Lawrence Recht
Phase II/III Study of CDX-110 in Patients With Glioblastoma Multiforme (GBM) (ACT III)
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: Temozolomide
- Vaccine: CDX-110 EGFRvIII Vaccine / GM-CSF
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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 or older
- KPS 70 or greater
Key Exclusion Criteria:
- Leptomeningeal disease or Gliomatosis Cerebri
- Systemic corticosteroid dosing of greater than 2 mg dexamethasone at entry
- active infection
- stereotactic radiosurgery or Glidel Wafer
Additional Study Details
Official Title:
A Phase II/III Randomized Study of CDX-110 with Radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma MultiformeAnticipated start date:
7/13/2007Lead Sponsor:
Pfizer PharmaceuticalsCollaborator(s):
- Celldex Therapeutics
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Progression Free Survival at 6 months in Phase II
- Median Overall Survival in Phase III
Secondary Outcomes:
- Safety
- Immune Response rate
Total Number to be Enrolled:
375Total Number to be Enrolled at Stanford:
15More Information
Secondary ID(s):
- 97840
- BRN0004
- CDX110-003
- NCT00458601
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
11/13/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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