Status:
COMPLETED
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
Lead Sponsor:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Children
Solid Tumors
Eligibility:
All Genders
6-75 years
Phase:
PHASE1
PHASE2
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 m...
Eligibility Criteria
Inclusion
- 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
- Pregnancy.
- Central Nervous System metastasis.
- Experimental therapy during the previous month.
- Chemotherapy less than 3 weeks previous.
- Any organ functionally impaired.
- Concurrent infectious disease.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01844661
Start Date
January 1 2013
End Date
January 1 2016
Last Update
February 19 2016
Active Locations (1)
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1
Hospital Universitario Niño Jesús
Madrid, Madrid, Spain, 28009