Trial | NCT01844661  Report issue

Title

Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    celyvir ...

  • Study Participants

    20
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 Started
Jan 31
2013
Primary Completion
Dec 31
2014
Study Completion
Jan 31
2016
Last Update
Feb 19
2016
Estimate

Biological CELYVIR

  • Other names: Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus.

CELYVIR Experimental

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

Criteria 

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.
No Results Posted