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

NCT ID: NCT02496520

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-05-27

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.

Conditions

Sarcoma; Central Nervous System Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaccines with autologous dendritic cells

Vaccines with autologous dendritic cells

Group Type: EXPERIMENTAL

dendritic cells

Intervention Type: BIOLOGICAL

vaccines with dendritic cells pulsed with tumor lysate

Surgery as needed by the patient´s tumor and stage

Intervention Type: PROCEDURE

Chemotherapy as needed by the patient´s tumor and stage

Intervention Type: DRUG

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

Intervention Type: RADIATION

Interventions

dendritic cells

vaccines with dendritic cells pulsed with tumor lysate

Intervention Type: BIOLOGICAL

Surgery as needed by the patient´s tumor and stage

Intervention Type: PROCEDURE

Chemotherapy as needed by the patient´s tumor and stage

Intervention Type: DRUG

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Patiño-García, PhD

Role: PRINCIPAL_INVESTIGATOR

CUN

Locations

University Clinic of Navarra

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

2013-003632-71

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DEND/TIA

Identifier Type: -

Identifier Source: org_study_id