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

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastases; Children; Solid Tumors

Treatments: Biological: CELYVIR

Study type: Interventional

Funder types: Other

Identifiers

NCT01844661

EudraCT2008-000364-16

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 6 months to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CELYVIR

Experimental group

Description:

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

Treatment:

Biological: CELYVIR