Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients
- To determine if the GP2 peptide/GM-CSF vaccine reduces the recurrence rate in
HLA-A2-positive, HER2/neu-positive, node-positive, or high-risk node-negative breast
cancer patients randomized to receive the vaccine versus the immunoadjuvant,
sargramostim (GM-CSF), alone.
- To determine if the AE37 peptide/GM-CSF vaccine reduces the recurrence rate in
HLA-A2-negative, HER2/neu-positive, node-positive or high-risk node-negative breast
cancer patients randomized to receive the vaccine versus the immunoadjuvant, GM-CSF,
- To monitor the invitro and invivo immunologic responses to the vaccines and correlate
these responses with the clinical outcomes.
- To monitor for any unexpected toxicities with the vaccines.
OUTLINE: This is a multicenter study. Patients are stratified according to nodal status.
Patients are randomized to 1 of 4 treatment arms.
- Arm I: HLA-A2-positive patients receive GP2 peptide/GM-CSF vaccine intradermally (ID)
every 3-4 weeks for a total of up to 6 inoculations.
- Arm II: HLA-A2-positive patients receive solely GM-CSF ID
- Arm III: HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4
weeks for a total of up to 6 inoculations.
- Arm IV: HLA-A2-negative patients receive solely GM-CSF ID
After completion of study therapy, patients are followed every 3 months for the first 24
months and then every 6 months for an additional 36 months.
Booster inoculations are administered at 12, 18, 24, and 30 months from the date of
patients' enrollment into the study. One booster inoculation is administered at each
timepoint (+/- 2 weeks) and will be the same inoculation (vaccine or GM-CSF only) as what
patients received during their regular inoculation series.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
The following will be compared: disease recurrence rates between HLA-A2-negative patients receiving the AE37 + GM-CSF vaccine and HLA-A2-negative patients receiving GM-CSF alone disease recurrence rates between HLA-A2-positive patients receiving the GP2 + GM-CSF vaccine and HLA-A2-positive patients receiving GM-CSF alone disease recurrence rates between all four arms of the trial.
Five years (from date of enrollment to the study through the end of the follow-up period)
Elizabeth A Mittendorf, MD, FACS
UT M.D. Anderson Cancer Center
United States: Food and Drug Administration
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Sibley Memorial Hospital||Washington, District of Columbia 20016|
|Madigan Army Medical Center - Tacoma||Tacoma, Washington 98431|
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|
|University of Hawaii Cancer Center||Honolulu, Hawaii 96813|
|Walter Reed National Military Medical Center||Bethesda, Maryland 20889|
|Carl R. Darnall Army Medical Center||Fort Hood, Texas 76544-4752|
|San Antonio Army Medical Center||Fort Sam Houston, Texas 78234-6200|
|STOH Clinical Research||San Antonio, Texas 78229|
|MedStar Union Memorial Hospital||Baltimore, Maryland 21218|
|MedStar Good Samaritan Hospital Cancer Center||Baltimore, Maryland 21239|