scholarly journals The right immune-modulation at the right time: thymosin α1 for prevention of severe COVID-19 in cancer patients

2021 ◽  
Author(s):  
Melissa Bersanelli ◽  
Diana Giannarelli ◽  
Alessandro Leonetti ◽  
Sebastiano Buti ◽  
Marcello Tiseo ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Immune Modulation ◽  
Randomized Study ◽  
Open Label ◽  
Thymosin Α1 ◽  
Patients With Cancer ◽  
Incurable Disease ◽  
Start Up ◽  
Open Label Phase ◽  
The Right

We presented the rationale for the use of thymosin α1 as prophylaxis of severe COVID-19 in cancer patients undergoing active treatment, constituting the background for the PROTHYMOS study, a prospective, multicenter, open-label, Phase II randomized study, currently in its start-up phase (Eudract no. 2020-006020-13). We aim to offer new hope for this incurable disease, especially to frail patient population, such as patients with cancer. The hypothesis of an effective prophylactic approach to COVID-19 would have immediate clinical relevance, especially given the lack of curative approaches. Moreover, in the ‘COVID-19 vaccine race era’ both clinical and biological results coming from the PROTHYMOS trials could even support the rationale for future combinatorial approaches, trying to rise vaccine efficacy in frail individuals.

scholarly journals Oral Nutritional Supplementation for the Dietary Management of Malnutrition in Cancer: Study Protocol of A Randomized, Open-Label, Multicentre Clinical Trial

2019 ◽  
Vol 4 (07) ◽  
Author(s):  
Edit Nadasi ◽  
Gellert Cseh
Keyword(s):  
Clinical Trial ◽  
Cancer Patients ◽  
Study Protocol ◽  
Negative Energy ◽  
Malignant Diseases ◽  
Open Label ◽  
Multicentre Clinical Trial ◽  
Patients With Cancer ◽  
Extra Energy ◽  
Oral Nutritional Supplements

In cancer, more than 30% of patients die due to cachexia and more than 50% of patients with cancer die with cachexia being present. Patients with cancer cachexia frequently develop a chronic negative energy and protein balance driven by a combination of reduced food intake and metabolic change. Several studies have already demonstrated the usefulness of oral nutritional supplements (ONS) in managing malnutrition of cancer patients. Though increased energy intake is very important in managing cancer-related malnutrition, the source of this extra energy and the presence of anti-inflammatory and immunonutritional components may also play an important role. Here we present the study protocol of a randomized, open-label, multicentre clinical trial aimed to determine whether an ONS composed according to the needs of patients with malignant diseases an ONS composed according to the needs of patients with malignant diseases is more effective than a general product in improving the nutritional status in cancer patients.

scholarly journals Open randomized study of cefepime versus piperacillin-gentamicin for treatment of febrile neutropenic cancer patients.

1997 ◽  
Vol 41 (8) ◽  
pp. 1704-1708 ◽  
Author(s):  
D Yamamura ◽  
R Gucalp ◽  
P Carlisle ◽  
M Cimino ◽  
J Roberts ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Cancer Patients ◽  
Randomized Study ◽  
Response Rates ◽  
Efficacy And Safety ◽  
Open Label ◽  
Gram Negative ◽  
Underlying Malignancy ◽  
Neutropenic Patients ◽  
Febrile Episodes

An open-label randomized trial comparing the efficacy and safety of cefepime versus piperacillin plus gentamicin (P+G) given intravenously for the treatment of febrile episodes in neutropenic patients with underlying malignancy was conducted at two oncology centers. Over a 30-month period 111 patients were enrolled and 99 patients were found to be suitable for evaluation. At the 72-h time of evaluation, cefepime monotherapy and P+G combination therapy produced comparable clinical response rates (78% for both). P+G and cefepime produced comparable response rates in microbiologically documented (78 versus 71%), clinically documented (100 versus 100%), and possible (75 versus 79%) infections. The P+G and cefepime treatments achieved comparable microbiological eradication of gram-negative (100 versus 71%) (P = 0.09) and gram-positive (44 versus 70%) (P = 0.37) organisms. There were no statistically significant differences in the rates of superinfection between the groups; however, more superinfections of fungal origin were noted in the P+G group. Cefepime was demonstrated to be an effective and safe treatment for febrile episodes in neutropenic patients with malignancies, and its lack of nephrotoxicity compared to P+G was noteworthy. Cefepime appears to be a candidate for monotherapy in febrile neutropenic cancer patients.

scholarly journals Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer

2016 ◽  
Vol 115 (7) ◽  
pp. 789-796 ◽  
Author(s):  
Angus G Dalgleish ◽  
Justin Stebbing ◽  
Douglas JA Adamson ◽  
Seema Safia Arif ◽  
Paolo Bidoli ◽  
...  
Keyword(s):  
Phase Ii ◽  
Immune Modulation ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Similar Rate ◽  
Adverse Event Reporting ◽  
Ductal Adenocarcinoma ◽  
Open Label ◽  
Open Label Phase ◽  
Intent To Treat

Abstract Background: Immune Modulation and Gemcitabine Evaluation-1, a randomised, open-label, phase II, first-line, proof of concept study (NCT01303172), explored safety and tolerability of IMM-101 (heat-killed Mycobacterium obuense; NCTC 13365) with gemcitabine (GEM) in advanced pancreatic ductal adenocarcinoma. Methods: Patients were randomised (2 : 1) to IMM-101 (10 mg ml−l intradermally)+GEM (1000 mg m−2 intravenously; n=75), or GEM alone (n=35). Safety was assessed on frequency and incidence of adverse events (AEs). Overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) were collected. Results: IMM-101 was well tolerated with a similar rate of AE and serious adverse event reporting in both groups after allowance for exposure. Median OS in the intent-to-treat population was 6.7 months for IMM-101+GEM v 5.6 months for GEM; while not significant, the hazard ratio (HR) numerically favoured IMM-101+GEM (HR, 0.68 (95% CI, 0.44–1.04, P=0.074). In a pre-defined metastatic subgroup (84%), OS was significantly improved from 4.4 to 7.0 months in favour of IMM-101+GEM (HR, 0.54, 95% CI 0.33–0.87, P=0.01). Conclusions: IMM-101 with GEM was as safe and well tolerated as GEM alone, and there was a suggestion of a beneficial effect on survival in patients with metastatic disease. This warrants further evaluation in an adequately powered confirmatory study.

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