Diffuse Intrinsic Pontine Glioma

Clinical Trials for the Newly Diagnosed Child with DIPG


A review of www.clinicaltrials.gov was done on October 20, 2011 to identify which therapeutic trials are currently listed as open for the newly diagnosed child with DIPG. The following is information on the ten (10) listed trials that were listed as accruing patients as well as one vaccine trial that is yet to open. Clinicaltrials.gov seems to be often not be up to date on trial status. If you have interest or questions it might be wise to contact the primary investigator. Contact information is listed at the bottom of each clinical trial site. Most US clinical trials for DIPG can be found with the key word "pontine glioma" but some are still listed under "brainstem glioma".

*Note- many, if not most clinical trials will not allow you to enter a trial if you have already started treatment.

This information was taken from http://www.dipg.blogspot.com

Study Name Interventions Ages Location Study Contact Phone Verified
PDGFR Inhibitor Crenolanib in Children/Young Adults With Diffuse Intrinsic Pontine Glioma or Recurrent High-Grade Glioma DRUG: Crenolanib 18 mths-21 yrs St Jude (Memphis, TN) Cynthia Wetmore 901-595-6275 July 2011
Molecularly Determined Treatment of Diffuse Intrinsic Pontine Glioma DRUG: Bevacizumab
DRUG: Erlotinib
DRUG: Temozolomide
Radiation: Irradiation
3-18 yrs when open up to 20 locations- only Boston open on 10/20/11 Mark Kieran 617-632-4907 Sept 2011
Lenalidomide and Radiation Therapy in High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas  DRUG: Lenalidomide
RADIATION: Radiation Therapy
1-18 yrs NIH (Bethesda, MD) NCI Referral Office 1-888-NCI-1937 July 2011
A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Glioma  DRUG: Temozolomide
DRUG: Bevacizumab
DRUG: Irinotecan
3-30 yrs Cincinnati and Chicago Rebecca Turner, MS, CCRP 513-636-2799 July 2011
Cilengitide in Combination With Irradiation in Children With Diffuse Intrinsic Pontine Glioma  DRUG: Cilengitide dose escalation
DRUG: Cilengitide
Radiation: Concomitant radiotherapy
BIOLOGICAL: Pharmacokinetic
BIOLOGICAL: Pharmacogenetic
BIOLOGICAL: Exploratory investigation
6 mths-21 yrs France Pierre LEBLOND, MD

Yvette VENDEL, Sponsor CRA
(33)3 20 29 59 56

(33)3 20 29 59 40
July 2010
Phase I Rindopepimut After Conventional Radiation in Children w/ Diffuse Intrinsic Pontine Gliomas BIOLOGICAL: Rindopepimut 3-18 yrs Stanford (Palo Alto, CA) Paul Fisher, MD 650-497-8953 July 2011
Vorinostat and Radiation Therapy Followed By Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Pontine Glioma DRUG: Vorinostat
RADIATION: 3-dimensional conformal radiation therapy
RADIATION: intensity-modulated radiation therapy
3-21 yrs COG trial- Multiple Locations
Jack M. Su, MD

  April 2011
Pilot Study of  Glioma Associated Antigen Vaccines in Conjunction With Poly-ICLC in Pediatric Gliomas BIOLOGICAL: HLA-A2 restricted synthetic glioma antigen peptides vaccine
DRUG: Poly ICLC
GENETIC: Reverse transcriptase-polymerase chain reaction
OTHER: enzyme-linked immunosorbent assay
OTHER: flow cytometry
OTHER: immunohistochemisty staining method
OTHER: laboratory biomarker analysis
19 mths–20 yrs Pittsburgh, PA Angela Krol, BSN 412-692-8047 May 2010
External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas OTHER: cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan 3-21 yrs Multiple Locations Ira Dunkel, MD

Tanya Trippett, MD
212-639-2153

212-639-8267
Oct 2011
Valproic Acid and Radiation Followed by Maintenance Valproic Acid and Bevacizumab in Children With High Grade Gliomas  DRUG: Valproic acid
DRUG: Bevacizuma
Radiation: Radiation therapy
3-21 yrs POETIC study- several locations Jack Su, MD

Susan Blaney, MD
832-822-4306

832-822-4586
April 2011
Imiquimod/Brain Tumor Initiating Cell (BTIC) Vaccine in Brain Glioma (Not Yet Open) BIOLOGICAL: Brain tumor initiating cells
DRUG: Imiquimod
3-25 yrs Minneapolis, MN Christopher Moertel, MD

Tambra Dahlheimer, RN
612-626-2778

612-625-2994
Dec 2011
Convection-Enhanced Delivery of 124I-8H9 for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy RADIATION: Radioactive iodine-labeled monoclonal antibody 8H9 3-21 yrs New York & Maryland Mark Souweidane, MD

Ira Dunkel, MD
212-639-7056


212-639-2153
Dec 2011
Phase I/II Study of ABT-888 and Radiation, Followed by ABT-888 and Temozolomide, in Children With Newly Diagnosed Diffuse Pontine Gliomas (PBTC-033) DRUG:
ABT-888 Dose Level-1
DRUG:
ABT-888 Dose Level-2
DRUG:
ABT-888 Dose Level-3
DRUG:
ABT-888 Dose Level-4
DRUG:
ABT-888 Dose Level-5
Up to 21 Years Multiple Locations Patricia A Baxter, M.D.

Jack Su, M.D
832-824-4681


832-822-4306
Jan 2012


Finding Clinical Trials


The good news is that parents can search for clinical trials themselves.  From the synopsis of the trial, parents can review the inclusion/exclusion criteria, find where the trial is being offered and contact information of the investigators.  For completed studies, publications citations are included.

The bad news is that there is no one place to easily search for clinical trials.   Each site has its own advantages and disadvantages.  Here are some of the most useful sites...

Clincaltrials.gov is service of the NIH which registers federally and privately supported clinical trials in the US and around the world. There are over 56,000 trial listings including 155 countries.   One of the greatest advantages is that the site is the ability to search by keywords.   Examples of keywords include pontine glioma, brainstem glioma, intrinsic glioma and recurrent solid tumor.   For more detailed help on basic and advanced searches - Help for Searching ClinicalTrials.gov

The National Cancer Institute has a listing of over 6,000 clinical trials.  One of the features allows one to search specifically for trials under brain tumor, child, brainstem glioma.   One can also search location through a zip code.

The primary objective of the Pediatric Brain Tumor Consortium is to rapidly conduct phase 1 and 2 clinical evaluations of new therapeutic drugs, intrathecal agents, delivery technologies, biological therapies, and radiation treatment strategies in children through 21 years of age with primary CNS tumors. The PBTC includes nine leading academic institutions with extensive experience in the design and management of childhood cancer clinical trials for children with brain tumors. Another objective of the PBTC is to develop and coordinate innovative neuroimaging techniques on a consortium-wide basis.  Open and closed protocols are listed on this table.  PI (primary investigator) contact information and a parent summary are available for enrolling studies.

VirtualTrials.com is a private brain tumor site run through The Musella Foundation.  Chose the top button to find a drop down menu to ‘Find a Treatment’.  Two other very helpful pages on this site are:

The doctor/hospital address book

Brain Tumor Center (centers that do more than 50 brain tumors a year and some will provide free reviews of MRIs)

Often individual hospital will have listing of clinical trials that are going on at their institution.  You can search specific hospitals for this information as well.



Understanding Clinical Trials


The Clinical Trial Process by Larry Kun MD for the Pediatric Brain Tumor Foundation of the US defines and examines the clinical trials process, providing parents with a basic understanding of the steps involved in participating in a clinical trial.

Educational Materials About Clinical Trials
This site contains multiple informational articles on various aspects of clinical trials.

This information was taken from http://www.justonemoreday.org/TreatingPontineGliomas/ClinicalTrials.html