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

Sarcoma Clinical Trial

— DEND/TIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496520
• Other study ID #: DEND/TIA
• Secondary ID: 2013-003632-71
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 30, 2014
• Est. completion date: May 27, 2019

Study information

• Verified date: May 2019
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 27, 2019
• Est. primary completion date: September 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Nervous System Neoplasms
• Sarcoma

Intervention

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

Locations

Country	Name	City	State
Spain	University Clinic of Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and type of adverse events detected in the follow up as a measure of safety and tolerability		24 months
Secondary	Event free progression, overall survival, time to progression and number and size of existent tumoral lesions as measures of clinical efficacy		36 months
Secondary	Humoral and cellular immune response as a measure of the immunogenicity of the vaccine.		2 weeks to 24 months
Secondary	Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires.		36 months