NCT01864759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

3.9 years

First QC Date

May 22, 2013

Last Update Submit

August 28, 2017

Conditions

Locally Advanced or Metastatic Melanoma

Keywords

melanomaoncolyticadenovirusvirotherapylocally advancedmetastatic

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    The highest dose where less than two out of three or six patients suffered dose limiting toxicity.

    4 weeks

Secondary Outcomes (2)

  • Recommended dose

    4 weeks

  • Anti-tumour activity

    4 weeks

Other Outcomes (2)

  • Viral pharmacokinetics

    1 day

  • Viral pharmacodynamics

    5 days

Study Arms (1)

ICOVIR5

EXPERIMENTAL

ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.

Biological: ICOVIR-5

Interventions

ICOVIR-5BIOLOGICAL
ICOVIR5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, Barcelona, 08908, Spain

Location

Related Publications (1)

  • Cascallo M, Alonso MM, Rojas JJ, Perez-Gimenez A, Fueyo J, Alemany R. Systemic toxicity-efficacy profile of ICOVIR-5, a potent and selective oncolytic adenovirus based on the pRB pathway. Mol Ther. 2007 Sep;15(9):1607-15. doi: 10.1038/sj.mt.6300239. Epub 2007 Jun 19.

    PMID: 17579575BACKGROUND

MeSH Terms

Conditions

MelanomaAdenoviridae InfectionsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesDNA Virus InfectionsVirus DiseasesInfectionsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ramon Salazar, MD PhD

    Institut Català d'Oncologia

    PRINCIPAL INVESTIGATOR

  • Ramon Alemany, PhD

    Institut Català d'Oncologia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2013

First Posted

May 30, 2013

Study Start

January 11, 2013

Primary Completion

December 20, 2016

Study Completion

April 26, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

ES(1)