NCT04166006

A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers.

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).

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Head Neck Tumors
• Neuroendocrine Tumors
• Soft Tissue Sarcoma
• Rare Cancer
• Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	Autologous DC vaccine	7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)
DRUG	Interleukin-2	Autologous DC vaccine is followed by IL-2, at a dose of 3 MU, given by subcutaneous injection daily for five days (days 3-7).

Timeline

• Start date: 2019-12-12
• Primary completion: 2027-04-01
• Completion: 2031-12-01
• First posted: 2019-11-18
• Last updated: 2024-09-19

Locations

1 site across 1 country: Italy