RecruitingPhase 2NCT04166006

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).


Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Enrollment

51 participants

Start Date

Dec 12, 2019

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine made from a patient's own tumor tissue for people with rare stage IV cancers who have had surgery to remove the tumor. The vaccine uses dendritic cells (immune cells) loaded with proteins from the patient's own tumor to train the immune system to recognize and attack any remaining cancer cells. It is being tested in head and neck cancer, neuroendocrine tumors, and soft tissue sarcomas. **You may be eligible if...** - You have been surgically treated for stage IV head and neck squamous cell carcinoma, neuroendocrine tumor, or soft tissue sarcoma with the intent to cure - Your surgeon collected and sent your tumor tissue to the lab to make the vaccine - After surgery, imaging shows you are currently free of disease - Standard medical practice would recommend observation only (no additional chemotherapy or radiation) **You may NOT be eligible if...** - Your tumor tissue was not collected or did not meet quality standards for vaccine production - You have evidence of remaining disease after surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous DC vaccine

7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)

DRUGInterleukin-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).


Locations(1)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, Italy

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NCT04166006


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