CDX-110 : Phase II/III

A Phase II/III Randomized Study of CDX-110 with Radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme

About the Clinical Trial

This research study will investigate the anticancer activity, impact on survival, and safety of the addition of CDX-110 vaccine to standard of care maintenance chemotherapy (with temozolomide) with radiation in patients with glioblastoma multiforme.

Enrolled patients will be randomly assigned to receive either standard of care maintenance chemotherapy with radiation, or standard of care plus intradermal injections of CDX-110 on a biweekly to monthly basis, continuing until progression of disease.

This Phase II/III study will be conducted in two stages. Approximately 90 patients will participate in the Phase II portion, and if results show an improvement in disease-free survival for the CDX-110 treated patients, an additional 285 participants will be enrolled in the Phase III portion.

Patient Eligibility

Major entry criteria include:

  • Newly diagnosed glioblastoma multiforme which expresses EGFRvIII (screening is included in pre-study evaluation) in patients 18 years of age or older.
  • Previous successful gross tumor resection (less than 1 cm2 residual disease)
  • Eligible for or have received standard chemoradiation with temozolomide without progression of disease

For more information on enrollment and open clinical trial sites, please contact Celldex Therapeutics at (908) – 454-7120 extension 305.

Open Clinical Trial Sites

  • MD Anderson, Houston, Texas 77030, United States
    Principal Investigator: Dr. Morris Groves, 713-792-2883, mgroves@mdanderson.org
    Site Coordinator: Teresa Hanna RN, 713-563-1603, thanna@mdanderson.org
  • University of California Los Angeles, Los Angeles, CA 90095, United States
    Principal Investigator: Dr. Linda Liau, 310-794-5664, LLiau@mednet.ucla.edu
    Site Coordinator: Emma Young, 310-267-2621, elyoung@mednet.ucla.edu
  • University of California Los Angeles, UCLA Division of Neurosurgery , David Geffen School of Medicine at UCLA
    10833 Le Conte Avenue, CHS 74-145, Los Angeles, CA 90095-1761, United States
    Principal Investigator: Linda Liau, MD, 310-794-5664, LLiau@mednet.ucla.edu
    Study Coordinator: Emma Young, 310-267-2621, elyoung@mednet.ucla.edu
  • University of California at San Francisco, San Francisco, CA, United States
    Principal Investigator: Dr. Nicholas Butowski, 415-353-2966, Butowski@neurosurg.ucsf.edu
    Site Coordinator: Valerie Kivett, 415-353-2076, KivettV@neurosurg.ucsf.edu
    Or: Theresa Freeman, 415-353-2076, FreemanT@neurosurg.ucsf.edu
  • Case Medical Center University Hospital, Cleveland, Ohio 44106, United States
    Principal Investigator: Dr. Andrew Sloan, 216-844-6054, andrew.sloan@uhhospitals.org
    Site Coordinator: Christopher Murphy RN, 216-983-0796, christopher.murphy@uhhospitals.org
  • University of Chicago, Chicago, IL 60637, United States
    Principal Investigator: Dr. Maciej (Matt) Lesniak, 773-834-4757, mlesniak@surgery.bsd.uchicago.edu
    Site Coordinator: Lori Loftis, 773-702-4632, lloftis@surgery.bsd.uchicago.edu
  • UCMA Inc | UC Hematology-Oncology Division
    234 Goodman Street, Barrett Cancer Center, Room 2009, Cincinnati, OH 45267-0501, 513-584-6194
    Principal Investigator: Margie Gerena-Lewis, MD, 513-584-6194, lewism2@ucmail.uc.edu
    Study Coordinator: Jamie McGuire, 513-584-2207, mcguirjn@ucmail.uc.edu
  • Cleveland Clinic, Cleveland, OH 44195, United States
    Principal Investigator: Dr. Mike Vogelbaum, 216-444-8564, vogelbm@neus.ccf.org
    Site Coordinator: Kathy Robinson, 216-445-8624, robinsk2@ccf.org
  • The Neurological Institute of Columbia University
    710 West 168th St, Room 204, New York, NY 10032, United States
    Principal Investigator: Rose Lai, MD, 212-305-1718, rlai@neuro.columbia.edu
    Site Coordinator: Mahogany Ayele, RN, 212-305-2756, maa2133@columbia.edu
  • Dana Farber Cancer Institute, Boston, MA 02115, United States
    Principal Investigator: Dr. Patrick Wen, 617-632-2166, patrick_wen@dfci.harvard.edu
    Site Coordinator: Laura Ebbeling, 617-632-5396, laura_ebbeling@dfci.harvard.edu
  • Duke University Brain Tumor Cancer Center, Durham, NC 27710, United States
    Principal Investigator: Dr. David Reardon, 919-668-2696, david.reardon@duke.edu
    Site Coordinator: Sharon McGee-Norman, 919-668-2696, sharon.mcgehee@duke.edu
  • University of Florida McKnight Brain Institute, Gainsville, FL 32611, United States
    Principal Investigator: Dr. Erin Dunbar, 352-273-9000, edunbar@neurosurgery.ufl.edu
    Site Coordinator: Christine Keeling, 352-273-9000, christine.keeling@neurosurgery.ufl.edu
  • Dent Neurological Institute, Amherst, NY 14226, United States
    Principal Investigator: Dr. Laszlo Mechtler, 716-250-2028, lmechtler@dentinstitute.com
    Site Coordinator: Lori Zdrojewski, 716-250-2055, lzdrojewski@dentinstitute.com
  • The Cancer Center at Hackensack University Medical, Hackensack, NJ 07601, United States
    Principal Investigator: Dr. Viswanathan Rajaraman, 201-342-2550, vrajaraman@optonline.net
    Site Coordinator: Kevin Barga, RN, 201-336-8017, kbarga@humed.com
  • Henry Ford Health System, 2799 W. Grand Blvd., CFP-560, Detroit, MI 48202, United States
    Principal Investigator: Tom Mikkelsen, MD, 313-916-1784, tmikkel1@hfhs.org
    Study Coordinator: Tiffany Pearce, 313-916-1784, tpearce1@hfhs.org
  • University of Iowa Hospitals, Iowa City, IA 52242, United States
    Principal Investigator: Dr. Thomas Carlisle, 319-356-7714, Thomas-carlisle@uiowa.edu
    Site Coordinator: Pamela Zehr, RN, 319-353-8914, pamela-zehr@uiowa.edu
  • Mayo Clinic, Jacksonville, FL 32224, United States
    Principal Investigator: Dr. Kent C. New
    Site Coordinator: Clinical Trials Referral Office, 507-538-7623
  • Mount Sinai School of Medicine, New York, NY 10029, United States
    Principal Investigator: Dr. Robert Aiken, 212-241-4503, robert.aiken@mssm.edu
    Site Coordinator: Mirela Toma, 212-241-0762, mirela.toma@mssm.edu
  • Evanston Northwestern Healthcare, Evanston, IL 60201, United States
    Principal Investigator: Dr. Nina Paleologos MD, 847-570-1808, npaleologos@enh.org
    Site Coordinator: Pat Lada, RN, 847-570-2025, plada@enh.org
  • Northwestern University, Feinberg School of Medicine, Chicago, IL 60611, United States
    Principal Investigator: Dr. Jeffrey Raizer, 312-503-4724, jraizer@nmff.org
    Site Coordinator: Lilia Gallot, 312-695-1363, l-gallot@northwestern.edu
  • University of Pennsylvania, Dept. of Neurosurgery, Philadelphia, PA 19104, United States
    Principal Investigator: Dr. James Schuster MD, 215-662-3487, james.schuster@uphs.upenn.edu
    Site Coordinator: Joanna Lopinto, RN, 215-615-4590, jlopinto@uphs.upenn.edu
  • Stanford Cancer Center, Stanford, CA 94305-5826, United States
    Principal Investigator: Dr. Larry Recht, MD, 650-725-8630, lrecht@stanford.edu
    Site Coordinator: Cathy Recht, RN, 650-725-8630, ckrecht@stanford.edu
  • St. Mary’s of Michigan/Field Neurosciences Institute, Saginaw, Michigan, United States
    Principal Investigator: Dr. Malcolm Field
    Site Coordinator: Heather Clark, 989-497-3023, hclark@stmarysofmichigan.org
    Or : Rich Herm, 989-497-3046, rherm@stmarysofmichigan.org
  • SUNY Upstate Medical University at Syracuse Department of Neurosurgery
    750 East Adams Street, Syracuse, NY 13210, United States
    Principal Investigator: Gregory Canute, MD, 315-464-5513, canuteg@upstate.edu
    Study Coordinator Lorraine Padden, 315-464-4894, PaddenL@upstate.edu
  • University of Utah Huntsman Cancer Institute, Salt Lake City, UT 84112, United States
    Principal Investigator: Dr. Randy Jensen, 801-581-6908, randy.jensen@hsc.utah.edu
    Site Coordinator: Lindsay Warner, 801-587-7604, lindsey.warner@hci.utah.edu
  • University of Virginia Health Systems, Charlottesville, VA, United States
    Principal Investigator: Dr. David Schiff, 434-982-4415, DS4JD@hscmail.mcc.virginia.edu
    Site Coordinator: Goga Radakovic, 434-243-6669, gr2p@virginia.edu
  • University of Washington School of Medicine and Fred Hutchinson Cancer Research Center, Seattle, WA 98195, United States
    Principal Investigator: Dr. Maciej Mrugala, 206-543-2340, mmrugala@u.washington.edu
    Site Coordinator: Robyn Haaf, RN, 206-616-7117, rhaaf@fhcrc.org
  • University of Texas at San Antonio, Department of Radiation, 7703 Floyd Curl Drive, Mail Code 7889, San Antonio, TX 78229, United States
    Principal Investigator: Dr. Aidnag Diaz, 210-450-1130, diaza5@uthscsa.edu
    Study Coordinator: Maria Roth, RN, 210-450-1230, rothm@uthscsa.edu
  • Yale University School of Medicine, New Haven, CT 06510, United States
    Principal Investigator: Dr. Joachim Baehring, 203-785-7284, Joachim.baehring@yale.edu
    Site Coordinator: Theresa Krause, RN, 203-785-3253, theresa.krause@yale.edu

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