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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Català d'Oncologia
ClinicalTrials.gov Identifier:
NCT01864759
First received: May 22, 2013
Last updated: August 28, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Locally Advanced or Metastatic Melanoma Biological: ICOVIR-5 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Institut Català d'Oncologia:

Primary Outcome Measures:
  • 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:
  • Recommended dose [ Time Frame: 4 weeks ]
  • Anti-tumour activity [ Time Frame: 4 weeks ]

Other Outcome Measures:
  • 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.

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


Enrollment: 14
Actual Study Start Date: January 11, 2013
Study Completion Date: April 26, 2017
Primary Completion Date: December 20, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICOVIR5
ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.
Biological: ICOVIR-5

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: May 22, 2013
Last Updated: August 28, 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

ClinicalTrials.gov processed this record on September 21, 2017