A Phase II Study on Adjuvant Vaccination With Dendritic Cells Loaded With Autologous Tumor Homogenate in Resected Stage IV Rare Cancers. (RaC-Ad)
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|ClinicalTrials.gov Identifier: NCT04166006|
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Head Neck Tumors Neuroendocrine Tumors Soft Tissue Sarcoma Rare Cancer Vaccination||Biological: Autologous DC vaccine Drug: Interleukin-2||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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).|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2026|
7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1), followed by Interleukin (IL) - 2 (IL-2), at a dose of 3 Million Units (MU), given by subcutaneous injection daily for five days (days 3-7). This constitutes a treatment cycle.
Treatment cycles are repeated every 28 days up to a maximum of six cycles.
Biological: Autologous DC vaccine
7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)
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).
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: from the day of the leukapheresis up to 30 days after the last dose ]Incidence, type and severity of adverse events occurred during treatment will be reported and graded according to NCI CTCAE 5.0 criteria
- Immunological efficacy [ Time Frame: at 4 months, after at least 3 vaccinations ]immunological efficacy will be assessed as a proportion of tumor-specific circulating immune effectors determined by IFNgamma ELISPOT
- Overall Survival (OS) [ Time Frame: Up to 7 years ]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) [ Time Frame: Up to 7 years ]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 [ Time Frame: Up to 7 years ]Evaluation of the predictive role of a positive DTH test after at least three vaccine administrations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166006
|Contact: Oriana Nanni, DRemail@example.com|
|Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)||Not yet recruiting|
|Meldola, FC, Italy, 47014|
|Contact: Laura Ridolfi, MD +390543739274 firstname.lastname@example.org|
|Study Chair:||Laura Ridolfi, MD||Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)|