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

Clinica Universidad de Navarra, Universidad de Navarra6 enrolled

Overview

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 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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoma Central Nervous System Tumor

Interventions

dendritic cellsBIOLOGICAL

vaccines with dendritic cells pulsed with tumor lysate

Surgery as needed by the patient´s tumor and stagePROCEDURE

Chemotherapy as needed by the patient´s tumor and stageDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

University Clinic of Navarra

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

Event free progression, overall survival, time to progression and number and size of existent tumoral lesions as measures of clinical efficacy

Time frame: 36 months

Humoral and cellular immune response as a measure of the immunogenicity of the vaccine.

Time frame: 2 weeks to 24 months

Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires.

Time frame: 36 months

Data from ClinicalTrials.gov

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