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| Sponsor: | Walter Reed Army Medical Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00524277 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: AE37 peptide/GM-CSF vaccine Biological: GP2 peptide/GM-CSF vaccine Biological: sargramostim |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind |
| Official Title: | Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine Versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine Versus GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence |
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
HLA-A2-positive patients receive GP2 peptide/GM-CSF vaccine intradermally (ID) every 3-4 weeks for a total of up to 6 inoculations. HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations. |
Biological: AE37 peptide/GM-CSF vaccine
Given intradermally
Biological: GP2 peptide/GM-CSF vaccine
Given intradermally
|
|
Arm II: Active Comparator
Patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations.
|
Biological: sargramostim
Given intradermally
|
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to nodal status. Patients are randomized to 1 of 2 treatment arms.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Meets one of the following criteria:
High-risk lymph node-negative breast cancer, defined by any one of the following criteria:
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, District of Columbia | |
| Sibley Memorial Hospital | Recruiting |
| Washington, District of Columbia, United States, 20016 | |
| Contact: Sheila Evans, RN, MS, AOCN 202-243-2320 sevans@sibley.org | |
| Walter Reed Army Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20307-5001 | |
| Contact: Diane Papay, RN 202-782-3877 | |
| United States, Hawaii | |
| Tripler Army Medical Center | Recruiting |
| Honolulu, Hawaii, United States, 96859 | |
| Contact: Jane Doll, RN 808-433-2857 | |
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Robin Petro, RN 336-713-4788 rpetro@wfubmc.edu | |
| United States, Texas | |
| Brooke Army Medical Center | Recruiting |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| Contact: Karen Parsons, BSN, RN 210-916-4837 | |
| Carl R. Darnall Army Medical Center | Recruiting |
| Fort Hood, Texas, United States, 76544-4752 | |
| Contact: Edna Figueroa-Dias, RN 254-288-8048 | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| Mary Crowley Medical Research Center at Sammons Cancer Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Clinical Trials Office - Mary Crowley Medical Research Center 214-370-1877 | |
| United States, Washington | |
| Madigan Army Medical Center - Tacoma | Recruiting |
| Tacoma, Washington, United States, 98431-5000 | |
| Contact: Shari Aynes, RN, CCRC 253-968-3891 | |
| Germany | |
| Landstuhl Regional Medical Center | Recruiting |
| Landstuhl, Germany, 66849 | |
| Contact: Mark G. Carmichael, MD 49-6371-86-8100 | |
| Greece | |
| Saint Savas Cancer Hospital of Athens | Recruiting |
| Athens, Greece, 11522 | |
| Contact: Michael Papamichail, MD, PhD 30-210-6409-624 papamichail@ciic.gr | |
| Study Chair: | George E. Peoples, MD | Brooke Army Medical Center |
More Information
| Study ID Numbers: | CDR0000562261, WRAMC-07-20029, WRAMC-9625-1186753655.52 |
| Study First Received: | August 31, 2007 |
| Last Updated: | June 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00524277 History of Changes |
| Health Authority: | Unspecified |
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stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer male breast cancer |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |