scholarly journals Oral birch pollen immunotherapy with apples: Results of a phase II clinical pilot study

2021 ◽  
Author(s):  
Bettina Nothegger ◽  
Norbert Reider ◽  
Claudia E. Covaciu ◽  
Valentina Cova ◽  
Linda Ahammer ◽  
...  
Keyword(s):  
Pilot Study ◽  
Phase Ii ◽  
Birch Pollen

scholarly journals Safety and efficacy of faecal microbiota transplantation by Anaerobic Cultivated Human Intestinal Microbiome (ACHIM) in patients with systemic sclerosis: study protocol for the randomised controlled phase II ReSScue trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048541
Author(s):  
Anna-Maria Hoffmann-Vold ◽  
Håvard H Fretheim ◽  
Vikas K Sarna ◽  
Imon Barua ◽  
Maylen N Carstens ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Pilot Study ◽  
Phase Ii ◽  
Intestinal Microbiome ◽  
Induction Phase ◽  
Inflammatory Disorder ◽  
Faecal Microbiota ◽  
Safety And Efficacy ◽  
Faecal Microbiota Transplantation ◽  
Patient Reported

IntroductionIn the multisystem inflammatory disorder systemic sclerosis (SSc), gastrointestinal tract (GIT) affliction is highly prevalent. There are no known disease modifying therapies and the negative impact is substantial. Aiming for a new therapeutic principle, and inspired by recent work showing associations between gut microbiota changes and GIT symptoms in SSc, we performed a pilot study on faecal microbiota transplantation (FMT) with the single-donor bacterial culture ‘Anaerobic Cultivated Human Intestinal Microbiome (ACHIM)’. Motivated by positive pilot study signals, we designed the ReSScue trial as a phase II multicentre, placebo-controlled, randomised 20-week trial to evaluate safety and efficacy on lower GIT symptoms of FMT by ACHIM in SSc.Methods and analysesWe aim to include 70 SSc participants with moderate to severe lower GIT symptoms, defined by the validated patient-reported University of California Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 2.0 questionnaire. The trial includes three parts. In part A1 (induction phase) lasting from week 0 to week 12, participants will be randomised 1:1 to repeat infusions of 30 mL ACHIM or placebo at week 0 and 2 by gastroduodenoscopy. In part A2, which is an 8-week subsequent maintenance phase, all study participants will receive 30 mL ACHIM at week 12 and followed until week 20 on continued blind. In part B, which will last until the last participant completes part A2, the participants will be followed through a maximum 16-week extended monitoring period, for longer-term data on safety and intervention effects. Primary endpoint is change from baseline to week 12 in UCLA GIT subscale scores of diarrhoea or bloating, depending on the worst symptom at baseline evaluated separately for each patient. Secondary endpoints are safety measures and changes in UCLA GIT scores (total, diarrhoea and bloating).Ethics and disseminationThis protocol was approved by the Northern Norwegian Committee for Medical Ethics. Study findings will be published.Trial registration numberNCT04300426; Pre-results.Protocol versionV.3.1.

Lycopene for Advanced Hormone Refractory Prostate Cancer: A Prospective, Open Phase II Pilot Study

2009 ◽  
Vol 181 (3) ◽  
pp. 1098-1103 ◽  
Author(s):  
Carla Schwenke ◽  
Burkhard Ubrig ◽  
Petra Thürmann ◽  
Christian Eggersmann ◽  
Stephan Roth
Keyword(s):  
Prostate Cancer ◽  
Pilot Study ◽  
Phase Ii ◽  
Hormone Refractory Prostate Cancer ◽  
Open Phase ◽  
Hormone Refractory

P134 A phase II pilot study of sorafenib in patients with myelodysplastic syndromes

2009 ◽  
Vol 33 ◽  
pp. S137
Author(s):  
C. de Castro ◽  
D. Adams ◽  
D. Rizzieri ◽  
J. Moore ◽  
J. Gockerman ◽  
...  
Keyword(s):  
Pilot Study ◽  
Phase Ii ◽  
Myelodysplastic Syndromes

Evaluating the Financial Impact of Clinical Trials in Oncology: Results From a Pilot Study From the Association of American Cancer Institutes/Northwestern University Clinical Trials Costs and Charges Project

2000 ◽  
Vol 18 (15) ◽  
pp. 2805-2810 ◽  
Author(s):  
Charles L. Bennett ◽  
Tammy J. Stinson ◽  
Victor Vogel ◽  
Lyn Robertson ◽  
Donald Leedy ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pilot Study ◽  
Medical Care ◽  
Phase Ii ◽  
Third Party ◽  
Disease Stage ◽  
Cancer Center ◽  
Policy Debate ◽  
Economic Analyses

PURPOSE: Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. METHODS: Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. RESULTS: The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P = .4) CONCLUSION: Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

scholarly journals A Phase II Single Arm Pilot Study of the CHK1 Inhibitor Prexasertib ( LY2606368 ) in BRCA Wild‐Type , Advanced Triple‐Negative Breast Cancer

2020 ◽  
Vol 25 (12) ◽  
pp. 1013
Author(s):  
Margaret E. Gatti‐Mays ◽  
Fatima H. Karzai ◽  
Sanaz N. Soltani ◽  
Alexandra Zimmer ◽  
Jeffrey E. Green ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Pilot Study ◽  
Phase Ii ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Wild Type ◽  
Chk1 Inhibitor

scholarly journals CTNI-43. ANLOTINIB COMBINED WITH STUPP REGIMEN IN TREATING PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME: A PHASE II PILOT STUDY

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii52-ii52
Author(s):  
Shuzhen Lai ◽  
Yuanyuan Chen
Keyword(s):  
Pilot Study ◽  
Glioblastoma Multiforme ◽  
Adjuvant Therapy ◽  
Disease Progression ◽  
Phase Ii ◽  
Signal Pathways ◽  
Severe Toxicity ◽  
Newly Diagnosed ◽  
Newly Diagnosed Glioblastoma ◽  
Grade 3

Abstract PURPOSE Anlotinib, an orally multi-target tyrosine kinase inhibitor, inhibits tumor angiogenic and proliferative signal pathways. We performed a phase II trial of anlotinib in combination with the STUPP regimen in patients with newly diagnosed glioblastoma multiforme（GBM）to determine whether the combination therapy would safely improve outcomes in this group of patients. An initial pilot study assessed interim safety and tolerability. METHODS AND MATERIALS Ten newly diagnosed GBM patients were included in this study. All patients received standard radiation of 60 Gy in 30 fractions starting within 4–6 weeks after surgery with concurrent TMZ (daily, 75 mg/m2) and anlotinib (8mg per day, from day 1 to 14, every 3 weeks). After a 4-week break, adjuvant therapy including 6 cycles of TMZ (150–200 mg/m², from day 1 to 5, every 4 weeks) and 8 cycles of anlotinib (8mg per day, from day 1 to 14, every 3 weeks) was given. For patients completing adjuvant therapy, anlotinib alone (8mg per day, from day 1 to 14, every 3 weeks) was administrated until disease progression. RESULTS All patients completed concurrent chemo-radiotherapy without interruption. One patient developed grade 3 weight loss at 56th week and grade 3 presumed radiation-induced cognitive disturbance at 60th week. Fatigue and hypertension were frequently observed during treatment, which potentially be related to the treatment. No severe toxicity was observed in other patients. Up to this writing, none of these patients developed disease progression. CONCLUSION Anlotinib combined with the STUPP regimen is a potential choice for newly diagnosed GBM patients. It is well tolerated and the toxicity is manageable. It’s acceptable to continue enrolling of this Phase II study.

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