Phase II Study of CDX-110 in Patients With Glioblastoma Multiforme (GBM) - Tabular View

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Descriptive Information Fields

Brief Title ^†

Phase II Study of CDX-110 in Patients With Glioblastoma Multiforme (GBM)

Official Title ^†

A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Brief Summary

CDX-110 is an immunotherapeutic molecule that is intended to induce a tumor-specific immune response to EGFRvIII positive brain cancer. Cells producing EGFRvIII have an enhanced capacity for unregulated growth, survival, invasion, and recruitment of new tumor blood vessels. This Phase II study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information.

Detailed Description

GBM continues to carry a very poor prognosis despite resection and chemo/radiation. At least 25% of cases of GBM express the constitutively activated EGFR mutation "variant III" (EGFRvIII), a tumor specific immunogenic antigen. Preliminary data from earlier studies suggests that vaccination against EGFRvIII after gross total resection and chemoradiation may provide an improvement in progression-free survival and overall survival.

This phase 2 study of CDX-110, also called the ACT III study, will evaluate the clinical activity of CDX-110 when given with maintenance temozolomide chemotherapy.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Progression Free Survival [ Time Frame: 5.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Immune Response [ Time Frame: No timeframe ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: No timeframe ] [ Designated as safety issue: No ]

Condition ^†

Glioblastoma

Intervention ^†

Drug: Temozolomide
Biological: CDX-110 EGFRvIII Vaccine / GM-CSF

MEDLINE PMIDs

Links

Official Site of Celldex Therapeutics (Sponsor) This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

375

Start Date ^†

April 2007

Completion Date

December 2010

Eligibility Criteria ^†

Inclusion Criteria:

Newly Diagnosed de novo GBM (must be one contiguous lesion; a second site of disease is exclusionary)
EGFRvIII positive (EGFRvIII expression is determined from archived tumor sample as part of initial study evaluation)
Gross Total Resection with less than 1cm2 residual tumor
Patients must be enrolled within 2-3 weeks of completing standard simultaneous radiation/temozolomide, and prior to receiving any additional therapies
18 Years and older
Karnofsky Performance Status of 70% or greater

Exclusion Criteria:

Leptomeningeal disease or Gliomatosis Cerebri
Systemic corticosteroid dosing of greater than 2 mg dexamethasone at entry
Active infection not already controlled with therapy
Stereotactic radiosurgery or Gliadel® Wafer

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Pfizer Oncology Clinical Trial Information Service

1-877-369-9753

PfizerCancerTrials@emergingmed.com

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00458601

Organization ID

Protocol CDX110-003

Secondary IDs ^††

Study Sponsor ^†

Celldex Therapeutics

Collaborators ^††

Investigators ^†

Principal Investigator:	Laszlo Mechtler, MD	Dent Neurological Institute
Principal Investigator:	Rose Lai, MD	The Neurological Institute of Columbia University
Principal Investigator:	Joachim Baehring, MD	Yale University
Principal Investigator:	James Schuster, MD	University of Pennsylvania, Dept of Neurosurgery
Principal Investigator:	Nina Paleologos, MD	Evanston Northwester Healthcare
Principal Investigator:	Maciej (Matt) Lesniak, MD	University of Chicago
Principal Investigator:	Larry Recht, MD	Stanford University
Principal Investigator:	Morris Groves, MD	M.D. Anderson Cancer Center
Principal Investigator:	Andrew Sloan, MD	University Hospital Case Medical Center
Principal Investigator:	Jan Drappatz, MD	Dana-Farber Cancer Institute
Principal Investigator:	Thomas Carlisle, MD	University of Iowa
Principal Investigator:	Jeffrey Raizer, MD	Northwestern University, Feinberg School of Medicine
Principal Investigator:	Robert Aiken, MD	Mount Sinai School of Medicine
Principal Investigator:	Mike Vogelbaum, MD, PhD	Cleveland Clinic
Principal Investigator:	Maciej Mrugala, MD	Univeristy of Washington School of Medicine and Fred Hutchinson Cancer Research Center
Principal Investigator:	Kurt Jaeckle, MD	Mayo Clinic
Principal Investigator:	Viswanathan Rajaraman, MD	The Cancer Center at Hackensack University Medical
Principal Investigator:	David Schiff, MD	University of Virginia Health Systems
Principal Investigator:	Nicholas Butowski, MD	University of California at San Francisco
Principal Investigator:	David Reardon, MD	The Brain Tumor Center at Duke
Principal Investigator:	Malcom Field, MD	St. Mary's of Michigan Field Neurosciences Institute
Principal Investigator:	Randy Jensen, MD	University of Utah
Principal Investigator:	Erin Dunbar, MD	University of Florida
Principal Investigator:	Aidnag Diaz, MD	The University of Texas Health Science Center at San Antonio
Principal Investigator:	Linda Liau, MD	University of California, Los Angeles
Principal Investigator:	Tom Mikkelsen, MD	Henry Ford Health System
Principal Investigator:	Gregory Canute, MD	SUNY Upstate Medical University at Syracuse
Principal Investigator:	Margie Gerena-Lewis, MD	UCMA Inc UC Hematology-Oncology Division
Principal Investigator:	Theodore Schwartz, MD	Weil Cornell Medical College
Principal Investigator:	Muhammad Hamdan, MD	Edward W. Sparrow Hospital Association Sparrow Regional Cancer Center
Principal Investigator:	Michael Lim, MD	The John's Hopkins University Neurology and Neurosurgery
Principal Investigator:	Thomas Chen, MD	University of Southern California
Principal Investigator:	Costas Hadjipanayis, MD	Winship Cancer Institute, Emory University School of Medicine
Principal Investigator:	Daniela Bota, MD	University of California Irvine Chao Family Comprehensive Cancer Center

Information Provided By

Celldex Therapeutics

Verification Date

December 2008

First Received Date ^†

April 10, 2007

Last Updated Date

December 31, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.