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

August 28, 2017 updated by: Institut Català d'Oncologia

Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet del Llobregat, Barcelona, Spain, 08908
        • Institut Català d'Oncologia - L'Hospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICOVIR5
ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.
Biological: ICOVIR-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose
Time Frame: 4 weeks
The highest dose where less than two out of three or six patients suffered dose limiting toxicity.
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Recommended dose
Time Frame: 4 weeks
4 weeks
Anti-tumour activity
Time Frame: 4 weeks
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral pharmacokinetics
Time Frame: 1 day
Viremia at 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours after endovenous injection.
1 day
Viral pharmacodynamics
Time Frame: 5 days
Virus presence in tumors at day 5 post-administration.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Català d'Oncologia

Investigators

  • Principal Investigator: Ramon Salazar, MD PhD, Institut Catala d'Oncologia
  • Study Chair: Ramon Alemany, PhD, Institut Catala d'Oncologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2013

Primary Completion (Actual)

December 20, 2016

Study Completion (Actual)

April 26, 2017

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 29, 2013

First Posted (Estimate)

May 30, 2013

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICOVIR5-2
  • 2008-005694-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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