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

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ClinicalTrials.gov Identifier: NCT01864759
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Melanoma Biological: ICOVIR-5 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma
Actual Study Start Date : January 11, 2013
Primary Completion Date : December 20, 2016
Study Completion Date : April 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: 4 weeks ]
    The highest dose where less than two out of three or six patients suffered dose limiting toxicity.


Secondary Outcome Measures :
  1. Recommended dose [ Time Frame: 4 weeks ]
  2. Anti-tumour activity [ Time Frame: 4 weeks ]

Other Outcome Measures:
  1. 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.

  2. Viral pharmacodynamics [ Time Frame: 5 days ]
    Virus presence in tumors at day 5 post-administration.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864759


Locations
Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet del Llobregat, Barcelona, Spain, 08908
Sponsors and Collaborators
Institut Català d'Oncologia
Investigators
Principal Investigator: Ramon Salazar, MD PhD Institut Català d'Oncologia
Study Chair: Ramon Alemany, PhD Institut Català d'Oncologia
More Information

Publications:
Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT01864759     History of Changes
Other Study ID Numbers: ICOVIR5-2
2008-005694-35 ( EudraCT Number )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Institut Català d'Oncologia:
melanoma
oncolytic
adenovirus
virotherapy
locally advanced
metastatic

Additional relevant MeSH terms:
Melanoma
Adenoviridae Infections
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
DNA Virus Infections
Virus Diseases