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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04166006
Other study ID # IRST100.42
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 12, 2019
Est. completion date December 2026

Study information

Verified date April 2020
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact Oriana Nanni, DR
Phone +390543739266
Email oriana.nanni@irst.emr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

This is a single-arm, multi-cohort phase II study, to evaluate the immunological effectiveness and safety of adjuvant Dendritic Cell (DC) vaccination. The evaluation of immunological efficacy will be expressed as the number of patients who show enhancement of the proportion of circulating immune effectors specific for a selected panel of associated antigens for each disease (HNSCC, NET and STS). To avoid unacceptable toxicity, a formal safety analysis will be conducted after six patients have been observed (two for each disease) for at least 30 days after the third treatment cycle. If two or more patients have experienced grade 3 or higher adverse events, enrollment will be definitively stopped; differently, other 15 patients for each disease will be enrolled and evaluation of primary objectives will be done for each cohort separately (H&N, STS and NET).


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Study Design


Intervention

Biological:
Autologous DC vaccine
7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)
Drug:
Interleukin-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

Country Name City State
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Meldola FC

Sponsors (1)

Lead Sponsor Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 from the day of the leukapheresis up to 30 days after the last dose
Primary Immunological efficacy immunological efficacy will be assessed as a proportion of tumor-specific circulating immune effectors determined by IFNgamma ELISPOT at 4 months, after at least 3 vaccinations
Secondary 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. Up to 7 years
Secondary 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. Up to 7 years
Secondary 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 Up to 7 years
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