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).
Patients must have histologically confirmed stage IV Head&Neck Squamous Cell Carcinoma (HNSCC), NeuroEndocrine Tumors (NET) or Soft Tissue Sarcoma (STS) surgically treated with radical intent.
The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab and must fulfil all the acceptance criteria prescribed by the Good Manufactory Practice (GMP) procedures.
The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations.
Patients disease-free candidates for only observation as per clinical practice (no standard treatment is available after surgery)
Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.
Patient who completed surgery more than 90 days before study enrolment.
History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with curative surgery.
History of congenital or acquired immunodeficiency, including history of organ transplantation.
Single group
Autologous DC vaccine
Biological/Vaccine7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)
Interleukin-2
DrugAutologous DC vaccine is followed by IL-2, at a dose of 3 MU, given by subcutaneous injection daily for five days (days 3-7).
Incidence of Treatment-Emergent Adverse Events
Incidence, type and severity of adverse events occurred during treatment will be reported and graded according to NCI CTCAE 5.0 criteria
Immunological efficacy
immunological efficacy will be assessed as a proportion of tumor-specific circulating immune effectors determined by IFNgamma ELISPOT
Overall Survival (OS)
OS is the time from registration to the time of death from any cause. Subjects who are alive at the time of the final analysis or who have become lost to follow-up will be censored at their last known alive date.
Relapse Free Survival (RFS)
RFS is the time from registration to the first date of documented progression (or death for any causes). Subject without progression will be censored at their last tumor assessment date.
Predictive role of Delayed-Type Hypersensitivity (DTH) skin test
Evaluation of the predictive role of a positive DTH test after at least three vaccine administrations
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