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

Hospital Infantil Universitario Niño Jesús, Madrid, Spain20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Children Solid Tumors Metastases

Interventions

CELYVIRBIOLOGICAL

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Niño Jesús

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

Adverse effects after intravenous infusions

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

Time frame: 48 hours after each infusion

Secondary Outcomes

Clinical outcome

Clinical outcome will be labelled as complete response, partial response, stable disease or disease progression.

Time frame: Up to 2 months after the last infusion

Data from ClinicalTrials.gov

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