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A Phase II Study on Adjuvant Vaccination With Dendritic Cells Loaded With Autologous Tumor Homogenate in Resected Stage IV Rare Cancers. — RaC-Ad  

Neuroendocrine Tumors Clinical Trial

Official title:
A Phase II Study on Adjuvant Vaccination With Dendritic Cells Loaded With Autologous Tumor Homogenate in Resected Stage IV Rare Cancers: Head&Neck (H&N), Neuroendocrine Tumors (NET) and Soft Tissue Sarcoma (STS).

Clinical Trial Summary

Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV rare cancers (In Head/Neck tumors (H&N), NEuroendocrine Tumors (NET) and Soft Tissue Sarcomas (STS).

Clinical Trial Description

This is a single-arm, multi-cohort phase II study, to evaluate the immunological effectiveness and safety of adjuvant Dendritic Cell (DC) vaccination. The evaluation of immunological efficacy will be expressed as the number of patients who show enhancement of the proportion of circulating immune effectors specific for a selected panel of associated antigens for each disease (HNSCC, NET and STS). To avoid unacceptable toxicity, a formal safety analysis will be conducted after six patients have been observed (two for each disease) for at least 30 days after the third treatment cycle. If two or more patients have experienced grade 3 or higher adverse events, enrollment will be definitively stopped; differently, other 15 patients for each disease will be enrolled and evaluation of primary objectives will be done for each cohort separately (H&N, STS and NET). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04166006
Study type Interventional
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact Oriana Nanni, DR
Phone +390543739266
Email oriana.nanni@irst.emr.it
Status Recruiting
Phase Phase 2
Start date December 12, 2019
Completion date December 2026
View Details
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