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

NCT01844661 | Completed Phase 1

• 1 other identifier: EudraCT2008-000364-16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Children; Solid Tumors; Metastases

Keywords

Mesenchymal stem cells; Oncolytic adenovirus

Outcome Measures

Primary Outcomes (1)

• Adverse effects after intravenous infusions

  We will record any sign or symptom that could be related to the infusion of Celyvir.

  48 hours after each infusion

Secondary Outcomes (1)

• Clinical outcome

  Up to 2 months after the last infusion

Study Arms (1)

CELYVIR

EXPERIMENTAL

Patients will received weekly (n=6) IV infusion of Celyvir.

Biological: CELYVIR

Interventions

CELYVIR BIOLOGICAL

Also known as: Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus.

CELYVIR

Eligibility Criteria

• Age: 6 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy.
• Central Nervous System metastasis.
• Experimental therapy during the previous month.
• Chemotherapy less than 3 weeks previous.
• Any organ functionally impaired.
• Concurrent infectious disease.

Sponsors & Collaborators

• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitario Niño Jesús

Madrid, Madrid, 28009, Spain

Location

Related Publications (2)

• 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.

  PMID: 33737338 DERIVED

• 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.

  PMID: 32053771 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Ramírez, MD PhD

  Hospital Universitario Niño Jesús

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2016
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

ES (1)