Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Locally Advanced or Metastatic Melanoma
Both
Locally Advanced or Metastatic Melanoma
Trial Information
Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Outcome Description:
The highest dose where less than two out of three or six patients suffered dose limiting toxicity.
Outcome Time Frame:
4 weeks
Safety Issue:
Yes
Principal Investigator
Ramon Salazar, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Catala D'Oncologia
Authority:
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study ID:
ICOVIR5-2
NCT ID:
NCT01864759
Start Date:
January 2013
Completion Date:
June 2015
Related Keywords:
- Locally Advanced or Metastatic Melanoma
- melanoma
- oncolytic
- adenovirus
- virotherapy
- locally advanced
- metastatic
- Adenoviridae Infections
- Melanoma
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