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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Children Solid Tumors Metastases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CELYVIR

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

Group Type EXPERIMENTAL

CELYVIR

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CELYVIR

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Manuel Ramírez, MD PhD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manuel Ramírez, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Niño Jesús

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario Niño Jesús

Madrid, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33737338 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32053771 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT2008-000364-16

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.