- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02496520
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
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
-
-
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
|
vaccines with dendritic cells pulsed with tumor lysate
|
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.
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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