Trial Information
Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Adverse effects after intravenous infusions
Outcome Description:
We will record any sign or symptom that could be related to the infusion of Celyvir.
Outcome Time Frame:
48 hours after each infusion
Safety Issue:
Yes
Principal Investigator
Manuel Ramírez, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital Universitario Niño Jesús
Authority:
Spain: Spanish Agency for Medicine and Health Products
Study ID:
EudraCT2008-000364-16
NCT ID:
NCT01844661
Start Date:
January 2013
Completion Date:
March 2015
Related Keywords:
- Children
- Solid Tumors
- Metastases
- Mesenchymal stem cells
- Oncolytic adenovirus
- Neoplasm Metastasis