An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
OBJECTIVES:
- Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or
keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing
cancer.
- 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
unacceptable toxicity.
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
study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
toxicity
during treatment
Yes
Robert B. Montgomery, MD
Study Chair
Department of Veterans Affairs
United States: Federal Government
CDR0000068824
NCT00023634
June 2001
November 2008
Name | Location |
---|---|
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 |