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

Phase 1

Completed

• Conditions: Central Nervous System Tumor; Sarcoma
• Interventions: Biological: dendritic cells; 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

• Registration Number: NCT02496520
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief 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.

Study Timeline

• Study Start: 2014-09-30
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Primary Completion: 2018-09-16
• Status Verified: 2019-05
• Study Completion: 2019-05-27
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccines with autologous dendritic cells	dendritic cells	Vaccines with autologous dendritic cells
Vaccines with autologous dendritic cells	Radiation therapy as needed by the patient´s tumor and stage	Vaccines with autologous dendritic cells
Vaccines with autologous dendritic cells	Surgery as needed by the patient´s tumor and stage	Vaccines with autologous dendritic cells
Vaccines with autologous dendritic cells	Chemotherapy as needed by the patient´s tumor and stage	Vaccines with autologous dendritic cells

Primary Outcome Measures

Name	Time	Method
Number and type of adverse events detected in the follow up as a measure of safety and tolerability	24 months

Secondary Outcome Measures

Name	Time	Method
Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires.	36 months
Event free progression, overall survival, time to progression and number and size of existent tumoral lesions as measures of clinical efficacy	36 months
Humoral and cellular immune response as a measure of the immunogenicity of the vaccine.	2 weeks to 24 months

Trial Locations

Locations (1)

University Clinic of Navarra; 🇪🇸 Pamplona, Navarra, Spain