting toxicity.
Secondary outcomes (2)
- measure
- Recommended dose
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Malignant melanoma advanced or metastatic. * Other than 18 years * Karnofsky index \> 60 % * Life expectancy \> 3 months * ALT/AST \<=2.5 times the upper normal limit * Creatinine clearance \>= 50 ml/min. * Bilirubin \<25 umol/l * Alkaline phosphatase \<= 2.5 time upper normal limit * Normal bone marrow function: Neutrophils \>=1.5 E9/L, platelets \>= 1E11/L, hemoglobin \>= 100 g/l, Normal prothrombin time and thromboplastin time, * HIV negative * Measurable disease * Signed informed consent. Exclusion Criteria: * Geographical, social or psychological conditions that may impair the protocol compliance. * Active infections or other severe medical status. * History of liver disease. * Other or concomitant treatments for melanoma or investigational product. * Previous participation in studies with adenovirus. * Virus diseases diagnosed two weeks before inclusion. * Immunosuppressive concomitant treatments * Concomitant malignant haematological disease. * Patients having family members with immunodeficient status or disease * Patients with Li Fraumeni syndrome or germinal retinoblastoma gene defects.
References
Publications (1)
- BACKGROUNDCascallo 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. PMID 17579575