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Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.


Phase 1/Phase 2
6 Months
75 Years
Open (Enrolling)
Both
Children, Solid Tumors, Metastases

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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

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