An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
- Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or
keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing
- Determine the preexisting antibody and T-cell responses to EGFRvIII in these patients.
- Determine the antibody and T-cell responses to EGFRvIII peptide after immunization with
this vaccine with GM-CSF or KLH as adjuvant.
OUTLINE: Patients are assigned to one of two treatment arms.
- Arm I: Patients receive a vaccine containing EGFRvIII peptide admixed with sargramostim
(GM-CSF) intradermally monthly.
- Arm II: Patients receive a vaccine containing EGFRvIII peptide admixed with keyhole
limpet hemocyanin subcutaneously monthly.
Treatment in both arms continues for 6 months in the absence of disease progression or
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Robert B. Montgomery, MD
Department of Veterans Affairs
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Swedish Cancer Institute at Swedish Medical Center - First Hill Campus||Seattle, Washington 98104|
|St. Joseph Hospital Community Cancer Center||Bellingham, Washington 98225|
|Olympic Hematology and Oncology||Bremerton, Washington 98310|
|Skagit Valley Hospital Cancer Care Center||Mt. Vernon, Washington 98273|
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|Harborview Medical Center||Seattle, Washington 98104|
|Group Health Central Hospital||Seattle, Washington 98104|
|North Puget Oncology at United General Hospital||Sedro-Wooley, Washington 98284|
|Cancer Care Northwest - Spokane South||Spokane, Washington 99202|
|Wenatchee Valley Clinic||Wenatchee, Washington 98801|
|Bay Regional Medical Center||Bay City, Michigan 48708|
|Mercy Regional Cancer Center at Mercy Hospital||Port Huron, Michigan 48060|