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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 1, 2013
Last Update Posted Date February 19, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2013)
Clinial 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
Official Title  ICMJE Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Children
  • Solid Tumors
  • Metastases
Intervention  ICMJE Biological: CELYVIR
Other Name: Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus.
Study Arms  ICMJE Experimental: CELYVIR
Patients will received weekly (n=6) IV infusion of Celyvir.
Intervention: Biological: CELYVIR
Publications * Ruano D, López-Martín JA, Moreno L, Lassaletta Á, Bautista F, Andión M, Hernández C, González-Murillo Á, Melen G, Alemany R, Madero L, García-Castro J, Ramírez M. First-in-Human, First-in-Child Trial of Autologous MSCs Carrying the Oncolytic Virus Icovir-5 in Patients with Advanced Tumors. Mol Ther. 2020 Apr 8;28(4):1033-1042. doi: 10.1016/j.ymthe.2020.01.019. Epub 2020 Jan 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01844661
Other Study ID Numbers  ICMJE EudraCT2008-000364-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manuel Ramírez, MD PhD, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Study Sponsor  ICMJE Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborators  ICMJE Instituto de Salud Carlos III
Investigators  ICMJE
Principal Investigator: Manuel Ramírez, MD PhD Hospital Universitario Niño Jesús
PRS Account Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP