Back to resultsSafety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
Primary Purpose
Children, Solid Tumors, Metastases
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
CELYVIR
Sponsored by
About this trial
This is an interventional treatment trial for Children focused on measuring Mesenchymal stem cells, Oncolytic adenovirus
Eligibility 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.
Sites / Locations
- Hospital Universitario Niño Jesús
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CELYVIR
Arm Description
Patients will received weekly (n=6) IV infusion of Celyvir.
Outcomes
Primary Outcome Measures
Adverse effects after intravenous infusions
We will record any sign or symptom that could be related to the infusion of Celyvir.
Secondary Outcome Measures
Clinical outcome
Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression.
Full Information
NCT ID
NCT01844661
First Posted
April 29, 2013
Last Updated
February 18, 2016
Sponsor
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT01844661
Brief Title
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
Official Title
Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborators
Instituto de Salud Carlos III
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Solid Tumors, Metastases
Keywords
Mesenchymal stem cells, Oncolytic adenovirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CELYVIR
Arm Type
Experimental
Arm Description
Patients will received weekly (n=6) IV infusion of Celyvir.
Intervention Type
Biological
Intervention Name(s)
CELYVIR
Other Intervention Name(s)
Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus.
Primary Outcome Measure Information:
Title
Adverse effects after intravenous infusions
Description
We will record any sign or symptom that could be related to the infusion of Celyvir.
Time Frame
48 hours after each infusion
Secondary Outcome Measure Information:
Title
Clinical outcome
Description
Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression.
Time Frame
Up to 2 months after the last infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Ramírez, MD PhD
Organizational Affiliation
Hospital Universitario Niño Jesús
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Niño Jesús
City
Madrid
ZIP/Postal Code
28009
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33737338
Citation
Morales-Molina A, Gambera S, Leo A, Garcia-Castro J. Combination immunotherapy using G-CSF and oncolytic virotherapy reduces tumor growth in osteosarcoma. J Immunother Cancer. 2021 Mar;9(3):e001703. doi: 10.1136/jitc-2020-001703.
Results Reference
derived
PubMed Identifier
32053771
Citation
Ruano D, Lopez-Martin JA, Moreno L, Lassaletta A, Bautista F, Andion M, Hernandez C, Gonzalez-Murillo A, Melen G, Alemany R, Madero L, Garcia-Castro J, Ramirez 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.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
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