Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments gp2 peptide + gm-csf vaccine, gm-csf (sargramostim), ae37 + gm-csf vaccine
Phase phase 2
Sponsor San Antonio Military Medical Center
Collaborator Antigen Express, Inc.
Start date January 2007
End date December 2016
Trial size 600 participants
Trial identifier NCT00524277, BAMC-C.2007.098, CDR0000562261, WRNMMC-20225

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(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.
gp2 peptide + gm-csf vaccine GM-CSF (sargramostim)
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
(Active Comparator)
HLA-A2-positive patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations.
gm-csf (sargramostim)
GM-CSF given intradermally very 3-4 weeks for a total of up to 6 inoculations
(Experimental)
HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations.
ae37 + gm-csf vaccine GM-CSF (sargramostim)
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
(Active Comparator)
HLA-A2-negative patients receive GM-CSF ID ID every 3-4 weeks for a total of up to 6 inoculations
gm-csf (sargramostim)
Given intradermally every 3-4 weeks for a total of up to 6 inoculations

Primary Outcomes

Measure
Disease recurrence
time frame: Five years (from date of enrollment to the study through the end of the follow-up period)

Secondary Outcomes

Measure
Safety
time frame: Local and systemic reactions to each inoculation will be monitored every six months during the regular inoculation series and the booster series.
Immune Response
time frame: Immune response will be measured after every monthly inoculation in the regular inoculation series and after each inoculation in the booster series

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: Inclusion criteria: 1. Lymph node-positive breast cancer or high-risk lymph node-negative breast cancer. The latter is defined by any one of the following criteria: - T2 disease - Grade 3 disease - Lymphovascular invasion - Estrogen receptor- or progesterone receptor-negative disease - HER2/neu-expressing tumor (immunohistochemistry [IHC] 3+ and/or amplified fluorescence in situ hybridization [FISH] >2.2, or N0 (i+)) 2. HER2/neu-expressing tumor (IHC 1-3+ and or positive FISH >1.2) 3. Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients' specific cancer) 4. Clinically cancer-free (no evidence of disease) 5. Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies 6. Good performance status (as defined in Exclusion Criteria) 7. Capable of informed consent Exclusion criteria: 1. HER2/neu-negative breast cancers (IHC 0) 2. Clinical and/or radiographic evidence of residual or persistent breast cancer 3. Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate 4. In poor health (Karnofsky <60%, ECOG >/-2) 5. Total bilirubin >1.8, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000) 6. Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease 7. Pregnancy (urine hCG) 8. Breast feeding 9. History of autoimmune disease 10. Involved in other experimental protocols (except with permission of the other study PI) PATIENT CHARACTERISTICS: Inclusion criteria: - Female or male - Menopausal status not specified - Immunologically intact by recall anergy testing - Negative pregnancy test Exclusion criteria: - Karnofsky 0-60% or ECOG ≥ 2 - Total bilirubin > 1.8 g/dL - Creatinine > 2.0 g/dL - Hemoglobin < 10.0 g/dL - Platelet count < 50,000/mm³ - WBC< 2,000/mm³ - Active pulmonary disease requiring medication that includes multiple inhalers - Pregnancy - Breastfeeding - History of autoimmune disease PRIOR CONCURRENT THERAPY: Inclusion criteria: - See Disease Characteristics Exclusion criteria: - Concurrent immunosuppressive therapy including chemotherapy, steroids, or methotrexate - Concurrent participation in another experimental treatment (except with permission of the other study investigator)

Additional Information

Official title 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
Principal investigator Elizabeth A Mittendorf, MD, FACS
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by San Antonio Military Medical Center.