A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers Head Neck, Neuroendocrine Tumors, and Soft Tissue Sarcoma

What this Trial Is About

Researchers are investigating the safety and immune response of an adjuvant vaccination using a patients own dendritic cells loaded with tumor material after surgery for stage IV rare cancers, including Head and Neck tumors, Neuroendocrine Tumors, and Soft Tissue Sarcomas. This phase II, single-arm study aims to measure the increase in specific immune cells related to these cancers and monitor treatment safety carefully to prevent significant side effects. Participants receive treatment cycles starting with an intradermal injection of 7 to 14 million autologous dendritic cells loaded with their own tumor homogenate on day 1. This is followed by subcutaneous injections of Interleukin-2 at 3 million units daily for five days days 3-7. Each treatment cycle lasts 28 days, with up to six cycles administered. The study includes a safety review after the first six patients complete three cycles, followed by enrollment of additional patients if safety criteria are met. During the study, participants undergo various assessments including CT scans or MRI to confirm no disease presence before starting. Researchers monitor treatment-emergent adverse events from leukapheresis day through 30 days after the last dose and measure immunological effects after at least three vaccinations. Secondary outcomes include overall survival, relapse-free survival, and skin test responses, with follow-up extending up to seven years. Participants are closely observed for safety and immune response throughout the study period.

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