A phase II study on adjuvant Vaccination with dendritic cells in resected stage IV rare cancers: Head&Neck (H&N), neuroendocrine Tumors (NET) and soft tissue sarcoma (STS).

Phase 1

• Conditions: Resected stage IV rare cancers: Head&Neck (H&N), neuroendocrine tumors (NET) and soft tissue sarcoma (STS).; MedDRA version: 21.1Level: PTClassification code 10071536Term: Head and neck cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10068771Term: Soft tissue neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000793-27-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Histologically confirmed stage IV rare cancers: Head&Neck Squamous Cell Carcinoma (HNSCC), Neuroendocrine Tumors (NET) and 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 of IRST IRCCS and must fulfil all the acceptance criteria prescribed by the GMP procedures.
• The patient must be disease-free, candidates for only observation as per clinical practice (no standard treatment is available after surgery).
• Age >=18 years.
• ECOG performance status 0 or 1.
• Acceptable organ function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified