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OpenTrials
Completed

NCT Number: NCT01864759

Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With 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.

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Key information

Conditions

Locally Advanced or Metastatic Melanoma Adenoviridae Infections DNA Virus Infections Infections Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, Barcelona, 08908, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICOVIR-5

Biological

Primary outcomes

  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 outcomes

  1. Recommended dose

    Time frame: 4 weeks

  2. Anti-tumour activity

    Time frame: 4 weeks

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Institut Català d'Oncologia

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
May 30, 2013
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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