Status:
COMPLETED
Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma
Lead Sponsor:
Institut Català d'Oncologia
Conditions:
Locally Advanced or Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 oncoly...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01864759
Start Date
January 11 2013
End Date
April 26 2017
Last Update
August 29 2017
Active Locations (1)
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1
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona, Spain, 08908