Careers. 1982;38(1):14351. J Nat Cancer Inst. Wu J, Pan H, Hsu CW. Stat Med. Brief Summary: An International, Single-Arm, Multicenter Phase 2 Trial. FOIA 2018;74(2):529-537. Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial Summary Thus, the maximum unacceptable response rates for historical controls should be considered throughout literature examination and/or previous research experience to screen out the inefficacious treatments [47, 48]. 2023 Jan;37(1):45-67. doi: 10.1007/s40263-022-00975-5. Federal government websites often end in .gov or .mil. Since the two-stage design of Phase 2 trials aims to make a conclusion of go or no-go to the next second stage, the sample size calculation of two-stage designs produces the number of patients in first stage (\({n}_{1}\)) and the response number which is eligible to move to the second stage (\({r}_{1}\)). The PFS at 6months (PFS6) is the most widely used endpoint in glioblastoma trials because of reflection of the rate of cases of durable disease control [58]. View this study on Beta.ClinicalTrials.gov, Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. TACE-HAIC Plus Lenvatinib for Patients With Unresectable HCC: an Open-label, Single-arm, Phase 2 Trial (Thalen) The safety and scientific validity of this study The survival endpoint was introduced as Bayesian extension of Simons two-stage design and R package BayesDesign [57]. Glioblastoma (GBM) is the most commonly occurring malignant brain and other CNS tumor in adults in the United States and is the most aggressive brain tumor with less than 10% of patients surviving beyond 5years [4]. The adaptive design allows the incorporation of interim results to adjust the second stage designs under still controlling the Type 1 error rate and may provide economic benefit by reducing the waste of resources (Fig. Adult T-cell leukemia/lymphoma (ATL) is an aggressive non-Hodgkin lymphoma with poor prognosis and few treatment options for patients with relapsed, recurrent, or refractory disease. Rubinstein LV, et al. Phase II and biomarker study of programmed cell death protein 1 inhibitor nivolumab and metronomic cyclophosphamide in paediatric relapsed/refractory solid tumours: Arm G of AcSe-ESMART, a trial of the European innovative therapies for children with cancer consortium. Thus, it can summarize the treatment effect over the whole duration of a trial, not just at a specific time point, so that it provides a comprehensive evaluation within the trial duration. More than three quarter articles (n=22, 76%) provided all related information of type I and II errors (\(\alpha , \beta\)) and unacceptable and acceptable response rates (\({p}_{0}, {p}_{1}\)). Survival gain in glioblastoma patients treated with dendritic cell immunotherapy is associated with increased NK but not CD8(+) T cell activation in the presence of adjuvant temozolomide. Bethesda, MD 20894, Web Policies Exploration of modified progression-free survival as a novel surrogate endpoint for overall survival in immuno-oncology trials. 2020;323(9):84453. 2008;14(12):367582. WebSingle-dose carboplatin followed by involved-node radiotherapy for stage IIA and stage IIB seminoma (SAKK 01/10): a single-arm, multicentre, phase 2 trial Erstverffentlichung 2022 government site. Further investigations are needed to identify which patients with LMD can benefit from pembrolizumab. 2019;37(15_suppl):1820618206. 2022;14(3):28394. In other words, we might encounter the variability in the historical controls for comparison, which substantially inflates the Type 1 error rate or false-positive error rate and may lead to erroneous conclusions. 8600 Rockville Pike Neurosurg. Trippa L, et al. The median PFS of 4.2 months was in the range of phase III trials using the standard 21/28 day pomalidomide schedule (4.04.6 months) [1, 2]. BMJ. Phase II study of Dovitinib in recurrent glioblastoma. Sanai N. Phase 0 clinical trial strategies for the neurosurgical oncologist. Intraventricular methotrexate therapy of leptomeningeal metastasis from breast carcinoma. Privacy Webmultiple myeloma: a multicenter, single-arm phase 2 trial Thilo Zander 1, Thomas Pabst 2, Smi Schr 3, Stefan Aebi 1,2, Ulrich Mey 4, Urban Novak2, Erika Lerch 5, Galle Rhyner Agocs 6, Second, given the limited number of available single-arm two-stage trials, the results in these studies are subject to specific degree of selection criteria. 2016;43(1):138. Please enable it to take advantage of the complete set of features! HHS Vulnerability Disclosure, Help 1R01CA227156-01/U.S. Except for three clinical trials that didnt provide the methods used, almost all articles were Simons two-stage designs (n=23, 90%). Bookshelf The https:// ensures that you are connecting to the Neuro Oncol. A Phase 2 single-arm study using two-stage design [42], where a new treatment option of hypoxia activated evofosfamide (TH302) for patient with recurrent bevacizumab-refractory glioblastoma was investigated. An official website of the United States government. Read our, ClinicalTrials.gov Identifier: NCT04560166, Interventional The percentage of patients who experienced one (or more) grade 3 or higher adverse events at least possibly related to treatment was 40%, the most frequent being hyperglycemia (n = 6), nausea (n = 7) and vomiting (n = 7). If it may be available to enroll only ten patients per year, the optimal design needs a half year longer than the minimax design. This site must represent disease recurrence after completion of therapy, progressive disease on therapy, or refractory disease during induction, Myelodysplastic syndrome or any malignancy other than NB, Any systemic anti-cancer therapy within 3 weeks, Autologous stem cell transplant (ASCT) within 6 weeks prior to enrollment or ongoing toxicity due to the stem cell transplant at the discretion of the investigator, Therapeutic 131I-MIBG within 6 weeks prior to enrollment, Radiotherapy (RT) within 4 weeks prior to enrollment at any lesion site that will be identified as a target lesion to measure tumor response, Prior treatment with anti-GD2 if the patient experienced Progressive Disease (PD) while on anti-GD2 treatment, Receipt of second line chemotherapy after designation of primary refractory disease or first relapse or PD, NB in the Central Nervous System (CNS) or leptomeningeal disease within 6 months prior to enrollment, Performance status of < 50% as per the Lansky scale (patients less than 16 years of age) or Karnofsky scale (for patients aged 16 years or older), Left ventricular ejection fraction < 50% by echocardiography, Treatment with long-acting myeloid growth factor within 14 days or short-acting myeloid growth factor within 7 days prior to first dose of GM-CSF, Receipt of immunosuppressive treatment (local steroids excluded) within 4 weeks prior to enrollment, Uncontrolled seizure disorders despite anticonvulsant therapy (defined as a seizure event within 3 months prior to enrollment), Treatment with enzyme-inducing anticonvulsants including phenytoin, phenobarbital, or carbamazepine for at least 7 days prior to enrollment, Allogeneic hematopoietic stem cell transplantation (allo-SCT) or donor-lymphocyte-infusion (defined as any kind of active allogeneic lymphocyte suspension), Treatment with Hematopoietic Progenitor Cell (HPC) boost within 2 months prior to enrollment, History of allergy or known hypersensitivity to GM-CSF, yeast-derived products, or any component of GM-CSF, naxitamab, irinotecan or temozolomide, History of anaphylactic reactions CTCAE Grade 4 related to prior anti-GD2 antibody therapy, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >5 times upper normal limit (UNL), Unacceptable kidney function at screening, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 calculated by the 2009 revised Bedside Schwartz Equation, Significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of trial agents or to significantly increase the severity of the toxicities experienced from trial treatment, Females of childbearing potential who are pregnant, breast feeding, intend to become pregnant, or are not using adequate contraceptive methods or males who are not using adequate contraceptive methods. Glioblastoma clinical trials: current landscape and opportunities for improvement. Before Careers. Wouters OJ, McKee M, Luyten J. J Neurooncol. Fifty-six of the 70 (80%) participants became desensitized to peanuts. An official website of the United States government. Eltarhoni K, Kamel F, Ihebunezie K, Nisar P, Soloviev M. Int J Mol Sci. JR reports personal fees from Takeda, ADC Therapeutics, Bristol-Myers Squibb, Novartis, Kite Pharma, and Seattle Genetics, and his spouse owns stock in AstraZeneca, outside of the submitted work. Among examined 29 trials, 12 trials (41%) appropriately provided key input parameters and sample size results from two-stage design implementation. Patients received valemetostat 200 mg/day until progressive disease or unacceptable toxicity. Please enable it to take advantage of the complete set of features! 2022 Feb 20;41(4):786-797. doi: 10.1002/sim.9258. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Phase II study of ipilimumab and nivolumab in leptomeningeal carcinomatosis. CC-S reports grants from ADC Therapeutics, during the conduct of the study; and grants from Rhizen Pharmaceuticals, and personal fees from Servier, Novartis, Genenta Science, ADC Therapeutics, Roche, Boehringer Ingelheim, Sanofi, Karyopharm, Bristol-Myers Squibb, Merck Sharp & Dohme, Janssen Oncology, and AstraZeneca, outside of the submitted work. Patients pretreated with mogamulizumab had an ORR of 45.8% (4 complete and 7 partial remissions). WebARTICLE Clinical Trials 2011; 8: 260269 Quantitative evaluation of single-arm versus randomized phase II cancer clinical trials Gregory R Ponda,b and Saqib Abbasia Background There is a debate among cancer researchers about the use of single-arm or randomized phase II clinical trial designs; however, there is limited published statement and WebThis single-arm, phase I trial evaluated NHS-IL12 12 g/kg SC q2w or 16.8g/kg SC q2w in patients with metastatic solid tumors. Disclaimer, National Library of Medicine PMC Leveraging Molecular and Immune-Based Therapies in Leptomeningeal Metastases. The first case is to consider them co-primary endpoints and the other case two primary endpoints. The https:// ensures that you are connecting to the Valemetostat 200 mg orally once Would you like email updates of new search results? eCollection 2020 Dec. BMC Med Res Methodol. Phase II study of sunitinib malate in patients with recurrent high-grade glioma. Epub 2022 Jan 6. Simons two-stage designs have been widely used for single-arm trials in glioblastoma since Simon proposed his landmark paper in 1989 [6], and has been extended with various methodological development like the basket trials [7, 8] and Bayesian approach [9,10,11]. 2013;33(4):165760. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. FOIA Active disease despite previous aggressive multi-drug chemotherapy, defined as one of the following: The patients must have one of the following (locally assessed) obtained within 3 weeks prior to enrollment and at least 10 calendar days after end of any prior anti-cancer treatment: Unacceptable hematological status at screening, defined as one of the following: Unacceptable liver function at screening, defined as one of the following: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Kim and Wong (2022) recently introduced novel designs that compromise on the two optimality criteria using the spatial information on the first stage's required sample size and the total required sample size [52]. P30 CA022453/CA/NCI NIH HHS/United States, R01 GM107639/GM/NIGMS NIH HHS/United States. Bayesian single-arm phase II trial designs with time-to-event endpoints. Springer Nature. It might look reasonable to select the historical controls from previous research studies if the study is homogeneous with the previous studies. Fortunately, several reviews present that PFS6 and OS are generally strongly associated in glioblastoma trials, but not between RR and OS [54]. Future research might include the development of the study design on how we can utilize the phase 0 trials to enhance the success rates in Phase 2 trials in glioblastoma and CNS cancers. Article An armof a clinical trial is a group of patients receiving a specific treatment (or no treatment). Oncol Lett. IEAC-assessed median DOR was not reached (NR; 95% CI, 1.87 months to NR). BSK reports grants from ADC Therapeutics, during the conduct of the study; and personal fees from Seattle Genetics and Genentech, outside of the submitted work. Biometrics. J Clin Oncol. 2020 Aug;26(8):1309. doi: 10.1038/s41591-020-0978-1. WebMethods: We did a multicentre (28 hospital sites in the USA, UK, Italy, and Switzerland), open-label, single-arm, phase 2 trial (LOTIS-2) in patients aged 18 years or older with 2017;8(45):79298304. We study the relationship between a two-stage design with a safety endpoint and an efficacy endpoint and use simulation studies to ascertain their properties. Department of Health & Human Services | NIH | National Cancer Institute (NCI)/International, 5R21CA220253-02/U.S. MeSH Searches were conducted using the electronic database of PubMed, Google Scholar and ClinicalTrials.gov for potentially eligible publications from inception by two independent researchers up to May 26, 2022. However, there are circumstances where the minimax designs are preferrable than the optimal design. 2022;28(4):594602. The https:// ensures that you are connecting to the A common practice in sample size calculation is For instance, Silvani et al. 2022 Dec 9;2022(1):146-154. doi: 10.1182/hematology.2022000332. PMC Safety and efficacy of decitabine in combination with temozolomide in metastatic melanoma: a phase I/II study and pharmacokinetic analysis. Unfortunately, most trials (n=20, 69%) failed to provide the references on the historical control rates. Overly optimistic results obtained from Phase 2 trials might be a major reason of negative Phase 3 results in randomized studies. Phase II trial of an AKT inhibitor (perifosine) for recurrent glioblastoma. If equal to or more than 2 of these patients are progression-free after 4months, the trial continues with additional 22 patients. 2013;10(5):72034. 2022 May;78(5):707-719. doi: 10.1007/s00228-021-03253-3. Randomized prospective comparison of intraventricular methotrexate and thiotepa in patients with previously untreated neoplastic meningitis. 2019;20(2):27386. PMC 2022. Among 29 reviewed articles, majority study types were glioblastoma (n=20, 69% over high-grade glioma, n=9, 31%) with recurrent patients (n=23, 79% over newly diagnosed patients, n=6 and 21%) and adult patients (n=22, 76% over pediatric population, n=7, 24%). Mateos et al. You have reached the maximum number of saved studies (100). Clinical end points in recurrent glioblastoma: are antiangiogenic agents friend or foe? 2015;121(2):297302. Furthermore, only 3 trials (10%) provided appropriate information for key input and output data as well as references information of historical control rates. Invest New Drugs. Correspondence to In this research, we proposed a piecewise proportional hazards cure rate model with random delayed treatment effect to design single-arm phase II immunotherapy cancer trials. Evaluating efficacy and safety of loncastuximab tesirine injection for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. Clin Cancer Res. Clipboard, Search History, and several other advanced features are temporarily unavailable. An increasing fraction of patients with metastatic cancer develop leptomeningeal dissemination of disease (LMD), and survival is dismal1-3. 2001 May;32(2):155-62. doi: 10.1016/s0169-5002(00)00220-8. Cannistra SA. Epub 2021 Oct 17. Evaluation of two-stage designs of Phase 2 single-arm trials in glioblastoma: a systematic review. Kieser M, Rauch G. Two-stage designs for cross-over bioequivalence trials. An interesting novel surrogate endpoint is the post-progress survival (PPS), defined as the duration from the start of a second-line treatment to death. J Neurooncol. Cancer Med. Unable to load your collection due to an error, Unable to load your delegates due to an error. Twenty patients-17 with breast cancer, two with lung cancer and one with ovarian cancer-were enrolled into the pre-specified evaluation group having received at least one dose of pembrolizumab. The choice of type I and type II errors is highly important since researchers need to assure that potentially effective therapy is not abandoned and at the same time the insignificant studies with very small marginal effects should not be advanced to subsequent phase III studies. Stat Med. 2010;28(11):193641. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Irinotecan, solution for infusion (20 mg/mL), Temozolomide, capsules (5 mg, 20 mg and 100 mg), The humanized immunoglobulin isotype G (IgG1) monoclonal antibody (mAb) naxitamab, solution for infusion (4 mg/mL), Sargramostim (GM-CSF), lyophilized 250 g single use vial (250 g/vial), Overall response rate (ORR) [TimeFrame:84 days], ORR after 2 cycles [TimeFrame:42 days], Duration of response (DoR) [TimeFrame:2 years], Complete response (CR) rate [TimeFrame:84 days], Time to first subsequent therapy [TimeFrame:3 years], Progression free survival (PFS) [TimeFrame:3 years], Overall survival (OS) [TimeFrame:3 years], Overall survival (OS) [TimeFrame:1 year], Overall survival (OS) at 2 years [TimeFrame:2 year], Receipt of Standard of Care (SoC) frontline induction/consolidation therapy (including surgery, chemotherapy, ASCT, MIBG, radiotherapy, immunotherapy, or retinoids), verified first progression during multi-drug frontline treatment or, verified first episode of relapse, defined as recurrence after response to frontline treatment, or, verified first designation of refractory disease, defined as persistent metastatic disease (SD or minor response by INRC and MIBG curie score 3) detected at conclusion of at least 4 cycles of multi-drug induction chemotherapy on or according to a high-risk NB treatment protocol as defined above, Measurable tumor on CT/MRI scan that is MIBG-avid or demonstrates increased FDG uptake on PET scan, MIBG (Metaiodobenzylguanidine) scan with positive uptake at a minimum of one site. Second, if we have the stronger interim results of higher activity than assumed in the planning stage, final results may be over-powered without adjusting the sample size [59]. Brenner AJ, et al. The systematic review was performed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA)-statement. Clin Cancer Res. In the classical approach, further 22 patients should be recruited for the second stage although only 3 (13.6%) further patients without progression after 4months are required to demonstrate efficacy. Epub 2019 Nov 4. The outcomes of simulation are depicted in Fig. WA reports grants from Nurix Therapeutics, and personal fees from ADC Therapeutics, Nurix, and Kymera, outside of the submitted work. Compressing drug development timelines in oncology using phase 0 trials. 2022;169:107420. 11, 561569 (1993). Simons two-stage designs include optimal and minimax design [6], while other two-stage designs include Fleming, Gehan, admissible two-stage design [15,16,17]. Phase II trial of triple tyrosine kinase receptor inhibitor nintedanib in recurrent high-grade gliomas. Yoo, W., Kim, S., Garcia, M. et al. 2021 Dec;21(12):1313-1320. doi: 10.1080/14737140.2021.1988853. Results. Nat Commun. Berry SM, et al. Diagnosis and treatment patterns for patients with leptomeningeal metastasis from solid tumors across Europe. Simon R. Optimal two-stage designs for phase II clinical trials. J Neurooncol. Pharm Stat. Jung SH, et al. FOIA The choice of type I and II errors should be considered under overall design framework because the values of two errors affect the sample size, the quality of the study as well as the study budget resources. Admissible two-stage designs for phase II cancer clinical trials. Re-formulating Gehan's design as a flexible two-stage single-arm trial. Epub 2017 May 24. 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Studies ( 100 ) to take advantage of the complete set of features metastatic cancer develop leptomeningeal dissemination disease. Single-Arm trial:45-67. doi: 10.1007/s00228-021-03253-3 leptomeningeal dissemination of disease ( LMD ), and Kymera, outside the... A study is homogeneous with the previous studies PMC safety and efficacy of decitabine in combination temozolomide.: 10.1080/14737140.2021.1988853 leptomeningeal carcinomatosis a safety endpoint and use simulation studies to ascertain their properties of these patients progression-free! Registration or results information appropriately provided key input parameters and sample size results from two-stage design implementation input and! ( 00 ) 00220-8 for the neurosurgical oncologist safety of loncastuximab tesirine injection for the neurosurgical oncologist adult! 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