Peptide Vaccine for Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Herbert Lyerly
Must be taking: Endocrine therapies
Must not be taking: Steroids, Immuno-suppressives
Disqualifiers: Autoimmune disease, Cardiac disease, Metastases, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing a new vaccine made from small pieces of breast cancer proteins, combined with substances that boost the immune system. It targets patients with estrogen receptor positive breast cancer who do not respond well to hormone treatments. The goal is to see if this vaccine is safe and if it can help the immune system fight the cancer more effectively.
Will I have to stop taking my current medications?
The trial allows ongoing endocrine therapies if they have been taken for at least 3 months before joining. However, you cannot be on chemotherapy, radiation, or immunotherapy, and you must stop any steroid therapy at least 6 weeks before starting the trial.
What data supports the effectiveness of the treatment ESR1 peptide vaccine, Cancer Peptides Plus GM-CSF and Adjuvant for breast cancer?
Research shows that peptide vaccines, like the E75 + GM-CSF vaccine, can safely stimulate immune responses in breast cancer patients, suggesting potential effectiveness. Peptide-based vaccines have been shown to trigger specific immune responses against tumor cells, which may help in treating breast cancer.12345
Is the peptide vaccine for breast cancer safe for humans?
How is the ESR1 peptide vaccine treatment different from other breast cancer treatments?
The ESR1 peptide vaccine treatment is unique because it uses specific protein fragments (peptides) to stimulate the immune system to target breast cancer cells, potentially offering a more targeted and less toxic approach compared to traditional therapies. It includes an adjuvant (GM-CSF) to enhance the immune response, which is not a standard component in most breast cancer treatments.23459
Eligibility Criteria
This trial is for adults over 18 with a specific type of breast cancer that's been surgically removed but hasn't spread far. They should have finished any standard treatments like chemo at least 4 weeks ago and can't be more than 5 years out from those treatments. Their cancer must be estrogen receptor positive, they need to have certain immune system markers (HLA A0201+), and their organs must function well.Inclusion Criteria
I have been on hormone therapy for at least 3 months.
My breast cancer was surgically removed, was large or spread to lymph nodes, but not to other parts of my body.
My breast cancer was surgically removed, is ER positive, and I have the HLA A0201+ gene.
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Exclusion Criteria
I currently have an infection such as a UTI, HIV, or hepatitis.
Allergies to any component of the vaccine
I have had my spleen removed.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 200 mcg ESR1 peptides plus 1ml Montanide and 100 mcg GM-CSF administered subcutaneously over 6 weeks
6 weeks
6 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
44 days
Long-term follow-up
Detection of ESR mutant-specific memory T cells against at least one of the 5 immunizing peptides by Cytof analysis
2 years
Treatment Details
Interventions
- ESR1 peptide vaccine (Cancer Vaccine)
Trial OverviewThe study tests a new vaccine made from cancer peptides targeting the estrogen receptor, combined with GM-CSF and Montanide ISA adjuvant to boost immune response. It aims to check safety first, then how well it triggers an immune reaction in patients who've resisted hormone therapy.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ESR1 peptide vaccineExperimental Treatment1 Intervention
200 mcg ESR1 peptides plus 1ml Montanide and 100 mcg GM-CSF administered subcutaneously weeks 0, 1, 2, 4, 5, 6 for a total of 6 injections.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Medical CenterDurham, NC
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Who Is Running the Clinical Trial?
Herbert LyerlyLead Sponsor
References
The feasibility of using an autologous GM-CSF-secreting breast cancer vaccine to induce immunity in patients with stage II-III and metastatic breast cancers. [2023]The antigenic targets of immunity and the role of vaccination in breast cancer are unknown. We performed a phase I study of an autologous GM-CSF-secreting breast cancer vaccine in patients with metastatic and stage II-III breast cancer.
Peptide vaccines in breast cancer: The immunological basis for clinical response. [2022]This review discusses peptide-based vaccines in breast cancer, immune responses and clinical outcomes, which include studies on animal models and phase I, phase I/II, phase II and phase III clinical trials. Peptide-based vaccines are powerful neoadjuvant immunotherapies that can directly target proteins expressed in tumor cells, mainly tumor-associated antigens (TAAs). The most common breast cancer TAA epitopes are derived from MUC1, HER2/neu and CEA proteins. Peptides derived from TAAs could be successfully used to elicit CD8 and CD4 T cell-specific responses. Thus, choosing peptides that adapt to natural variations of human leukocyte antigen (HLA) genes is critical. The most attractive advantage is that the target response is more specific and less toxic than for other therapies and vaccines. Prominent studies on NeuVax - E75 (epitope for HER2/neu and GM-CSF) in breast cancer and DPX-0907 (HLA-A2-TAAs) expressed in breast cancer, ovarian and prostate cancer have shown the efficacy of peptide-based vaccines as neoadjuvant immunotherapy against cancer. Future peptide vaccine strategies, although a challenge to be applied in a broad range of breast cancers, point to the development of degenerate multi-epitope immunogens against multiple targets.
Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. [2020]E75, a HER2/neu immunogenic peptide, is expressed in breast cancer (BCa). We have performed clinical trials of E75 + GM-CSF vaccine in disease-free, node-positive and node-negative BCa patients at high recurrence risk and recurrences were noted in both control and vaccine groups.
Use of booster inoculations to sustain the clinical effect of an adjuvant breast cancer vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. [2014]The authors are conducting clinical trials of the HER-2/neu E75-peptide vaccine in clinically disease-free breast cancer (BC) patients. Their phase 1-2 trials revealed that the E75 + granulocyte-macrophage colony-stimulating factor (GM-CSF) vaccine is safe and effective in stimulating clonal expansion of E75-specific CD8(+) T cells. They assessed the need for and response to a booster after completion of primary vaccination series.
Peptide-based vaccination and induction of CD8+ T-cell responses against tumor antigens in breast cancer. [2020]Tumor-associated antigens (TAAs) have been identified in many malignant tumors. Within these TAAs are peptide sequences that bind major histocompatibility complex (MHC) class I and class II molecules recognized by T cells triggering antigen-specific CD8+ cytotoxic T-cell and CD4+ T-helper cell responses. Efforts to develop vaccines for breast cancer have been underway for more than 20 years, including peptide and whole inactivated tumor cell vaccines as well as antigen-loaded dendritic cell vaccines. The majority of vaccine trials have used peptides, including single-peptide and multiple-peptide formulations using either MHC class I and class II epitopes in oil-based emulsions alone or in combination with an adjuvant, such as granulocyte-macrophage colony-stimulating factor, and Toll-like receptor agonists. Preclinical research in vitro and in animal models has been aimed at improving vaccine efficacy by identifying more immunogenic peptides and combinations of peptides and adjuvants and cytokine adjuvants that induce stronger immune responses and prolong T-cell memory. Clinical studies investigating the therapeutic potential of active immunization using peptide vaccines has found no serious side effects. In this review, we examine TAA peptide-based vaccination regimens showing promise in breast cancer patients that are also being investigated in clinical trials of safety and efficacy. We also discuss the current limitations in the peptide vaccination field and areas for future development.
Early phase II study of mixed 19-peptide vaccine monotherapy for refractory triple-negative breast cancer. [2021]We undertook an early phase II study of mixed 19-peptide cancer vaccine monotherapy for 14 advanced metastatic triple-negative breast cancer (mTNBC) patients refractory to systemic chemotherapy to develop a new type of cancer vaccine. The treatment protocol consisted of a weekly vaccination for 6 weeks, and there were no severe adverse events related to the vaccination throughout the trial. Increase of peptide-specific IgG against the vaccinated human leukocyte antigen-matched peptides, but not against the nonmatched peptides, was positively correlated with overall survival (OS) (P
A phase I study of personalized peptide vaccination using 14 kinds of vaccine in combination with low-dose estramustine in HLA-A24-positive patients with castration-resistant prostate cancer. [2013]To evaluate the safety, tolerability, immune response, and antitumor activity of a combination of personalized peptide vaccination (PPV) and estramustine phosphate (EMP) in patients with castration-resistant prostate cancer (CRPC).
Individualized synthetic peptide vaccines with GM-CSF in locally advanced melanoma patients. [2012]We report on 10 patients with resected American Joint Committee on Cancer (AJCC)stage IIA-IIIC melanoma receiving individualized adjuvant peptide vaccinations derived from the melanosomal antigens MelanA/MART1, gp100 and tyrosinase, according to patient tumor associated HLA restricted antigen expression, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). Except for 1 patient, all patients had received systemic pretreatment with immunotherapy (n = 8), chemoimmunotherapy (n = 1), chemotherapy (n = 1), or cefalectin therapy (n = 1). Upon prior therapy, 7 of 10 patients had progressed with subcutaneous/cutaneous (n = 2), lymph node (n = 3), or subcutaneous/cutaneous and lymph node (n = 2)metastases, which were subsequently resected prior to vaccination. After a mean of 6.5 vaccination cycles, progression-free survival was 6 months (median, range 2-10). Five patients were relapse-free for 1+ up to 21+ months, 3 patients developed a solitary cutaneous metastasis, and 2 patients developed multiple metastases during vaccination. Overall, vaccine treatment was well tolerated, with no severe side-effects. Eight of 10 patients developed local delayed type hypersensitivity (DTH)reactions to synthetic peptides after the first or second injection. In 2 patients, transient fever, nausea, diarrhea, and muscle pain of National Cancer Institute (NCI)Grade I occurred. In summary, individualized synthetic peptide vaccination, combined with GM-CSF, was feasible and warrants further clinical investigation.
Optimal dose and schedule of an HER-2/neu (E75) peptide vaccine to prevent breast cancer recurrence: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. [2008]E75, a HER-2/neu-derived peptide, was administered as a preventive vaccine with granulocyte-macrophage-colony-stimulating factor (GM-CSF) in disease-free lymph node-positive (NP) and lymph node-negative (NN) breast cancer (BCa) patients. The optimal biologic dose (OBD) was determined based on toxicity and immunologic response.