Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
NCT ID: NCT01844661
Last Updated: 2016-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2013-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CELYVIR
Patients will received weekly (n=6) IV infusion of Celyvir.
CELYVIR
Interventions
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CELYVIR
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adults: 18-75 yrs. Refractory to at least 2 previous therapy lines. ECOG (Eastern Cooperative Oncology Group) \<2. Measurable disease.
Exclusion Criteria
* Central Nervous System metastasis.
* Experimental therapy during the previous month.
* Chemotherapy less than 3 weeks previous.
* Any organ functionally impaired.
* Concurrent infectious disease.
6 Months
75 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
OTHER
Responsible Party
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Manuel Ramírez, MD PhD
Dr.
Principal Investigators
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Manuel Ramírez, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Niño Jesús
Locations
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Hospital Universitario Niño Jesús
Madrid, Madrid, Spain
Countries
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References
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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.
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.
Other Identifiers
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EudraCT2008-000364-16
Identifier Type: -
Identifier Source: org_study_id
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