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id="header-search--input" name="q" type="text" class="form-control form-control-sm" placeholder="Search University of California Health clinical trials" title="Search clinical trials at University of California Health"> <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"><div class="h3 alert alert-danger text-center">This study is in progress, not accepting new patients</div><h1 id="summary--title"> PVSRIPO in Recurrent Malignant Glioma </h1><p class="h3 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../glioma">Glioma</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 18 years and up</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"><span class="comma-list">at <span class="comma-list-item"> UCSF</span></span></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="2017-06-01">June 2017</time></span></div><div> completion around <time datetime="2024-03-31">March 2024</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2016-12-08"></div></dd></dl></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>This is a phase 2 study of oncolytic polio/rhinovirus recombinant (PVSRIPO) in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma.</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">A Multicenter Phase 2 Study of Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) in Recurrent WHO Grade IV Malignant Glioma Patients</p><h3 class="h4">Details</h3><div class="hide-long-content"><p>This is a Phase 2 study of oncolytic polio/rhinovirus recombinant (PVSRIPO) in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma. The objective of this study is to investigate the safety and efficacy (anti-tumor response and survival) of PVSRIPO in recurrent WHO grade IV malignant glioma.</p><p>Patients will be administered PVSRIPO intratumorally via convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. Retreatment with PVSRIPO is allowed, provided retreatment eligibility criteria are met.</p><p>All patients who receive PVSRIPO treatment will be included in efficacy and safety analyses.</p></div><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> Malignant Glioma</span>, <span> <a href="../glioblastoma" class="trial--link-to-condition-in-text">Glioblastoma</a></span>, <span> Glioma</span>, <span> PVSRIPO</span>, <span> Duke</span>, <span> Pro00077024</span>, <span> <a href="../brain-tumor" class="trial--link-to-condition-in-text">Brain tumor</a></span>, <span> Istari</span>, <span> Recurrent</span>, <span> GBM</span>, <span> rGBM</span>, <span> Polio/Rhinovirus Recombinant (PVSRIPO)</span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><div class="row"><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-check-square-o" aria-hidden="true"></i> You can join if… </h3><div><p><strong>Open to people ages 18 years and up</strong></p><p>SUMMARY:</p><ol><li>Patients must have a recurrent (first or second recurrence only, including this recurrence; transformation from a lower grade tumor to a WHO grade IV malignant glioma will be considered a first recurrence) supratentorial WHO grade IV malignant glioma based on <a href="../imaging" class="trial--link-to-condition-in-text">imaging</a> studies with measurable disease (a minimum measurement of 1 cm and maximum of 5.5 cm of contrast-enhancing tumor) with prior histopathology consistent with a WHO grade IV malignant glioma confirmed by the site's neuropathologist or the neuropathologist's designate.</li><li>Male patients who are sexually active are eligible if he and/or his partner(s) meets the criteria outlined in the protocol. Female subjects are eligible if he and/or his partner(s) meets the criteria outlined in the protocol.</li><li>Age ≥ 18 years of age.</li><li>Karnofsky Performance Status (KPS) Score ≥ 70%.</li><li>Prothrombin and Partial Thromboplastin Times ≤ 1.2 x normal prior to biopsy.</li><li>Total bilirubin, serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), alkaline phosphatase ≤ 2.5 x normal prior to biopsy.</li><li>Neutrophil count ≥ 1000 prior to biopsy.</li><li>Hemoglobin ≥ 9 prior to biopsy.</li><li>Platelet count ≥ 100,000/μL unsupported is necessary for eligibility on study; however, because of risks of <a href="../intracranial-hemorrhage" class="trial--link-to-condition-in-text">intracranial hemorrhage</a> with catheter placement, platelet count ≥ 125,000/μL is required for the patient to undergo biopsy and catheter insertion, which can be attained with the help of platelet transfusion.</li><li>Creatinine ≤ 1.2 x normal range prior to biopsy.</li><li>Positive serum anti-PV titer prior to biopsy.</li><li>The patient must have received a boost immunization with trivalent inactivated IPOL™ (Sanofi-Pasteur) at least 1 week, but less than 6 weeks, prior to administration of the study agent.</li><li>At the time of biopsy, prior to administration of virus, the presence of <a href="../recurrent-tumor" class="trial--link-to-condition-in-text">recurrent tumor</a> must be confirmed by histopathological analysis.</li><li>A signed IRB-approve informed consent form (ICF).</li><li>Able to undergo brain MRI with and without contrast.</li></ol></div></div><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-ban" aria-hidden="true"></i> You CAN'T join if... </h3><div><p>SUMMARY:</p><ol><li>Females who are pregnant or <a href="../breastfeeding" class="trial--link-to-condition-in-text">breast-feeding</a>.</li><li>Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons, their designate, and the reviewer designated by the sponsor.</li><li>Patients with severe, active co-morbidity, defined as in the protocol.</li><li>Patients with a previous history of neurological complications due to PV infection.</li><li>Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used.</li><li>Patients may not have received tumor treating fields (≤ 1 week), chemotherapy or bevacizumab ≤ 4 weeks [except for nitrosourea and lomustine (≤ 6 weeks); metronomic dosed chemotherapy, such as daily temozolomide, etoposide or cyclophosphamide (≤ 1 week)] prior to starting the study drug.</li><li>Patients may not have received <a href="../immunotherapy" class="trial--link-to-condition-in-text">immunotherapy</a> ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy.</li><li>Patients may not be less than 12 weeks from radiation therapy of the brain, unless <a href="../progressive-disease" class="trial--link-to-condition-in-text">progressive disease</a> outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation.</li><li>Prior to enrollment, has not completed all standard of care treatments, including surgical procedure and radiation therapy (at least 59Gy) as outlined in the protocol.</li><li>Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of multiple areas of active (growing) disease (active multifocal disease); tumors with contrast-enhancing tumor component crossing the midline (crossing the corpus callosum); extensive subependymal disease (tumor touching subependymal space is allowed); or extensive <a href="../leptomeningeal-disease" class="trial--link-to-condition-in-text">leptomeningeal disease</a> (tumor touching leptomeninges is allowed).</li><li>Patients with undetectable anti-tetanus toxoid immunoglobulin G (IgG).</li><li>Patients with known history of agammaglobulinemia.</li><li>Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to admission for PVSRIPO infusion.</li><li>Patients with worsening steroid <a href="../myopathy" class="trial--link-to-condition-in-text">myopathy</a> (history of gradual progression of bilateral proximal muscle weakness, and <a href="../atrophy" class="trial--link-to-condition-in-text">atrophy</a> of proximal muscle groups).</li><li>Patients with prior, unrelated malignancy requiring current active treatment with the exception of <a href="../cervical-cancer" class="trial--link-to-condition-in-text">cervical carcinoma</a> in situ and adequately treated basal cell or <a href="../squamous-cell-carcinoma" class="trial--link-to-condition-in-text">squamous cell carcinoma</a> of the skin.</li><li>For patients randomized prior to V7, a known history of hypersensitivity to lomustine, dacarbazine, or any components of lomustine.</li><li>Patients with active <a href="../autoimmune-disease" class="trial--link-to-condition-in-text">autoimmune disease</a> requiring systemic immunomodulatory treatment within the past 3 months.</li></ol></div></div></div></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 Neurological Surgery</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Francisco</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94941</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">University Hospitals Cleveland Medical Center</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Cleveland</span><span class="comma-list-item" itemprop="addressRegion"> Ohio</span><span class="comma-list-item" itemprop="postalCode"> 44106</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></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"> in progress, not accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2017-06-01">June 2017</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2024-03-31">March 2024</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Istari Oncology, Inc.</dd><dt class="col-sm-3 text-sm-right">Links</dt><dd class="col-sm-9"> <a href="https://tischbraintumorcenter.duke.edu/" class="trial--link-to-external-study-link d-block" target="_blank" rel="noopener ugc nofollow"><i class="fa fa-link" aria-hidden="true"></i> The Preston Robert Tisch Brain Tumor Center at Duke University</a> </dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/ct2/show/NCT02986178" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT02986178</a> </dd><dt class="col-sm-3 text-sm-right">Phase</dt><dd class="col-sm-9">Phase 2 Glioma 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 122 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="2023-09-26">September 2023</time></span></dd></dl></div></div> </div><div class="col-md-3 text-center offset-lg-1 d-none d-md-block 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