Vaccine Therapy in Treating Patients With Breast Cancer
NCT ID: NCT00524277
Last Updated: 2020-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
456 participants
INTERVENTIONAL
2007-01-31
2017-03-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
GP2 peptide + GM-CSF vaccine
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
Arm II
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
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.
AE37 + GM-CSF vaccine
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
Arm IV
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
Interventions
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GP2 peptide + GM-CSF vaccine
Given intradermally 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
AE37 + GM-CSF vaccine
Given intradermally 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
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* Female or male
* Menopausal status not specified
* Immunologically intact by recall anergy testing
* Negative pregnancy test
* See Disease Characteristics
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:
* 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:
* Concurrent immunosuppressive therapy including chemotherapy, steroids, or methotrexate
* Concurrent participation in another experimental treatment (except with permission of the other study investigator)
18 Years
ALL
No
Sponsors
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NuGenerex Immuno-Oncology
INDUSTRY
Norwell, Inc.
INDUSTRY
San Antonio Military Medical Center
FED
Responsible Party
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COL George Peoples, MD, FACS
Chief, Surgical Oncology, Brooke Army Medical Center; Director and Principal Investigator, Cancer Vaccine Development Program
Principal Investigators
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Elizabeth A Mittendorf, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
UT M.D. Anderson Cancer Center
George E Peoples, MD, FACS
Role: STUDY_DIRECTOR
Cancer Vaccine Development Program, Department of Surgery, Brooke Army Medical Center
Locations
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Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
MedStar Good Samaritan Hospital Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 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
University of Texas MD Anderson Cancer Center
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
Saint Savas Cancer Hospital of Athens
Athens, , Greece
Countries
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References
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Mittendorf EA, Alatrash G, Xiao H, Clifton GT, Murray JL, Peoples GE. Breast cancer vaccines: ongoing National Cancer Institute-registered clinical trials. Expert Rev Vaccines. 2011 Jun;10(6):755-74. doi: 10.1586/erv.11.59.
Sears AK, Perez SA, Clifton GT, Benavides LC, Gates JD, Clive KS, Holmes JP, Shumway NM, Van Echo DC, Carmichael MG, Ponniah S, Baxevanis CN, Mittendorf EA, Papamichail M, Peoples GE. AE37: a novel T-cell-eliciting vaccine for breast cancer. Expert Opin Biol Ther. 2011 Nov;11(11):1543-50. doi: 10.1517/14712598.2011.616889. Epub 2011 Sep 6.
Jackson DO, Trappey FA, Clifton GT, Vreeland TJ, Peace KM, Hale DF, Litton JK, Murray JL, Perez SA, Papamichail M, Mittendorf EA, Peoples GE. Effects of HLA status and HER2 status on outcomes in breast cancer patients at risk for recurrence - Implications for vaccine trial design. Clin Immunol. 2018 Oct;195:28-35. doi: 10.1016/j.clim.2018.06.008. Epub 2018 Jul 17.
Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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BAMC-C.2007.098
Identifier Type: OTHER
Identifier Source: secondary_id
WRNMMC-20225
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000562261
Identifier Type: -
Identifier Source: org_study_id
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