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

Primary Purpose

Locally Advanced or Metastatic Melanoma

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
ICOVIR-5
Sponsored by
Institut Català d'Oncologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced or Metastatic Melanoma focused on measuring melanoma, oncolytic, adenovirus, virotherapy, locally advanced, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institut Català d'Oncologia - L'Hospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICOVIR5

Arm Description

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

Outcomes

Primary Outcome Measures

Maximum tolerated dose
The highest dose where less than two out of three or six patients suffered dose limiting toxicity.

Secondary Outcome Measures

Recommended dose
Anti-tumour activity

Full Information

First Posted
May 22, 2013
Last Updated
August 28, 2017
Sponsor
Institut Català d'Oncologia
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1. Study Identification

Unique Protocol Identification Number
NCT01864759
Brief Title
Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma
Official Title
Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 11, 2013 (Actual)
Primary Completion Date
December 20, 2016 (Actual)
Study Completion Date
April 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Català d'Oncologia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Melanoma
Keywords
melanoma, oncolytic, adenovirus, virotherapy, locally advanced, metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICOVIR5
Arm Type
Experimental
Arm Description
ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.
Intervention Type
Biological
Intervention Name(s)
ICOVIR-5
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Description
The highest dose where less than two out of three or six patients suffered dose limiting toxicity.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Recommended dose
Time Frame
4 weeks
Title
Anti-tumour activity
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Viral pharmacokinetics
Description
Viremia at 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours after endovenous injection.
Time Frame
1 day
Title
Viral pharmacodynamics
Description
Virus presence in tumors at day 5 post-administration.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramon Salazar, MD PhD
Organizational Affiliation
Institut Català d'Oncologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramon Alemany, PhD
Organizational Affiliation
Institut Català d'Oncologia
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Català d'Oncologia - L'Hospitalet
City
L'Hospitalet del Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
17579575
Citation
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.
Results Reference
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Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma

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