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

Institut Català d'Oncologia

Status and phase

Completed

Phase 1

Conditions

Locally Advanced or Metastatic Melanoma

Treatments

Biological: ICOVIR-5

Study type

Interventional

Funder types

Other

Identifiers

NCT01864759

2008-005694-35 (EudraCT Number)

ICOVIR5-2

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.