NCT02496520

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 3 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase I/II, open, prospective clinical trial, historically controlled. Patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors will be included. The patients will receive standard treatment and experimental treatment based on a cellular therapy with vaccination with autologous dendritic cells pulsed with tumor lysate. The immunization schedule includes 4 monthly vaccines, 4 bimonthly and quarterly remaining vaccines. The vaccines will be administered intradermally in combination with standard treatment for each type of tumor.

Conditions

• Sarcoma
• Central Nervous System Tumor

Interventions

Type	Name	Description
BIOLOGICAL	dendritic cells	vaccines with dendritic cells pulsed with tumor lysate
PROCEDURE	Surgery as needed by the patient´s tumor and stage
DRUG	Chemotherapy as needed by the patient´s tumor and stage
RADIATION	Radiation therapy as needed by the patient´s tumor and stage

Timeline

• Start date: 2014-09-30
• Primary completion: 2018-09-16
• Completion: 2019-05-27
• First posted: 2015-07-14
• Last updated: 2020-02-21

Locations

1 site across 1 country: Spain