Vaccine Therapy in Treating Patients With Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00524277 |
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Recruitment Status :
Completed
First Posted : September 3, 2007
Last Update Posted : March 30, 2020
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Sponsor:
San Antonio Military Medical Center
Collaborators:
NuGenerex Immuno-Oncology
Norwell, Inc.
Information provided by (Responsible Party):
COL George Peoples, MD, FACS, San Antonio Military Medical Center
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Biological: GP2 peptide + GM-CSF vaccine Biological: GM-CSF (sargramostim) Biological: AE37 + GM-CSF vaccine | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 456 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| 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 |
| Study Start Date : | January 2007 |
| Actual Primary Completion Date : | December 31, 2014 |
| Actual Study Completion Date : | March 31, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
Drug Information available for:
Sargramostim
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Biological: GP2 peptide + GM-CSF vaccine
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
Other Name: GM-CSF (sargramostim) |
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Active Comparator: Arm II
HLA-A2-positive patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations.
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Biological: GM-CSF (sargramostim)
GM-CSF given intradermally very 3-4 weeks for a total of up to 6 inoculations |
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Experimental: 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.
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Biological: AE37 + GM-CSF vaccine
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
Other Name: GM-CSF (sargramostim) |
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Active Comparator: Arm IV
HLA-A2-negative patients receive GM-CSF ID ID every 3-4 weeks for a total of up to 6 inoculations
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Biological: GM-CSF (sargramostim)
Given intradermally every 3-4 weeks for a total of up to 6 inoculations |
Primary Outcome Measures :
- Disease recurrence [ Time Frame: Five years (from date of enrollment to the study through the end of the follow-up period) ]
The following will be compared:
- disease recurrence rates between HLA-A2-negative patients receiving the AE37 + GM-CSF vaccine and HLA-A2-negative patients receiving GM-CSF alone
- disease recurrence rates between HLA-A2-positive patients receiving the GP2 + GM-CSF vaccine and HLA-A2-positive patients receiving GM-CSF alone
- disease recurrence rates between all four arms of the trial.
Secondary Outcome Measures :
- 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. ]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.
- 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 ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria:
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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+))
- HER2/neu-expressing tumor (IHC 1-3+ and or positive FISH >1.2)
- 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)
- Clinically cancer-free (no evidence of disease)
- Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies
- Good performance status (as defined in Exclusion Criteria)
- Capable of informed consent
Exclusion criteria:
- HER2/neu-negative breast cancers (IHC 0)
- Clinical and/or radiographic evidence of residual or persistent breast cancer
- Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
- In poor health (Karnofsky <60%, ECOG >/-2)
- Total bilirubin >1.8, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000)
- Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease
- Pregnancy (urine hCG)
- Breast feeding
- History of autoimmune disease
- 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524277
Locations
| United States, District of Columbia | |
| Sibley Memorial Hospital | |
| Washington, District of Columbia, United States, 20016 | |
| United States, Hawaii | |
| University of Hawaii Cancer Center | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Maryland | |
| MedStar Union Memorial Hospital | |
| Baltimore, Maryland, United States, 21218 | |
| MedStar Good Samaritan Hospital Cancer Center | |
| Baltimore, Maryland, United States, 21239 | |
| Walter Reed National Military Medical Center | |
| Bethesda, Maryland, United States, 20889 | |
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Texas | |
| Carl R. Darnall Army Medical Center | |
| Fort Hood, Texas, United States, 76544-4752 | |
| San Antonio Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| STOH Clinical Research | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Madigan Army Medical Center - Tacoma | |
| Tacoma, Washington, United States, 98431-5000 | |
| Germany | |
| Landstuhl Regional Medical Center | |
| Landstuhl, Kirchberg, Germany, 66849 | |
| Greece | |
| Saint Savas Cancer Hospital of Athens | |
| Athens, Greece, 11522 | |
Sponsors and Collaborators
San Antonio Military Medical Center
NuGenerex Immuno-Oncology
Norwell, Inc.
Investigators
| Principal Investigator: | Elizabeth A Mittendorf, MD, FACS | UT M.D. Anderson Cancer Center | |
| Study Director: | George E Peoples, MD, FACS | Cancer Vaccine Development Program, Department of Surgery, Brooke Army Medical Center |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | COL George Peoples, MD, FACS, Chief, Surgical Oncology, Brooke Army Medical Center; Director and Principal Investigator, Cancer Vaccine Development Program, San Antonio Military Medical Center |
| ClinicalTrials.gov Identifier: | NCT00524277 |
| Other Study ID Numbers: |
CDR0000562261 BAMC-C.2007.098 ( Other Identifier: BAMC Institutional Review Board ) WRNMMC-20225 ( Other Identifier: WRNMMC Institutional Review Board ) |
| First Posted: | September 3, 2007 Key Record Dates |
| Last Update Posted: | March 30, 2020 |
| Last Verified: | March 2020 |
Keywords provided by COL George Peoples, MD, FACS, San Antonio Military Medical Center:
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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 |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Molgramostim |
Vaccines Sargramostim Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |