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

University of Navarra

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sarcoma; Central Nervous System Tumor

Treatments: Radiation: Radiation therapy as needed by the patient´s tumor and stage; Drug: Chemotherapy as needed by the patient´s tumor and stage; Biological: dendritic cells; Procedure: Surgery as needed by the patient´s tumor and stage

Study type: Interventional

Funder types: Other

Identifiers

NCT02496520

2013-003632-71 (EudraCT Number)

DEND/TIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 3 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Vaccines with autologous dendritic cells

Experimental group

Description:

Vaccines with autologous dendritic cells

Treatment:

Radiation: Radiation therapy as needed by the patient´s tumor and stage

Procedure: Surgery as needed by the patient´s tumor and stage

Drug: Chemotherapy as needed by the patient´s tumor and stage

Biological: dendritic cells