Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.

February 18, 2016 updated by: Manuel Ramírez, MD PhD, Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.

The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. In addition to data on toxicities the investigators will evaluate clinical response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28009
        • Hospital Universitario Niño Jesús

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 73 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children: Up to 18 yrs. Refractory to at least 2 previous therapy lines. Life expectancy more than 6 months. Measurable disease.
  • Adults: 18-75 yrs. Refractory to at least 2 previous therapy lines. ECOG (Eastern Cooperative Oncology Group) <2. Measurable disease.

Exclusion Criteria:

  • Pregnancy.
  • Central Nervous System metastasis.
  • Experimental therapy during the previous month.
  • Chemotherapy less than 3 weeks previous.
  • Any organ functionally impaired.
  • Concurrent infectious disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CELYVIR
Patients will received weekly (n=6) IV infusion of Celyvir.
Biological: CELYVIR
Other Names:
  • Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects after intravenous infusions
Time Frame: 48 hours after each infusion
We will record any sign or symptom that could be related to the infusion of Celyvir.
48 hours after each infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome
Time Frame: Up to 2 months after the last infusion
Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression.
Up to 2 months after the last infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Manuel Ramírez, MD PhD, Hospital Universitario Niño Jesús

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT2008-000364-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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