NCT02919644

Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.

Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer: a Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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 colorectal cancer

Detailed description

Vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer: a phase II study. Primary objectives: Safety Immunological efficacy, expressed as number of patients who show enhancement of the proportion of circulating immune effectors specific for a selected panel of Colon-Rectal Cancer (CRC)-associated antigens. Secondary objectives: Clinical outcome of the patients (OS, RFS, TTR). To evaluate the predictive role of the development of a positive DTH test after at least three vaccine administrations. To evaluate the persistence of an antitumor immune response after the completion of the vaccination program. To evaluate the prognostic or predictive role of the enhancement of a specific immune response. To evaluate a panel of inflammatory cytokines involved in antitumor immune response. To evaluate the predictive role of immune cells in tumour microenvironment. To evaluate the predictive role of tumour antigen expression. This is a two-stage, phase 2 clinical trial designed according to Simon minimax design. A 40% immune response rate would preclude further studies, while a 70% immune response rate would indicate that further studies would be warranted. Given α and β error of 0.1, the first stage will require enrolment of 7 patients. If at least 3 patients show an immune response and toxicity is acceptable, the study will proceed to the second stage and additional 12 patients will be enrolled. The vaccine will be considered immunologically active if at least 11 patients are immunological responders.

Conditions

• Stage IV Colorectal Cancer
• Curative Resection

Interventions

Type	Name	Description
BIOLOGICAL	autologous dendritic cells loaded with autologous tumour homogenate	Each vaccine dose consists of 10\_7 autologous dendritic cells loaded with autologous tumor homogenate
DRUG	IL2	Each vaccine dose is followed, after two days, by IL-2 as adjuvant, at a dose of 3 MU daily for five consecutive days

Timeline

• Start date: 2016-12-02
• Primary completion: 2026-12-01
• Completion: 2031-12-01
• First posted: 2016-09-29
• Last updated: 2024-09-19

Locations

2 sites across 1 country: Italy