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NCT01844661 Clinical Trial

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

Solid Tumors Clinical Trial

Official title:
Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01844661
Other study ID # EudraCT2008-000364-16
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received April 29, 2013
Last updated February 18, 2016
Start date January 2013
Est. completion date January 2016

Study information
Verified date February 2016
Source Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency for Medicine and Health Products
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 2016
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 75 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• CELYVIR

Locations
Country Name City State
Spain Hospital Universitario Niño Jesús Madrid

Sponsors (2)
Lead Sponsor Collaborator
Hospital Infantil Universitario Niño Jesús, Madrid, Spain Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Clinical outcome Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression. Up to 2 months after the last infusion No
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