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

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ClinicalTrials.gov Identifier: NCT01844661
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : February 19, 2016
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Manuel Ramírez, MD PhD, Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Children Solid Tumors Metastases Biological: CELYVIR Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2016

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   6 Months to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844661


Locations
Spain
Hospital Universitario Niño Jesús
Madrid, Spain, 28009
Sponsors and Collaborators
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Instituto de Salud Carlos III
Investigators
Principal Investigator: Manuel Ramírez, MD PhD Hospital Universitario Niño Jesús

Responsible Party: Manuel Ramírez, MD PhD, Dr., Hospital Infantil Universitario Niño Jesús, Madrid, Spain
ClinicalTrials.gov Identifier: NCT01844661     History of Changes
Other Study ID Numbers: EudraCT2008-000364-16
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Manuel Ramírez, MD PhD, Hospital Infantil Universitario Niño Jesús, Madrid, Spain:
Mesenchymal stem cells
Oncolytic adenovirus