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

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ClinicalTrials.gov Identifier: NCT02496520
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

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.

Condition or disease Intervention/treatment Phase
Sarcoma Central Nervous System Tumor Biological: dendritic cells 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 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaccines with autologous dendritic cells
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



Primary Outcome Measures :
  1. Number and type of adverse events detected in the follow up as a measure of safety and tolerability [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Humoral and cellular immune response as a measure of the immunogenicity of the vaccine. [ Time Frame: 2 weeks to 24 months ]
  3. Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires. [ Time Frame: 36 months ]


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Ages Eligible for Study:   3 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02496520


Contacts
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Contact: Ana Patiño-García, PhD 34948255400 ext 4257 apatigar@unav.es

Locations
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Spain
University Clinic of Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Ana Patiño-García, PhD    +34948255400 ext 4257    apatigar@unav.es   
Contact: Susana Inogés, MD, PhD    +34948255400 ext 5167    sinoges@unav.es   
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
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Principal Investigator: Ana Patiño-García, PhD CUN

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT02496520     History of Changes
Other Study ID Numbers: DEND/TIA
2013-003632-71 ( EudraCT Number )
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
dendritic cell vaccination
sarcoma
central nervous system tumor
childhood
adolescent
immunotherapy

Additional relevant MeSH terms:
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Sarcoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Nervous System Diseases