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

Phase 1

Completed

• Conditions: Solid Tumors; Children; Metastases
• Interventions: Biological: CELYVIR

• Registration Number: NCT01844661
• Lead Sponsor: Hospital Infantil Universitario Niño Jesús, Madrid, Spain

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-01
• Primary Completion: 2014-12
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CELYVIR	CELYVIR	Patients will received weekly (n=6) IV infusion of Celyvir.

Primary Outcome Measures

Name	Time	Method
Adverse effects after intravenous infusions	48 hours after each infusion	We will record any sign or symptom that could be related to the infusion of Celyvir.

Secondary Outcome Measures

Name	Time	Method
Clinical outcome	Up to 2 months after the last infusion	Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression.

Trial Locations

Locations (1)

Hospital Universitario Niño Jesús; 🇪🇸 Madrid, Spain