DEND/TIA: Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra (Other)

Overall Status

Completed

CT.gov ID

NCT02496520

Collaborator

(none)

Enrollment

Location

Arm

55.9

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma Central Nervous System Tumor	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	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 30, 2014

Actual Primary Completion Date :

Sep 16, 2018

Actual Study Completion Date :

May 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaccines with autologous dendritic cells Vaccines with autologous dendritic cells	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

Arm

Intervention/Treatment

Experimental: Vaccines with autologous dendritic cells

Vaccines with autologous dendritic cells

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

Outcome Measures

Primary Outcome Measures

Number and type of adverse events detected in the follow up as a measure of safety and tolerability [24 months]

Secondary Outcome Measures

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]
Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires. [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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