GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas
Description
The purpose of this phase I trial is to test the safety of combining GMCI, an immunostimulator, plus nivolumab, an immune checkpoint inhibitor (ICI), with standard of care radiation therapy, and temozolomide in treating patients with newly diagnosed high-grade gliomas. Gene Mediated Cytotoxic Immunotherapy (GMCI) involves the use of aglatimagene besadenovec (AdV-tk) injection into the tumor site and oral valacyclovir to kill tumor cells and stimulate the immune system. Nivolumab is an immune checkpoint inhibitor that may also stimulate the immune system by blocking the PD-1 immune suppressive pathway. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors and temozolomide is a chemotherapy drug that kills tumor cells. Giving GMCI, nivolumab, radiation therapy, and temozolomide may work better in treating patients with high-grade gliomas
Study Start Date
February, 27 2018
Estimated Completion Date
January 2022
Interventions
- Biological: AdV-tk
- Drug: Temozolomide
- Drug: Valacyclovir
- Radiation: Radiation
- Other: Laboratory Biomarker Analysis
- Biological: Nivolumab
Study ID
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins -- ABTC-1603
Status
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Error Details:
| struct | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Cause |
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| Detail | An exception occurred while invoking an event handler method from Application.cfc. The method name is: onRequest. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Message | Event handler exception. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RootCause |
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| StackTrace | coldfusion.runtime.EventHandlerException: Event handler exception. at coldfusion.runtime.AppEventInvoker.onRequest(AppEventInvoker.java:309) at coldfusion.filter.ApplicationFilter.invoke(ApplicationFilter.java:470) at coldfusion.filter.RequestMonitorFilter.invoke(RequestMonitorFilter.java:42) at coldfusion.filter.MonitoringFilter.invoke(MonitoringFilter.java:40) at coldfusion.filter.PathFilter.invoke(PathFilter.java:153) at coldfusion.filter.ExceptionFilter.invoke(ExceptionFilter.java:94) at coldfusion.filter.BrowserDebugFilter.invoke(BrowserDebugFilter.java:78) at coldfusion.filter.ClientScopePersistenceFilter.invoke(ClientScopePersistenceFilter.java:28) at coldfusion.filter.BrowserFilter.invoke(BrowserFilter.java:38) at coldfusion.filter.NoCacheFilter.invoke(NoCacheFilter.java:58) at coldfusion.filter.GlobalsFilter.invoke(GlobalsFilter.java:38) at coldfusion.filter.DatasourceFilter.invoke(DatasourceFilter.java:22) at coldfusion.filter.CachingFilter.invoke(CachingFilter.java:62) at coldfusion.CfmServlet.service(CfmServlet.java:219) at coldfusion.bootstrap.BootstrapServlet.service(BootstrapServlet.java:89) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:303) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at coldfusion.monitor.event.MonitoringServletFilter.doFilter(MonitoringServletFilter.java:42) at coldfusion.bootstrap.BootstrapFilter.doFilter(BootstrapFilter.java:46) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:241) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at coldfusion.inspect.weinre.MobileDeviceDomInspectionFilter.doFilter(MobileDeviceDomInspectionFilter.java:57) at coldfusion.bootstrap.BootstrapFilter.doFilter(BootstrapFilter.java:46) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:241) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at org.apache.catalina.core.StandardWrapperValve.invoke(StandardWrapperValve.java:219) at org.apache.catalina.core.StandardContextValve.invoke(StandardContextValve.java:110) at org.apache.catalina.authenticator.AuthenticatorBase.invoke(AuthenticatorBase.java:494) at org.apache.catalina.core.StandardHostValve.invoke(StandardHostValve.java:169) at org.apache.catalina.valves.ErrorReportValve.invoke(ErrorReportValve.java:104) at org.apache.catalina.core.StandardEngineValve.invoke(StandardEngineValve.java:116) at org.apache.catalina.connector.CoyoteAdapter.service(CoyoteAdapter.java:458) at org.apache.coyote.ajp.AjpProcessor.process(AjpProcessor.java:196) at org.apache.coyote.AbstractProtocol$AbstractConnectionHandler.process(AbstractProtocol.java:637) at org.apache.tomcat.util.net.JIoEndpoint$SocketProcessor.run(JIoEndpoint.java:316) at java.util.concurrent.ThreadPoolExecutor.runWorker(Unknown Source) at java.util.concurrent.ThreadPoolExecutor$Worker.run(Unknown Source) at org.apache.tomcat.util.threads.TaskThread$WrappingRunnable.run(TaskThread.java:61) at java.lang.Thread.run(Unknown Source) Caused by: coldfusion.runtime.CFPage$InvalidDateException: Date value passed to date function DateDiff is unspecified or invalid. at coldfusion.runtime.CFPage.DateDiff(CFPage.java:1604) at cftrial2ddetails2ecfm1310202973.runPage(C:\inetpub\wwwroot\trial-details.cfm:187) at coldfusion.runtime.CfJspPage.invoke(CfJspPage.java:247) at coldfusion.tagext.lang.IncludeTag.handlePageInvoke(IncludeTag.java:736) at coldfusion.tagext.lang.IncludeTag.doStartTag(IncludeTag.java:572) at coldfusion.runtime.CfJspPage._emptyTcfTag(CfJspPage.java:3011) at cfindex2ecfm944125949._factor8(C:\inetpub\wwwroot\index.cfm:302) at cfindex2ecfm944125949.runPage(C:\inetpub\wwwroot\index.cfm:1) at coldfusion.runtime.CfJspPage.invoke(CfJspPage.java:247) at coldfusion.tagext.lang.IncludeTag.handlePageInvoke(IncludeTag.java:736) at coldfusion.tagext.lang.IncludeTag.doStartTag(IncludeTag.java:572) at coldfusion.runtime.CfJspPage._emptyTcfTag(CfJspPage.java:3011) at cfApplication2ecfc953308886$funcONREQUEST.runFunction(C:\inetpub\wwwroot\Application.cfc:147) at coldfusion.runtime.UDFMethod.invoke(UDFMethod.java:487) at coldfusion.runtime.UDFMethod$ReturnTypeFilter.invoke(UDFMethod.java:420) at coldfusion.runtime.UDFMethod$ArgumentCollectionFilter.invoke(UDFMethod.java:383) at coldfusion.filter.FunctionAccessFilter.invoke(FunctionAccessFilter.java:95) at coldfusion.runtime.UDFMethod.runFilterChain(UDFMethod.java:334) at coldfusion.runtime.UDFMethod.invoke(UDFMethod.java:231) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:646) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:435) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:405) at coldfusion.runtime.AppEventInvoker.invoke(AppEventInvoker.java:108) at coldfusion.runtime.AppEventInvoker.onRequest(AppEventInvoker.java:301) ... 38 more | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Suppressed |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| TagContext |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Type | Expression | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| name | onRequest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Session:
| struct | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| authorized | no | ||||||||||||
| cfid | 8667455 | ||||||||||||
| cftoken | ef48e6068bddac07-BA9CEDA5-5056-B902-14D1BD0EE4C95228 | ||||||||||||
| confirm_token | 0 | ||||||||||||
| confirmed_ind | 0 | ||||||||||||
| country | [empty string] | ||||||||||||
| [empty string] | |||||||||||||
| fname | [empty string] | ||||||||||||
| last_login | [empty string] | ||||||||||||
| lname | [empty string] | ||||||||||||
| locstruct |
|
||||||||||||
| opt_in_ind | 0 | ||||||||||||
| profession | [empty string] | ||||||||||||
| professiontblvar | REF_PROFESSION | ||||||||||||
| refspecialtytblvar | REF_SPECIALTY | ||||||||||||
| refspectblvar | REF_SPEC | ||||||||||||
| sessionid | CLINICALTRIALSLOCATOR_PROD_8667455_ef48e6068bddac07-BA9CEDA5-5056-B902-14D1BD0EE4C95228 | ||||||||||||
| spec_id | [empty string] | ||||||||||||
| sponsored_modal | 0 | ||||||||||||
| state_cd | [empty string] | ||||||||||||
| u_spec | [empty string] | ||||||||||||
| urltoken | CFID=8667455&CFTOKEN=ef48e6068bddac07-BA9CEDA5-5056-B902-14D1BD0EE4C95228 | ||||||||||||
| user_id | [empty string] | ||||||||||||
| user_type | [empty string] | ||||||||||||
| zip | [empty string] | ||||||||||||
Form:
| struct [empty] |
|---|
CGI:
| struct | |
|---|---|
| AUTH_PASSWORD | [empty string] |
| AUTH_TYPE | [empty string] |
| AUTH_USER | [empty string] |
| CERT_COOKIE | [empty string] |
| CERT_FLAGS | [empty string] |
| CERT_ISSUER | [empty string] |
| CERT_KEYSIZE | 256 |
| CERT_SECRETKEYSIZE | 4096 |
| CERT_SERIALNUMBER | [empty string] |
| CERT_SERVER_ISSUER | C=US, S=Arizona, L=Scottsdale, O="GoDaddy.com, Inc.", OU=http://certs.godaddy.com/repository/, CN=Go Daddy Secure Certificate Authority - G2 |
| CERT_SERVER_SUBJECT | OU=Domain Control Validated, CN=*.clinicaltrialslocator.com |
| CERT_SUBJECT | [empty string] |
| CF_TEMPLATE_PATH | C:\inetpub\wwwroot\index.cfm |
| CONTENT_LENGTH | 0 |
| CONTENT_TYPE | [empty string] |
| CONTEXT_PATH | [empty string] |
| GATEWAY_INTERFACE | CGI/1.1 |
| HTTPS | on |
| HTTPS_KEYSIZE | 256 |
| HTTPS_SECRETKEYSIZE | 4096 |
| HTTPS_SERVER_ISSUER | C=US, S=Arizona, L=Scottsdale, O="GoDaddy.com, Inc.", OU=http://certs.godaddy.com/repository/, CN=Go Daddy Secure Certificate Authority - G2 |
| HTTPS_SERVER_SUBJECT | OU=Domain Control Validated, CN=*.clinicaltrialslocator.com |
| HTTP_ACCEPT | text/html,application/xhtml+xml,application/xml;q=0.9,*/*;q=0.8 |
| HTTP_ACCEPT_ENCODING | br,gzip |
| HTTP_ACCEPT_LANGUAGE | en-US,en;q=0.5 |
| HTTP_CONNECTION | Keep-Alive |
| HTTP_COOKIE | [empty string] |
| HTTP_HOST | clinicaltrialslocator.com |
| HTTP_REFERER | [empty string] |
| HTTP_URL | [empty string] |
| HTTP_USER_AGENT | CCBot/2.0 (https://commoncrawl.org/faq/) |
| LOCAL_ADDR | www.clinicaltrialslocator.com |
| PATH_INFO | /index.cfm |
| PATH_TRANSLATED | C:\inetpub\wwwroot\index.cfm |
| QUERY_STRING | pg=trial-details&nct_id=NCT03576612&srch_radius=0&srch_zip=06828&srch_phase=&alpha_filter=A&actively_recruiting=Y&srch_condition= |
| REMOTE_ADDR | 35.172.233.2 |
| REMOTE_HOST | 35.172.233.2 |
| REMOTE_USER | [empty string] |
| REQUEST_METHOD | GET |
| SCRIPT_NAME | /index.cfm |
| SERVER_NAME | clinicaltrialslocator.com |
| SERVER_PORT | 443 |
| SERVER_PORT_SECURE | 1 |
| SERVER_PROTOCOL | HTTP/1.1 |
| SERVER_SOFTWARE | Microsoft-IIS/8.5 |
| WEB_SERVER_API | [empty string] |
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