CINXE.COM

<!DOCTYPE html><html lang="en" class="h-100"><head><meta charset="utf-8"><meta http-equiv="X-UA-Compatible" content="IE=edge"><meta name="viewport" content="width=device-width, initial-scale=1, shrink-to-fit=no"><title> UCSF Neuroblastoma Trial → Pediatric Precision Laboratory Advanced Neuroblastoma Therapy</title><meta property="og:title" content="UCSF Neuroblastoma Trial: Pediatric Precision Laboratory Advanced Neuroblastoma Therapy"><meta name="description" content="This Neuroblastoma study at UCSF is now recruiting people ages up to 22 years."><meta property="og:description" content="This Neuroblastoma study at UCSF is now recruiting people ages up to 22 years."><meta property="og:url" content="https://clinicaltrials.ucsf.edu/trial/NCT02559778"><link rel="canonical" href="https://clinicaltrials.ucsf.edu/trial/NCT02559778"><meta name="author" content="UCSF"><meta name="generator" content="edu.ucsf.ctsi.rt.trialfinder"><meta name="referrer" content="origin-when-cross-origin"><meta name="google-site-verification" content="JXe923j97sTSgp-6yxsCdd25Muv0wMNfDR27ba3ER8M"><meta name="msvalidate.01" content="4E5209CC6688B86BBDD2FE074176C029"><link rel="shortcut icon" href="https://clinicaltrials.ucsf.edu/assets/local/ucsf/img/favicon.png"><link rel="alternate" type="application/atom+xml" title="UCSF Clinical Trials" href="https://clinicaltrials.ucsf.edu/meta/feed.atom"><meta property="og:type" content="website"><meta name="twitter:card" content="summary"><meta name="twitter:site" content="@ucsf"><meta property="og:image" content="https://clinicaltrials.ucsf.edu/assets/local/ucsf/img/share-image.jpg"><link rel="stylesheet" href="https://clinicaltrials.ucsf.edu/assets/local/ucsf/ucsf_identity/banners.css"> <link rel="stylesheet" href="https://cdn.jsdelivr.net/npm/bootstrap@4.4.1/dist/css/bootstrap.min.css" integrity="sha256-L/W5Wfqfa0sdBNIKN9cG6QA5F2qx4qICmU2VgLruv9Y=" crossorigin="anonymous"><link rel="stylesheet" href="https://cdn.jsdelivr.net/gh/coliff/bootstrap-rfs@4.3.1/bootstrap-rfs.css" media="screen and (max-width: 1200px)" integrity="sha256-DgOE2c1ekD0TaTyiCQuH2NdeiZ6VifYJdLdfDwq6C+U=" crossorigin="anonymous"><link rel="stylesheet" href="https://cdn.jsdelivr.net/npm/animate.css@3.7.2/animate.min.css" integrity="sha256-PHcOkPmOshsMBC+vtJdVr5Mwb7r0LkSVJPlPrp/IMpU=" crossorigin="anonymous"><link rel="stylesheet" href="https://cdn.jsdelivr.net/npm/font-awesome@4.7.0/css/font-awesome.min.css" integrity="sha256-eZrrJcwDc/3uDhsdt61sL2oOBY362qM3lon1gyExkL0=" crossorigin="anonymous"><link rel="stylesheet" href="https://clinicaltrials.ucsf.edu/assets/css/style.css"><link rel="stylesheet" href="https://clinicaltrials.ucsf.edu/assets/local/ucsf/css/style-local.css"> <script src="https://polyfill-fastly.io/v3/polyfill.min.js?features=default%2CObject.assign%2CObject.entries%2CPromise%2CURLSearchParams%2CURL" crossorigin="anonymous" defer></script> <script src="https://cdn.jsdelivr.net/jquery/2.2.4/jquery.min.js" integrity="sha256-BbhdlvQf/xTY9gja0Dq3HiwQF8LaCRTXxZKRutelT44=" crossorigin="anonymous" defer></script><script src="https://cdn.jsdelivr.net/npm/bootstrap@4.4.1/dist/js/bootstrap.bundle.min.js" integrity="sha256-OUFW7hFO0/r5aEGTQOz9F/aXQOt+TwqI1Z4fbVvww04=" crossorigin="anonymous" defer></script><script src="https://cdn.jsdelivr.net/npm/readmore-js@2.2.1/readmore.min.js" integrity="sha256-ygz7RPJkJA9GMkV/1XKiK5GEfenXOdkEj2yhi8LRipU=" crossorigin="anonymous" defer></script> <script src="https://cdn.jsdelivr.net/jquery.validation/1.15.1/jquery.validate.min.js" integrity="sha256-uUVS/d3xM3l8YmucAkj1DeRt6U4Y+Xv3ePUgVVEVmVw=" crossorigin="anonymous" defer></script><script src="https://cdn.jsdelivr.net/npm/mailcheck@1.1.1/src/mailcheck.min.js" integrity="sha256-aAPNEz/OtzaNXAt4jf5P9xxwG8GvJ5owTS5BtGMELGs=" crossorigin="anonymous" defer></script><script src="https://www.google.com/recaptcha/api.js" defer></script> <script src="https://clinicaltrials.ucsf.edu/assets/js/app.js" defer></script><script>var google_analytics_live_mode=0;var google_analytics_id='UA-1142388-28';var google_analytics_hostname='clinicaltrials.ucsf.edu';if(google_analytics_id&&google_analytics_hostname&&window.location&&window.location.hostname&&window.location.hostname===google_analytics_hostname){google_analytics_live_mode=1}var google_analytics_js_url='https://www.google-analytics.com/analytics_debug.js';if(google_analytics_live_mode){google_analytics_js_url='https://www.google-analytics.com/analytics.js'}(function(c,h,e,b,f,a,d){c['GoogleAnalyticsObject']=f;c[f]=c[f]||function(){(c[f].q=c[f].q||[]).push(arguments)},c[f].l=1*new Date();a=h.createElement(e),d=h.getElementsByTagName(e)[0];a.async=1;a.src=b;d.parentNode.insertBefore(a,d)})(window,document,'script',google_analytics_js_url,'ga');if(!google_analytics_live_mode){}if(google_analytics_live_mode){ga('create',google_analytics_id,'auto')}else{ga('set','sendHitTask',null)}ga('require','outboundLinkTracker');ga('require','pageVisibilityTracker');ga('send','pageview');var s_opt={};s_opt['s_apid']='53G5XLK75T';s_opt['s_ixnm']='trials_ucsf';s_opt['s_ixky']='6e038166fd15da69c2ed075975c00816';s_opt['s_plac']=undefined;s_opt['s_mlti']=false;var _paq=window._paq=window._paq||[];_paq.push(['setTrackerUrl','https://clinicaltrials.ucsf.edu/action/t/l/']);_paq.push(['setSiteId','9']);_paq.push(['setCustomDimension',1,'trial\u002dpage']);_paq.push(['trackPageView']);_paq.push(['enableLinkTracking']);_paq.push(['enableHeartBeatTimer']);(function(){var a=document,g=a.createElement('script'),s=a.getElementsByTagName('script')[0];g.type='text/javascript';g.async=true;g.src='https://clinicaltrials.ucsf.edu/action/t/js/';s.parentNode.insertBefore(g,s)})();</script><script async src="https://cdn.jsdelivr.net/npm/autotrack@1.0.3/autotrack.js" integrity="sha256-MFv0PQKCj7HPlACiJTgQ+3rHnOSY1a510jcQGGwtemQ=" crossorigin="anonymous"></script><script type="application/ld+json"> { "@context": "https://schema.org/", "@type": "WebSite", "publisher": { "@type": "MedicalOrganization", "name": "UCSF", "address": "San Francisco Bay Area", "url": "https://www.ucsf.edu/", "logo": "https://s2.googleusercontent.com/s2/favicons?domain_url=https%3A%2F%2Fwww.ucsf.edu%2F", "sameAs": [ "https://twitter.com/@ucsf" ] } } </script><meta name="ahrefs-site-verification" content="5f73483e1fea16c76799e8797bf1b843c1c0cda17921ee5e1670f98bd81223f4"></head><body class="trial-page bg-light d-flex flex-column"> <a id="skip-to-main-content" class="sr-only sr-only-focusable" href="#content">Skip to main content</a> <header id="header" class="mb-4"><div id="ucsf-banner-nav"><div class="container-fluid"><div class="top-header-container" style="max-width: 100%"><div><ul class="menu"><li class="first"><a href="https://www.ucsf.edu">University of California San Francisco</a></li><li><a href="https://www.ucsfhealth.org/">UCSF Medical Center</a></li><li><a href="https://www.ucsf.edu/search">Search UCSF</a></li><li><a href="https://www.ucsf.edu/about">About UCSF</a></li></ul></div></div></div></div><nav class="navbar navbar-expand-md navbar-light d-print"> <a class="navbar-brand" href="https://clinicaltrials.ucsf.edu/"> <img src="https://clinicaltrials.ucsf.edu/assets/local/ucsf/img/site-name.png" alt="UCSF Clinical Trials"> </a> <button class="navbar-toggler" type="button" data-toggle="collapse" data-target="#navbar--menu--primary-content" aria-controls="navbar--menu--primary-content" aria-expanded="false" aria-label="Toggle navigation"> <span class="navbar-toggler-icon"></span> </button> <div class="collapse navbar-collapse justify-content-end" id="navbar--menu--primary-content"><ul class="navbar-nav"> <li class="nav-item" id="navbar--menu--home"> <a class="nav-link" href="https://clinicaltrials.ucsf.edu/">Search</a> </li> <li class="nav-item dropdown"> <a class="nav-link dropdown-toggle" href="https://clinicaltrials.ucsf.edu/browse/" id="navbar--menu--browse-dropdown-link" role="button" data-toggle="dropdown" aria-haspopup="true" aria-expanded="false"> Browse </a> <div class="dropdown-menu dropdown-menu-right" aria-labelledby="navbar--menu--browse-dropdown-link"> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/">All trials</a> <div class="dropdown-divider"></div><div class="dropdown-header">Trials for…</div> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/healthy">Healthy volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/pediatric" title="Pediatric clinical trials, for people under age 18">People under 18</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/geriatric" title="Geriatric clinical trials, for people over age 65">People over 65</a> <div class="dropdown-divider"></div><div class="dropdown-header">Trials seeking…</div> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/black" title="Trials that may be particularly relevant to Black volunteers"> Black volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/chinese" title="Trials that may be particularly relevant to Chinese volunteers"> Chinese volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/hmong" title="Trials that may be particularly relevant to Hmong volunteers"> Hmong volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/korean" title="Trials that may be particularly relevant to Korean volunteers"> Korean volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/latinx" title="Trials that may be particularly relevant to Latinx volunteers"> Latinx volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/lgbtqia" title="Trials that may be particularly relevant to LGBTQIA+ volunteers"> LGBTQIA+ volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/mena" title="Trials that may be particularly relevant to Middle Eastern or North African volunteers"> Middle Eastern or North African volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/native-hawaiian" title="Trials that may be particularly relevant to Native Hawaiian volunteers"> Native Hawaiian volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/south-asian" title="Trials that may be particularly relevant to South Asian volunteers"> South Asian volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/veteran" title="Trials that may be particularly relevant to Veteran volunteers"> Veteran volunteers</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/browse/vietnamese" title="Trials that may be particularly relevant to Vietnamese volunteers"> Vietnamese volunteers</a> </div></li> <li class="nav-item" id="navbar--menu--equity" data-nosnippet> <a class="nav-link" href="https://clinicaltrials.ucsf.edu/about/equity">Equity <span class="d-none d-xl-inline">in Research</span></a></a> </li> <li class="nav-item dropdown"> <a class="nav-link dropdown-toggle" href="https://clinicaltrials.ucsf.edu/about/" id="navbar--menu--about-dropdown-link" role="button" data-toggle="dropdown" aria-haspopup="true" aria-expanded="false"> About <span class="d-none d-lg-inline">the site</span> </a> <div class="dropdown-menu dropdown-menu-right" aria-labelledby="navbar--menu--about-dropdown-link"> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/about/">About UCSF Clinical Trials</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/about/for-researchers">For Researchers</a> <div class="dropdown-divider"></div><div class="dropdown-header">Learn more in…</div> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/about/chinese" data-nosnippet>Chinese</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/about/spanish" data-nosnippet>Spanish</a> <a class="dropdown-item" href="https://clinicaltrials.ucsf.edu/about/vietnamese" data-nosnippet>Vietnamese</a> </div></li></ul></div> </nav><nav class="breadcrumb-and-search-bar navbar navbar-expand navbar-light d-print d-flex justify-content-between"> <div><ol class="breadcrumb navbar-text my-0 pl-1" itemscope="itemscope" itemtype="https://schema.org/BreadcrumbList"><li itemprop="itemListElement" itemscope itemtype="https://schema.org/ListItem"> <a href="https://clinicaltrials.ucsf.edu/" itemscope="itemscope" itemprop="item" itemtype="https://schema.org/Thing" id="navbar--breadcrumb--link-1"> Home <meta itemprop="name" content="UCSF Clinical Trials"> </a> <meta itemprop="position" content="1"></li><li itemprop="itemListElement" itemscope itemtype="https://schema.org/ListItem"> <a href="https://clinicaltrials.ucsf.edu/neuroblastoma" itemscope="itemscope" itemprop="item" itemtype="https://schema.org/Thing" aria-description="See all trials related to Neuroblastoma" id="navbar--breadcrumb--link-2"> <span itemprop="name">Neuroblastoma</span> Studies </a> <meta itemprop="position" content="2"></li><li class="active">This trial</li></ol></div> <div><div class="d-none d-md-block navbar-text"><form method="GET" action="https://clinicaltrials.ucsf.edu/" class="form-inline my-1" role="search"> <label class="sr-only" for="header-search--input">Search</label> <input id="header-search--input" name="q" type="text" class="form-control form-control-sm" placeholder="Search UCSF clinical trials" title="Search clinical trials at UCSF"> <input class="sr-only form-control-sm btn btn-sm btn-secondary" type="submit" value="Search trials"> </form></div></div> </nav></header><main id="content" class="mx-1 mx-md-0"> <div class="container-xl px-5"><div class="row"><div class="col-md-9 col-lg-8" role="main" id="main-column"><div id="summary" class="page-header show-jargon-definitions"><h1 id="summary--title"> Pediatric Precision Laboratory Advanced Neuroblastoma Therapy </h1><p class="h3 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../neuroblastoma">Neuroblastoma</a></span></span></p></div><div id="trial-details-container"><div id="key-points" class="trial-details-block"><div class="row"> <div class="col"><h2 class="sr-only h3">Summary</h2><dl id="key-points-bullets" class="row"><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Eligibility</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>for people ages up to 22 years</strong> (<a href="#eligibility">full criteria</a>) </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-map-marker fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Location</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <a href="#location"> at Oakland, California and other locations </a> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-calendar fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Dates</span></dt><dd class="col-12 col-sm-11 col-lg-10"><div> study started <span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateCreated" datetime="2015-09-01">September 2015</time></span></div><div> completion around <time datetime="2035-09-30">September 2035</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2015-09-24"></div></dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user-md fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Principal Investigator</span></dt><dd class="col-12 col-sm-11 col-lg-10 comma-list"> by <span class="pi-name comma-list-item"><span><a href="https://profiles.ucsf.edu/jennifer.michlitsch" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Jennifer Michlitsch, MD</a></span></span></dd></dl></div> <div class="d-none d-md-block col-md-auto" id="pi-photos-block"><figure class="figure"><img class="pi-photo figure-img img-fluid rounded" src="https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=33508935" alt="Headshot of Jennifer Michlitsch" loading="lazy"><figcaption class="figure-caption">Jennifer Michlitsch</figcaption></figure></div></div></div><div id="description" class="trial-details-block"><h2 class="h3">Description</h2><div class="show-jargon-definitions"><h3 class="h4">Summary</h3><div class="hide-long-content"><p>A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard <a href="../immunotherapy" class="trial--link-to-condition-in-text">immunotherapy</a> with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk <a href="../neuroblastoma" class="trial--link-to-condition-in-text">Neuroblastoma</a>.</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma</p><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> <a href="../neuroblastoma" class="trial--link-to-condition-in-text">Neuroblastoma</a></span>, <span> Eflornithine</span>, <span> Sorafenib</span>, <span> Dasatinib</span>, <span> Vorinostat</span>, <span> Ceritinib</span>, <span> DFMO</span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><p><strong>For people ages up to 22 years</strong></p><p>Part A- CLOSED:</p><ol><li><p>Diagnosis: Subjects must have a diagnosis of neuroblastoma or <a href="../ganglioneuroblastoma" class="trial--link-to-condition-in-text">ganglioneuroblastoma</a> (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites. Subjects with the following disease stages at diagnosis are eligible, if they meet the other specified criteria:</p><p> a) Subjects with newly diagnosed neuroblastoma with INSS Stage 4 are eligible with the following: i. Age > 18 months (> 547 days) regardless of biologic features or ii. Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index = 1) or iii. MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features.</p><p> b) Subjects with newly diagnosed neuroblastoma with INSS Stage 3 are eligible with the following: i. MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features or ii. Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN status.</p><p> c) Subjects with newly diagnosed neuroblastoma with INSS Stage 2A/2B with MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features.</p></li><li>Subjects must be age ≤ 21 years at initial diagnosis</li><li>Subjects must not have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (as per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification status and histology.</li><li>Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.</li><li><p>Ability to tolerate PBSC collection: No known contraindication to PBSC collection. Examples of contraindications would include a weight or size less than that determined to be feasible at the collecting institution, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure.</p><p> Part A and B both- Part A CLOSED, Part B- OPEN:</p></li><li>Adequate Cardiac Function Defined As: <ol><li>Shortening fraction of ≥ 27% by echocardiogram, or</li><li>Ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram.</li></ol></li><li>Adequate liver function must be demonstrated, defined as: <ol type="a"><li>Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND d. ALT (SGPT) < 10 x upper limit of normal (ULN) for age</li></ol></li><li><p>Subjects must have adequate renal function defined as a serum creatinine based on age/gender as follows:</p><p> Age Maximum Serum Creatinine (mg/dL) Male Female 1 month to < 6 months 0.4 0.4 6 months to < 1 year 0.5 0.5 1 to < 2 years 0.6 0.6 2 to < 6 year 0.8 0.8 6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4</p><p> ≥ 16 years 1.7 1.4</p></li><li>A negative serum <a href="../pregnancy" class="trial--link-to-condition-in-text">pregnancy</a> test is required for female participants of child bearing potential (≥13 years of age or after onset of menses)</li><li>Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.</li><li><p>Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.</p><p> Part B- OPEN:</p></li><li>All patients must have a pathologically confirmed diagnosis of neuroblastoma, be age ≤ 21 years at initial diagnosis, and classified as high risk by the criteria used by COG or SIOPEN at the time of diagnosis. Exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible.</li><li>Previous Therapy- subjects must fit into one of the strata categories listed in section 10.5 to be eligible to enroll on Part B of this study.</li><li><p>Pre-enrollment tumor survey:</p><p>Prior to enrollment on Part B, a determination of mandatory disease staging must be performed. Tumor imaging studies including CT or MRI, MIBG or PET, and VMA/HVA (PET scan should be done for patients with prior disease that was MIBG non-avid). Bone marrow aspirates and biopsies are required.</p><p> This disease assessment is required for eligibility and should be done preferably within 2 weeks, but must be done within a maximum of 4 weeks before first dose of study drug.</p></li><li>Timing- Enrollment to occur prior to Day + 120 post-transplant, preferably when the subject is within 28 days after completing local radiation therapy (if given).</li></ol><p>Exclusion Criteria (Part A and B)</p><ol><li>Subjects who are 12-18 months of age with INSS Stage 4 and all stage 3 subjects with favorable biologic features (ie, nonamplified MYCN, favorable pathology, and DNA index > 1) are not eligible.</li><li>Lactating females are not eligible unless they have agreed not to breastfeed their infants.</li><li>Subjects receiving any investigational drug concurrently.</li><li>Subjects with any other medical condition, including but not limited to malabsorption syndromes, <a href="../mental-illness" class="trial--link-to-condition-in-text">mental illness</a> or <a href="../substance-abuse" class="trial--link-to-condition-in-text">substance abuse</a>, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study</li></ol></div></div><div id="location" class="trial-details-block"><h2 class="h3">Locations</h2><ul id="locations-list" class="hide-long-content "><li class="location location-is-institutional" itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">UCSF Benioff Children's Hospital Oakland-</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Oakland</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Rady Children's Hospital</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Diego</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 92123</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li></ul></div><div id="pis" class="trial-details-block"><h2 class="h3">Lead Scientist <span class="d-none d-sm-inline">at UCSF</span></h2><ul class="pis-list--only-one-pi"><li class="pi"><span class="pi-name"> <strong> <a href="https://profiles.ucsf.edu/jennifer.michlitsch" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Jennifer Michlitsch, MD</a> </strong> </span><br> Professor, Pediatrics, School of Medicine. Authored (or co-authored) 23 research publications </li></ul></div><div id="details" class="trial-details-block"><h2 class="h3">Details</h2><dl class="row"><dt class="col-sm-3 text-sm-right">Status</dt><dd class="col-sm-9"> accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2015-09-01">September 2015</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2035-09-30">September 2035</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Giselle Sholler</dd><dt class="col-sm-3 text-sm-right">Links</dt><dd class="col-sm-9"> <a href="http://beatcc.org/" class="trial--link-to-external-study-link d-block" target="_blank" rel="noopener ugc nofollow"><i class="fa fa-link" aria-hidden="true"></i> Beat Childhood Cancer Main Website</a> </dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/ct2/show/NCT02559778" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT02559778</a> </dd><dt class="col-sm-3 text-sm-right">Phase</dt><dd class="col-sm-9">Phase 2 Neuroblastoma Research Study</dd><dt class="col-sm-3 text-sm-right">Study Type</dt><dd class="col-sm-9">Interventional</dd><dt class="col-sm-3 text-sm-right">Participants</dt><dd class="col-sm-9">Expecting 500 study participants</dd><dt class="col-sm-3 text-sm-right">Last Updated</dt><dd class="col-sm-9"><span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateModified" datetime="2024-08-21">August 21, 2024</time></span></dd></dl></div><div id="faq" class="trial-details-block d-print-none" role="complementary"><h2 class="h3">Frequently Asked Questions</h2><ul><li><a href="../about/how-clinical-trials-work">How Do Clinical Trials Work?</a></li><li><a href="../about/what-to-expect">What to Expect</a></li><li><a href="../about/who-can-join">Who Can Join</a></li><li><a href="../about/our-researchers">Our Researchers</a></li></ul></div><div class="text-center my-3"> <a href="#" id="contact-button-end" class="btn btn-primary btn-lg d-none d-md-inline" data-toggle="modal" data-target="#contact-modal" aria-description="Are you interested? Contact us to learn more about joining this clinical trial"> <i class="fa fa-envelope mr-2" aria-hidden="true"></i> Contact us about this trial </a> </div></div> </div><div class="col-md-3 text-center offset-lg-1 d-none d-md-block d-print-none" id="secondary-column"> <div id="sidebar"> <a href="#" id="contact-button-sidebar" class="animated zoomIn btn btn-lg btn-block btn-primary mb-4" data-toggle="modal" data-target="#contact-modal" aria-description="Are you interested? Contact us to learn more about joining this clinical trial"> <span id="contact-button-sidebar--main-text" class="responsive-headline"> I’m interested<span class="d-none d-lg-inline">!</span></span> </a> <aside id="share-links"><h3 class="sr-only">Share study</h3><ul class="list-unstyled"><li class="hide-unless-mobile"> <a id="share-links--email" href="#" role="button" title="Share this trial by email" rel="nofollow"><i class="fa fa-envelope fa-2x" aria-hidden="true"><span class="sr-only">Share by email</span></i></a> </li><li> <a id="print-button-sidebar" href="#" role="button" title="Print this trial for my doctor" rel="nofollow"><i class="fa fa-print fa-2x" aria-hidden="true"><span class="sr-only">Print this trial</span></i></a> </li></ul></aside></div> </div></div> </div> <div id="contact-button-bottom-container" class="d-md-none d-print-none"> <a href="#" id="contact-button-bottom" class="animated fadeInDownBig btn btn-lg btn-block btn-primary d-print-none" data-toggle="modal" data-target="#contact-modal" aria-label="Are you interested? Contact us to learn more about joining this clinical trial"> I’m interested in this study! </a> </div> <div class="modal fade" id="contact-modal" tabindex="-1" role="dialog" aria-labelledby="contact-modal-label" aria-hidden="true"><div class="modal-dialog modal-dialog-scrollable" role="document"><div class="modal-content"><div class="modal-header"><h4 class="modal-title h5" id="contact-modal-label">Please contact me about this study</h4> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true">×</span> </button> </div><div class="modal-body"> <form id="contact-form" class="form-horizontal" action="https://clinicaltrials.ucsf.edu/action/trial-contact/" method="POST"> <input type="hidden" name="Trial_NCT" value="NCT02559778"> <input type="hidden" name="Trial_Title" value="Pediatric Precision Laboratory Advanced Neuroblastoma Therapy"> <input type="hidden" name="Trial_Contact" value="53616c7465645f5f0a141e28323c46502fa6d97aff67141e2008ad1c56925ff7ddacbcd9d68ce7ab3b041f3179f27984"> <div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-name">Name</label> <div class="col-sm-8 form-group--input-container"> <input name="Name" type="text" class="form-control form-control-lg" id="contact-name" placeholder="Your name" required pattern=".*\w\w.*" minlength="2" autocomplete="name"> </div></div><div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-email">Email</label> <div class="col-sm-8 form-group--input-container"> <input name="Email" type="email" class="form-control form-control-lg" id="contact-email" placeholder="Your email" required data-error="Invalid email address" autocomplete="email"> <div id="contact-email--suggestion" class="d-none small"> You typed <span id="contact-email--suggestion-original" class="text-monospace text-info font-weight-bold"></span>. Did you mean <span id="contact-email--suggestion-email" class="text-monospace text-info font-weight-bold"></span>? </div></div></div><div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-phone">Phone</label> <div class="col-sm-8 form-group--input-container"> <input name="Phone" type="tel" class="form-control form-control-lg" id="contact-phone" placeholder="Your phone (optional)" pattern=".*\d.*\d.*\d.*\d.*\d.*\d.*\d.*\d.*" minlength="8" autocomplete="tel"> </div></div><div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right">Are you human?</label> <div class="col-sm-8 form-group--input-container"><div class="g-recaptcha" id="contact-recaptcha-captcha" data-sitekey="6LfpryUTAAAAAKT_A9vSYllUZW9fS3l-SzN_dzU2"></div><p class="small mb-0">This step makes sure spammers don’t flood our inbox</p></div></div><div class="form-group row"><div class="offset-sm-3 col-sm-8"> <button type="submit" class="btn btn-primary btn-lg">Send to study team</button> </div></div></form><p class="small">We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Submitting your contact information does not obligate you to participate in research.</p></div> </div></div></div><div class="modal fade" id="contact-thank-you-modal" tabindex="-1" role="dialog" aria-hidden="true" aria-labelledby="contact-modal-label"><div class="modal-dialog" role="document"><div class="modal-content"><div class="modal-header"> <button type="button" class="close" data-dismiss="modal"><span aria-hidden="true">×</span><span class="sr-only">Close</span></button> <h4 class="modal-title h5" id="contact-thank-you-modal-label">Thank you!</h4></div><div class="modal-body"><p>The study team should get back to you in a few business days.</p><p>You will also receive an email with next steps. Check your junk/spam folder if needed.</p><p>If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02559778.</p></div><div class="modal-footer"> <button type="button" class="btn btn-primary" data-dismiss="modal">OK</button> </div></div></div></div> <script type="application/ld+json"> [{"@context":"https://schema.org/","@type":"MedicalTrial","additionalType":"Product","alternateName":"A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma","code":{"@type":"MedicalCode","codeValue":"NCT02559778","codingSystem":"ClinicalTrials.gov"},"description":"A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma.","healthCondition":[{"@type":"MedicalCondition","name":"Neuroblastoma"}],"name":"Pediatric Precision Laboratory Advanced Neuroblastoma Therapy","sameAs":"https://clinicaltrials.gov/study/NCT02559778","sponsor":[{"@type":"Organization","name":"Giselle Sholler"},{"@context":"https://schema.org/","@type":"Person","affiliation":{"@type":"Organization","name":"UCSF"},"description":"Professor, Pediatrics, School of Medicine. Authored (or co-authored) 23 research publications","image":"https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=33508935","isicV4":"7210","jobTitle":"Principal Investigator","name":"Jennifer Michlitsch","url":"https://profiles.ucsf.edu/jennifer.michlitsch"}],"status":"https://schema.org/Recruiting","studyLocation":[{"@type":"AdministrativeArea","address":{"@type":"PostalAddress","addressCountry":"United States","addressLocality":"Oakland","addressRegion":"California"},"name":"UCSF Benioff Children's Hospital Oakland-"}],"studySubject":[{"@type":"MedicalEntity","name":"Neuroblastoma"},{"@type":"MedicalEntity","name":"Eflornithine"},{"@type":"MedicalEntity","name":"Sorafenib"},{"@type":"MedicalEntity","name":"Dasatinib"},{"@type":"MedicalEntity","name":"Vorinostat"},{"@type":"MedicalEntity","name":"Ceritinib"},{"@type":"MedicalEntity","name":"DFMO"}],"trialDesign":["https://schema.org/MultiCenterTrial"]},{"@type":"Offer","availability":"https://schema.org/InStock","availabilityEnds":"2035-09-30","availabilityStarts":"2015-09-01","hasAdultConsideration":[],"name":"Pediatric Precision Laboratory Advanced Neuroblastoma Therapy","price":0,"priceCurrency":"USD","sku":"NCT02559778","validFrom":"2015-09-01","validThrough":"2035-09-30"},{"@context":"https://schema.org/","@type":"Place","address":{"@type":"PostalAddress","addressCountry":"United States","addressLocality":"Oakland","addressRegion":"California"},"name":"UCSF Benioff Children's Hospital Oakland-"},{"@context":"https://schema.org/","@type":"Person","affiliation":{"@type":"Organization","name":"UCSF"},"description":"Professor, Pediatrics, School of Medicine. Authored (or co-authored) 23 research publications","image":"https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=33508935","isicV4":"7210","jobTitle":"Principal Investigator","name":"Jennifer Michlitsch","url":"https://profiles.ucsf.edu/jennifer.michlitsch"}] </script> </main><footer class="mt-auto" role="contentinfo" data-nosnippet><div id="ucsf--footer--body"><div class="container" data-nosnippet><div class="row mb-1 d-print-none"><div class="col-12 text-center text-md-left"> We use cookies to operate our website, analyze performance, and improve your experience on our site. <a href="https://www.ucsf.edu/website-privacy-policy" target="_blank">Learn more.</a> </div></div><div class="row"><div class="col-md-6 text-center text-md-left"><p class="my-0"> © The Regents of the University of California </p></div><div class="col-md-6 text-center text-md-right pt-3 pt-md-0"> <a href="https://websites.ucsf.edu/digital-accessibility" target="_blank">Accessibility</a> <a href="https://www.ucsf.edu/website-privacy-policy" target="_blank">Privacy Policy</a> <a href="https://websites.ucsf.edu/website-terms-use" target="_blank">Terms of Use</a> </div></div></div></div></footer><script>(function(){var b=document.createElement('script');b.type='text/javascript';b.async=true;b.src='//siteimproveanalytics.com/js/siteanalyze_8343.js';var a=document.getElementsByTagName('script')[0];a.parentNode.insertBefore(b,a)})();</script></body></html>