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OpenTrials
Completed

NCT Number: NCT01844661

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

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Key information

Conditions

Children Metastases Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Solid Tumors

Age range

6 month–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Universitario Niño Jesús

Madrid, 28009, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

CELYVIR

Biological

Other names: Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
May 1, 2013
Registry last updated
Feb 19, 2016

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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