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Completed

NCT Number: NCT02496520

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

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.

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Key information

Conditions

Sarcoma Central Nervous System Neoplasms Central Nervous System Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Nervous System Diseases Nervous System Neoplasms

Age range

3 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Clinic of Navarra

Pamplona, Navarre, 31008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dendritic Cells

Biological

vaccines with dendritic cells pulsed with tumor lysate

Surgery as needed by the patient´s tumor and stage

Procedure

Chemotherapy as needed by the patient´s tumor and stage

Drug

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

Radiation

Primary outcomes

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

    Time frame: 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Acronym: DEND/TIA

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jul 14, 2015
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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