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

Primary Purpose

Sarcoma, Central Nervous System Tumor

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
dendritic cells
Surgery as needed by the patient´s tumor and stage
Chemotherapy as needed by the patient´s tumor and stage
Radiation therapy as needed by the patient´s tumor and stage
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring dendritic cell vaccination, sarcoma, central nervous system tumor, childhood, adolescent, immunotherapy

Eligibility Criteria

3 Years - 40 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • University Clinic of Navarra

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccines with autologous dendritic cells

Arm Description

Vaccines with autologous dendritic cells

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Event free progression, overall survival, time to progression and number and size of existent tumoral lesions as measures of clinical efficacy
Humoral and cellular immune response as a measure of the immunogenicity of the vaccine.
Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires.

Full Information

First Posted
June 15, 2015
Last Updated
February 19, 2020
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT02496520
Brief Title
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
Acronym
DEND/TIA
Official Title
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 30, 2014 (Actual)
Primary Completion Date
September 16, 2018 (Actual)
Study Completion Date
May 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Central Nervous System Tumor
Keywords
dendritic cell vaccination, sarcoma, central nervous system tumor, childhood, adolescent, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccines with autologous dendritic cells
Arm Type
Experimental
Arm Description
Vaccines with autologous dendritic cells
Intervention Type
Biological
Intervention Name(s)
dendritic cells
Intervention Description
vaccines with dendritic cells pulsed with tumor lysate
Intervention Type
Procedure
Intervention Name(s)
Surgery as needed by the patient´s tumor and stage
Intervention Type
Drug
Intervention Name(s)
Chemotherapy as needed by the patient´s tumor and stage
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy as needed by the patient´s tumor and stage
Primary Outcome Measure Information:
Title
Number and type of adverse events detected in the follow up as a measure of safety and tolerability
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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
Title
Humoral and cellular immune response as a measure of the immunogenicity of the vaccine.
Time Frame
2 weeks to 24 months
Title
Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Patiño-García, PhD
Organizational Affiliation
CUN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic of Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

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

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