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).
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)
• The patient must have recovered from all the adverse events related to previous surgery.
• Age ≥18 years.
• Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1.
• Patient must have acceptable organ function, defined as:
∙ Haemoglobin \>10 g/dl
‣ White blood cells ≥3000/μl.
‣ Absolute neutrophil count ≥1500/μl.
‣ Platelets≥75000/μl.
‣ aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3 times the upper institutional reference level.
‣ Total bilirubin \<1.5 times the upper institutional reference level.
‣ Serum creatinine \<1.5 times the upper institutional reference level.
• Patients aged 70 years or older must have left ventricular ejection fraction not lower than 55% as assessed by echocardiography.
⁃ Female patients of childbearing potential and all male patients must accept and be compliant with an highly effective contraceptive method (i.e. with a failure rate of \<1% per year: double barrier method, one barrier method plus spermicidal, intrauterine device, or oral contraception) from informed consent signature and up to three months after end of study. For this purpose are considered of childbearing potential all female subjects after puberty unless they are post-menopausal for at least two years or are surgically sterile. Complete abstinence from sexual intercourses is acceptable if patients' lifestyle guarantees his/her strict compliance with this prescription in the judgement of the Investigator.
⁃ The patient is willing and able to give written informed consent for the study.