Vaccine Therapy in Treating Patients With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Biological: GM-CSF (sargramostim)Biological: GP2 peptide + GM-CSF vaccineBiological: AE37 + GM-CSF vaccine
- Registration Number
- NCT00524277
- Lead Sponsor
- San Antonio Military Medical Center
- Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer.
PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.
- Detailed Description
OBJECTIVES:
* 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, alone.
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 456
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II GM-CSF (sargramostim) HLA-A2-positive patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations. Arm IV GM-CSF (sargramostim) HLA-A2-negative patients receive GM-CSF ID ID every 3-4 weeks for a total of up to 6 inoculations Arm I GP2 peptide + GM-CSF vaccine 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 III AE37 + GM-CSF vaccine HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations.
- Primary Outcome Measures
Name Time Method Disease recurrence Five years (from date of enrollment to the study through the end of the follow-up period) The following will be compared:
1. disease recurrence rates between HLA-A2-negative patients receiving the AE37 + GM-CSF vaccine and HLA-A2-negative patients receiving GM-CSF alone
2. disease recurrence rates between HLA-A2-positive patients receiving the GP2 + GM-CSF vaccine and HLA-A2-positive patients receiving GM-CSF alone
3. disease recurrence rates between all four arms of the trial.
- Secondary Outcome Measures
Name Time Method Immune Response Immune response will be measured after every monthly inoculation in the regular inoculation series and after each inoculation in the booster series Immune response will be measured by proliferation assays, dimer assays, and ELISPOT. Delayed type hypersensitivity reactions will be compared between the vaccinated group and GM-CSF-only group.
Safety Local and systemic reactions to each inoculation will be monitored every six months during the regular inoculation series and the booster series. Inoculations will be immediately halted if any serious adverse reactions occur which, when based upon appropriate judgment of the PI, are determined to jeopardize the patient or require medical or surgical intervention. Any death or grade 4 adverse drug experience found to be directly related to the experimental vaccine will result in suspension of patient enrollment to the study.
Trial Locations
- Locations (13)
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
University of Hawaii Cancer Center
🇺🇸Honolulu, Hawaii, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Carl R. Darnall Army Medical Center
🇺🇸Fort Hood, Texas, United States
San Antonio Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
STOH Clinical Research
🇺🇸San Antonio, Texas, United States
Madigan Army Medical Center - Tacoma
🇺🇸Tacoma, Washington, United States
Landstuhl Regional Medical Center
🇩🇪Landstuhl, Kirchberg, Germany
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Saint Savas Cancer Hospital of Athens
🇬🇷Athens, Greece
MedStar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
MedStar Good Samaritan Hospital Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States