Vaccine Therapy in Treating Patients With Breast Cancer
This trial is active, not recruiting.
|Treatments||gp2 peptide + gm-csf vaccine, gm-csf (sargramostim), ae37 + gm-csf vaccine|
|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|
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|
|Washington, DC||Sibley Memorial Hospital||no longer recruiting|
|Honolulu, HI||University of Hawaii Cancer Center||no longer recruiting|
|Baltimore, MD||MedStar Good Samaritan Hospital Cancer Center||no longer recruiting|
|Baltimore, MD||MedStar Union Memorial Hospital||no longer recruiting|
|Bethesda, MD||Walter Reed National Military Medical Center||no longer recruiting|
|Winston-Salem, NC||Wake Forest University Comprehensive Cancer Center||no longer recruiting|
|Fort Hood, TX||Carl R. Darnall Army Medical Center||no longer recruiting|
|Fort Sam Houston, TX||San Antonio Army Medical Center||no longer recruiting|
|Houston, TX||University of Texas MD Anderson Cancer Center||no longer recruiting|
|San Antonio, TX||STOH Clinical Research||no longer recruiting|
|Tacoma, WA||Madigan Army Medical Center - Tacoma||no longer recruiting|
|Landstuhl, Germany||Landstuhl Regional Medical Center||no longer recruiting|
|Athens, Greece||Saint Savas Cancer Hospital of Athens||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
time frame: Five years (from date of enrollment to the study through the end of the follow-up period)
time frame: Local and systemic reactions to each inoculation will be monitored every six months during the regular inoculation series and the booster series.
time frame: Immune response will be measured after every monthly inoculation in the regular inoculation series and after each inoculation in the booster series
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)
|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.|
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