First step results from a phase II study of a dendritic cell vaccine in glioblastoma patients (CombiG-vax).

Background: Glioblastoma (GBM) is a poor prognosis grade 4 glioma. After surgical resection, the standard therapy consists of concurrent radiotherapy (RT) and temozolomide (TMZ) followed by TMZ alone. Our previous data on melanoma patients showed that Dendritic Cell vaccination (DCvax) could increase the amount of intratumoral-activated cytotoxic T lymphocytes. Methods: This is a single-arm, monocentric, phase II trial in two steps according to Simon's design. The trial aims to evaluate progression-free survival (PFS) at three months and the safety of a DCvax integrated with standard therapy in resected GBM patients. DCvax administration begins after completion of RT-CTwith weekly administrations for 4 weeks, then is alternated monthly with TMZ cycles. The primary endpoints are PFS at three months and safety. One of the secondary objectives is to evaluate the immune response both in vitro and in vivo (DTH skin test). Results: By December 2022, the first pre-planned step of the study was concluded with the enrollment, treatment and follow up of 9 evaluable patients. Two patients had progressed within three months after leukapheresis, but none had experienced DCvax-related G3-4 toxicities Five patients experienced a positive DTH test towards KLH and one of these also towards autologous tumor homogenate. The median PFS from leukapheresis was 11.3 months and 12.2 months from surgery. Conclusions: This combination therapy is well-tolerated, and the two endpoints required for the first step have been achieved. Therefore, the study will proceed to enroll the remaining 19 patients. (Eudract number: 2020-003755-15 https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003755-15/IT).

Pharmacy Workload in Clinical Trial Management: A Preliminary Complexity Assessment Tool for Sponsored Oncology and Haematology Trials.

Investigational drug services need to be organised in a structured approach, especially for sites with a large number of ongoing clinical trials. The aim of this study was to develop a tool to assess the complexity of pharmacy involvement in a sponsored oncology clinical trial. Categorisation into ordinal complexity categories was used to assess the complexity of the clinical trials for consistent pharmacy grant applications. The 15 items of the tool were divided into three sections, and individual item scores were agreed upon among four pharmacists with experience in the conduct of clinical trials at two different centres. A final version of the tool, named Pharm-CAT, was approved. The pharmacists were instructed to use Pharm-CAT to assign a score to each new sponsored trial. To determine the cut-offs for the complexity categories, the scores were sorted in ascending order and the cut-offs corresponding to the first and third tertiles of the score distribution were selected. To verify the reproducibility of the results, Pharm-CAT was applied by two pharmacists independently for each trial. Pharm-CAT proved to be user-friendly. Sixty clinical trials were evaluated and a total of 120 scores were recorded. Low-complexity scores ranged from 0 to 19, medium-complexity scores ranged from 20 to 25, and high-complexity scores were 26 or higher. The average score recorded was 22.88 points. Prospective multicentre validation of Pharm-CAT is needed to confirm its applicability.

The Comprehensive Cancer Care Network of Romagna: the opportunities generated by the OECI accreditation program.

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS is a public-private partnership among 3 public sector bodies and 6 private nonprofit organizations and represents the hub of the Oncology Network of Romagna, which provides a wide range of services for the population ranging from primary prevention to palliative care. In 2012, IRST took part in the ministerial research project of the Organisation of European Cancer Institutes (OECI) accreditation program for Comprehensive Cancer Centers. The self-assessment period lasted 6 months and was coordinated by a multidisciplinary project team headed by a project leader. Each project team member coordinated a subgroup whose task was to analyze specific standards from qualitative and quantitative questionnaires. During the self-assessment period for the areas in which IRST did not meet OECI requirements, the project team outlined several improvement plans. At the end of the self-assessment period, the OECI Accreditation & Designation Board approved the documentation presented by IRST and a peer review visit was scheduled. The OECI report suggested establishing a more specific and stronger centralized management and leadership of all the oncologic activities carried out in other centers. In accordance with these suggestions, IRST and the Local Health Authority of Romagna laid the foundations for a new management model for the Oncology Network of Romagna: the Comprehensive Cancer Care Network (CCCN). The CCCN is a territory-oriented model (population approach) based on a principle of cooperation and collaboration among the network nodes.