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

NCT02496520 | Completed Phase 1 DMC

• 2 other identifiers: DEND/TIA2013-003632-71
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Central Nervous System Tumor

Keywords

dendritic cell vaccination; sarcoma; central nervous system tumor; childhood; adolescent; immunotherapy

Outcome Measures

Primary Outcomes (1)

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

  24 months

Secondary Outcomes (3)

• Event free progression, overall survival, time to progression and number and size of existent tumoral lesions as measures of clinical efficacy

  36 months

• Humoral and cellular immune response as a measure of the immunogenicity of the vaccine.

  2 weeks to 24 months

• Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires.

  36 months

Study Arms (1)

Vaccines with autologous dendritic cells

EXPERIMENTAL

Vaccines with autologous dendritic cells

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

Interventions

dendritic cells BIOLOGICAL

vaccines with dendritic cells pulsed with tumor lysate

Vaccines with autologous dendritic cells

Surgery as needed by the patient´s tumor and stage PROCEDURE

Vaccines with autologous dendritic cells

Chemotherapy as needed by the patient´s tumor and stage DRUG

Vaccines with autologous dendritic cells

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

Vaccines with autologous dendritic cells

Eligibility Criteria

• Age: 3 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

University Clinic of Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Sarcoma; Central Nervous System Neoplasms

Interventions

Surgical Procedures, Operative; Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ana Patiño-García, PhD

  CUN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 14, 2015
• Study Start: September 30, 2014
• Primary Completion: September 16, 2018
• Study Completion: May 27, 2019
• Last Updated: February 21, 2020

Record last verified: 2019-05

Locations

ES (1)