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Trial of FOLF(HA)Iri With Cetuximab in mCRC

ABSTRACT: As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced efficacy in both nonclinical and early clinical studies. The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild type metastatic colorectal cancer. The study objectives are to confirm the safety and efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic colorectal cancer patients. It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent treatment and follow up; thus the trial will run for approximately 2-3 years.

DISEASE(S): Metastatic Colorectal Cancer,Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2172573 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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HA-Irinotecan Solution for Infusion in Patients with Metastatic Colorectal Cancer

Project description:Primary objectives: To demonstrate that FOLF(HA)iri is superior to FOLFIRI in prolonging progression free survival (PFS) of irinotecan-naïve patients with metastatic colorectal cancer in the second or third line treatment setting. Primary endpoints: The primary efficacy outcome is PFS based on tumor response assessments established by the independent radiology reviewers

| 2528184 | ecrin-mdr-crc

Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC

Project description:Trial design: * Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen. * Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve. * Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom). * Dosing regimen: * Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan and HA-Irinotecan dose in must be reduced to 150 mg/m2). * Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan. * 5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion. * Repeat every 2 weeks for 8 months. * Patient accrual over approximately 12-14 months. * Monitoring to 18 months post-randomization. * 390 patients. * Progression Free Survival (PFS) primary endpoint. * Safety analysis on the initial 20 patients.

| 2101890 | ecrin-mdr-crc

Ischemia reperfusion injury (IRI) in organ transplantation and the effects of carbon monoxide treatment

Project description:Ischemia reperfusion injury (IRI) in organ transplantation remains a significant problem with limited alternative therapeutic options. Organs that undergo significant damage during IRI, particularly those enduring long warm ischemia times, undergo significant delayed graft function (DGF) after reperfusion and tend to have greater complications long term with the onset of chronic rejection. The gas molecule carbon monoxide (CO) has emerged as an agent that can suppress IRI in rodent models of solid organ transplantation. Since the use of CO is a potential therapeutic modality in humans, we tested if CO can prevent DGF in a pig model of kidney transplantation Keywords: stress response, treatment response 18 Samples from pig kidneys, two naïve controls, two timepoints, two conditions, 4 replicates

2009-01-20 | E-GEOD-14373 | biostudies-arrayexpress

CRC Primary tumours with Kras status

Project description:FFPE primary CRC biopsies were harvested and run on the CRC DSA (Almac Diagnostics, UK). All primary tumours were pre-treatment and all patients developed progressive disease. Full patient response data to 5-FU/irinotecan treatment is measured in the advanced disease setting.

2012-04-30 | E-MEXP-3549 | biostudies-arrayexpress

TAS-102, Irinotecan, and Bevacizumab in Pre-treated Metastatic Colorectal Cancer (TABAsCO), A Phase II Clinical Trial. ClinicalTrials.gov NCT04109924

Project description:Background: The efficacy of FOLFIRI plus an antiangiogenesis biologic agent as 2nd line therapy for metastatic colorectal adenocarcinoma is limited. TAS-102 is a novel oral antimetabolite with a distinct mechanism of action from fluoropyrimidines. We evaluated the antitumor efficacy of TAS-102, irinotecan and bevacizumab in patients with pre-treated, advanced colorectal adenocarcinoma in a multicenter, phase II, single-arm study. Methods: Patients with advanced colorectal adenocarcinoma who had progressed after oxaliplatin and fluoropyrimidine and were eligible for treatment with bevacizumab were treated with irinotecan, bevacizumab, and TAS-102 in 28-day cycles. The primary endpoint was progression-free survival (PFS). Results: We enrolled 35 evaluable patients. The study was positive. The median PFS was 7.9 (90% CI 6.2-11.8) months (vs. 6 months in historical control, p=0.018). The median overall survival was 16.5 (90% CI 9.8-17.5) months. Sixty-seven percent of patients experienced grade 3 or higher treatment-related adverse events. The most common toxicities were hematological (neutropenia) and gastrointestinal (diarrhea, nausea, and vomiting). Conclusions: Irinotecan, TAS-102 and bevacizumab is an active 2nd line therapy for patients with metastatic colorectal adenocarcinoma. Neutropenia is common and can affect dose density/intensity mandating use of G-CSF. A randomized study versus standard of care therapy is warranted.

2024-08-26 | GSE275628 | GEO

Nanoparticle-coupled topical methotrexate effectively inhibits inflammation and induces re-modeling in pre-clinical psoriasis

Project description:This project explores the efficacy of a novel skin-permeable MTX formulation, on murine and human xenotransplant models of psoriasis. Phenotypical and histological examinations of psoriatic tissue in these models have shown that the novel MTX can significantly suppress the inflammation. In order to understand the mechanistics of the new drug transcriptome of different treatment regimens (MTX-based, corticosteroid-based, and Vaseline control) will be compared to assess the pathological state of the skin.

2019-11-05 | GSE126066 | GEO

Deciphering and predicting CD4+ T cell immunodominance of Influenza virus hemagglutinin

Project description:The importance of CD4+ T helper (Th) cells is well appreciated in view of their essential role in the elicitation of antibody and cytotoxic T cell responses. However, the mechanisms that determine the selection of immunodominant epitopes within complex protein antigens remain elusive. Here, we used ex vivo stimulation of memory T cells and screening of naïve and memory T cell libraries, combined with T cell cloning and TCR sequencing, to dissect the human naïve and memory CD4+ T cell repertoire against the influenza pandemic H1 hemagglutinin (H1-HA). We found that naïve CD4+ T cells have a broad repertoire, being able to recognize naturally processed as well as cryptic peptides spanning the whole H1-HA sequence. In contrast, memory Th cells were primarily directed against just a few immunodominant peptides that were readily detected by mass spectrometry-based MHC-II peptidomics and predicted by structural accessibility analysis. Collectively, these findings reveal the presence of a broad repertoire of naïve T cells specific for cryptic H1-HA peptides, and demonstrate that antigen processing represents a major constraint determining immunodominance.

2020-06-29 | PXD018151 | Pride

Transcription profiling of topoisomerase I inhibitor irinotecan (CPT-11) sensitive, resistant, and reverted human neuroblastomas

Project description:We have established a neuroblastoma model resistant in vivo to the topoisomerase I inhibitor irinotecan (CPT-11, Camptothecin-11, CAMPTOSAR®) in order to study resistance to these agents acquired in a therapeutic setting. Common mechanisms of resistance were not involved in this model and we thus explored the gene expression signature associated with resistance by comparing the transcriptomes of sensitive, resistant, and reverted tumours using high-throughput DNA microarrays.

2008-01-26 | E-TABM-211 | biostudies-arrayexpress

Randomised Phase II trial of irinotecan with hyaluronic acid (HyCAMP) versus irinotecan as treatment for patients with metastatic colorectal cancer who have failed 5-FU based chemotherapy

Project description:Interventions: This is an open-label, randomized Phase II study of HyCAMP versus irinotecan as second-line or subsequent-line treatment for metastatic colorectal cancer, for patients who have previously received 5-FU based chemotherapy. The mixture of HA and irinotecan will be given by intravenous infusion on day 1 of a 3-week cycle, up to a maximum of 8 cycles, with the control arm receiving irinotecan alone in the same treatment schedule. The treatment dose of HyCAMP has been shown to be safe in a recently completed Phase I study combining irinotecan with HA. Patients will be randomized in a 1:1 fashion to either 1) HyCAMP (irinotecan and HA) or 2) Control arm (irinotecan) Primary outcome(s): Incidence of Grade 3 and 4 diarrhoea[] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

| 2451960 | ecrin-mdr-crc

Foxd3 promotes the exit from naïve pluripotency and prevents germline specification through enhancer decommissioning [ChIP-Seq]

Project description:Following implantation, mouse epiblast cells transit from a naïve to a primed state in which they are competent for both somatic and primordial germ cell (PGC) specification. Using mouse embryonic stem cells (mESC) as an in vitro model to study the transcriptional regulatory principles orchestrating peri-implantation development, here we show that the transcription factor Foxd3 is necessary for the exit from naïve pluripotency and the progression to a primed pluripotent state. During this transition, Foxd3 acts as a repressor that dismantles a significant fraction of the naïve pluripotency expression program through the decommissioning of active enhancers associated with key naïve pluripotency and early germline genes. Subsequently, Foxd3 needs to be silenced in primed pluripotent cells to allow the reactivation of relevant genes required for proper PGC specification. Our findings uncover a wave of activation-deactivation of Foxd3 as a crucial step for the exit from naïve pluripotency and subsequent PGC specification. Genome-wide binding profiles for Foxd3 were investigated in mouse embryonic stem cells (mESC). A mESC line (FH-Foxd3 mESC line) expressing exogenous Foxd3 tagged with Flag and HA epitope (FH-Foxd3) at nearly endogenous levels was generated. ChIPs were performed against FH-Foxd3 using anti-HA or anti-Flag antibodies.

2015-09-14 | E-GEOD-70545 | biostudies-arrayexpress

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