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

February 19, 2020 updated by: Clinica Universidad de Navarra, Universidad de Navarra
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • University Clinic of Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and type of adverse events detected in the follow up as a measure of safety and tolerability
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
36 months
Humoral and cellular immune response as a measure of the immunogenicity of the vaccine.
Time Frame: 2 weeks to 24 months
2 weeks to 24 months
Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires.
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Principal Investigator: Ana Patiño-García, PhD, CUN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2014

Primary Completion (Actual)

September 16, 2018

Study Completion (Actual)

May 27, 2019

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEND/TIA
  • 2013-003632-71 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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