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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Institut Català d'Oncologia
Sponsor:
Information provided by (Responsible Party):
Institut Català d'Oncologia
ClinicalTrials.gov Identifier:
NCT01864759
First received: May 22, 2013
Last updated: January 14, 2014
Last verified: January 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Anti-tumour activity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Viral pharmacokinetics [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Virus presence in tumors at day 5 post-administration.


Estimated Enrollment: 15
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Ramon Salazar, MD PhD 34.93.260.77.44 ramonsalazar@iconcologia.net
Contact: Marta Gil, MD 34.93.260.77.44 mgilmartin@iconcologia.net

Locations
Spain
Institut Català d'Oncologia - L'Hospitalet Recruiting
L'Hospitalet del Llobregat, Barcelona, Spain, 08908
Principal Investigator: Ramón Salazar, MD PhD         
Sub-Investigator: Marta Gil, MD         
Sub-Investigator: Maria Ochoa de Olza, MD         
Sponsors and Collaborators
Institut Català d'Oncologia
Investigators
Principal Investigator: Ramon Salazar, MD PhD Institut Catala 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
Study First Received: May 22, 2013
Last Updated: January 14, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

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

ClinicalTrials.gov processed this record on July 31, 2014