Children, Metastases, Solid Tumors
Conditions
Keywords
Mesenchymal stem cells, Oncolytic adenovirus
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.
Interventions
BIOLOGICALCELYVIR
Sponsors
Instituto de Salud Carlos III
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed