Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma

Locally Advanced or Metastatic Melanoma Clinical Trial

Official title:

Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864759
• Other study ID #: ICOVIR5-2
• Secondary ID: 2008-005694-35
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2013
• Last updated: August 28, 2017
• Start date: January 11, 2013
• Est. completion date: April 26, 2017

Study information

• Verified date: August 2017
• Source: Institut Català d'Oncologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 26, 2017
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoviridae Infections
• Locally Advanced or Metastatic Melanoma
• Melanoma

Intervention

Biological:
• ICOVIR-5

Locations

Country	Name	City	State
Spain	Institut Català d'Oncologia - L'Hospitalet	L'Hospitalet del Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Català d'Oncologia

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. Epub 2007 Jun 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Viral pharmacokinetics	Viremia at 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours after endovenous injection.	1 day
Other	Viral pharmacodynamics	Virus presence in tumors at day 5 post-administration.	5 days
Primary	Maximum tolerated dose	The highest dose where less than two out of three or six patients suffered dose limiting toxicity.	4 weeks
Secondary	Recommended dose		4 weeks
Secondary	Anti-tumour activity		4 weeks