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

Phase 1

Completed

• Conditions: Locally Advanced or Metastatic Melanoma
• Interventions: Biological: ICOVIR-5

• Registration Number: NCT01864759
• Lead Sponsor: Institut Català d'Oncologia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-29
• Study First Posted: 2013-05-30
• Primary Completion: 2016-12-20
• Study Completion: 2017-04-26
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICOVIR5	ICOVIR-5	ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	4 weeks	The highest dose where less than two out of three or six patients suffered dose limiting toxicity.

Secondary Outcome Measures

Name	Time	Method
Recommended dose	4 weeks
Anti-tumour activity	4 weeks

Trial Locations

Locations (1)

Institut Català d'Oncologia - L'Hospitalet; 🇪🇸 L'Hospitalet del Llobregat, Barcelona, Spain