Overview

Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults

Status:
Completed
Trial end date:
2019-05-27
Target enrollment:
0
Participant gender:
All
Summary
Phase I/II, open, prospective clinical trial, historically controlled. The objective is to evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Criteria
Inclusion Criteria:

- Signed informed consent

- Diagnosis or metastatic or relapsed sarcoma or high grade central nervous system tumor

- From 3 to 40 years

- Surgery feasibility. In the central nervous system tumors, residual tumor after
surgery must be minimal.

Exclusion Criteria:

- Toxicity or liver, medullar, renal insufficiency that advise against participation

- Pregnant or breast feeding women

- Diagnosis of other tumor than basal cell squamous carcinoma of the skin or in situ
cervix carcinoma

- Immunosuppressive treatment

- Human Immunodeficiency virus (HIV), hepatitis B, hepatitis C or syphilis infection