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

NCT ID: NCT01864759

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-11
• Study Completion Date: 2017-04-26

Brief 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.

Conditions

Locally Advanced or Metastatic Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICOVIR5

ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.

Group Type: EXPERIMENTAL

ICOVIR-5

Intervention Type: BIOLOGICAL

Interventions

ICOVIR-5

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Català d'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramon Salazar, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Català d'Oncologia

Ramon Alemany, PhD

Role: STUDY_CHAIR

Institut Català d'Oncologia

Locations

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 17579575 (View on PubMed)

Other Identifiers

2008-005694-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ICOVIR5-2

Identifier Type: -

Identifier Source: org_study_id