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| Sponsored by: |
Celldex Therapeutics |
| Information provided by: | Celldex Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00458601 |
Purpose
CDX-110 is an immunotherapeutic molecule that is intended to induce a tumor-specific immune response in 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/III study is designed to determine whether the addition of CDX-110 vaccination to a standard of care regimen provides significant benefit for patients. ACT III will randomize patients with newly diagnosed, EGFRvIII positive, resected GBM who have already received standard chemoradiation (with temozolomide) to CDX-110 plus temozolomide maintenance therapy (standard of care) or temozolomide maintenance therapy alone (in a 2:1 ratio; investigational vaccine:active comparator). Treatment will continue until disease progression, and patients will be followed for Progression Free Survival and Overall Survival.
| Condition | Intervention | Phase |
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Glioblastoma |
Drug: Temozolomide Biological: CDX-110 EGFRvIII Vaccine / GM-CSF |
Phase II Phase III |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Temozolomide Sargramostim Granulocyte-macrophage colony-stimulating factor |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Phase II/III Randomized Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme |
| Estimated Enrollment: | 375 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Active Comparator
Standard of Care (maintenance temozolomide)
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Drug: Temozolomide
Temozolomide 150-200 mg/m2 on days 1-5 of 28-day cycles, for up to 12 cycles
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2: Experimental
Standard of care (maintenance temozolomide) plus CDX-110
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Biological: CDX-110 EGFRvIII Vaccine / GM-CSF
500 mcg CDX-110 with 150 mcg GM-CSF as a once monthly intradermal injection continuing until intolerance or progression
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GBM continues to carry a very poor prognosis despite resection and chemo/radiation. Approximately 45% of cases of GBM express the constitutively activated EGFR mutation "variant III" (EGFRvIII), a tumor specific immunogenic antigen. Historically controlled Phase II data suggest that vaccination against EGFRvIII after gross total resection and chemoradiation can approximately double Progression Free Survival and Overall Survival.
Comparison: ACT III will test these data in a randomized fashion (2:1 vaccine:control), comparing standard dose monthly temozolomide to the same chemotherapy given along with CDX-110 EGFRvIII vaccine. Patients will be followed for PFS and OS.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Celldex Therapeutics | 908-454-7120 ext 305 | clinicaloperations@celldextherapeutics.com |
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Show 34 Study Locations |
| Celldex Therapeutics |
| 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: | Kent C New, MD, PhD | 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 |
More Information
Official Site of Celldex Therapeutics (Sponsor)
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| Responsible Party: | Celldex Therapeutics ( Thomas Davis, M.D., Chief Medical Officer and VP Clinical Development ) |
| Study ID Numbers: | Protocol CDX110-003 |
| First Received: | April 10, 2007 |
| Last Updated: | November 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00458601 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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