RECRUITING

Cancer Peptides Plus GM-CSF and Adjuvant in Breast Cancer

Conditions

Breast Cancer estrogen receptor peptide vaccine immunotherapy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase I study looking at the safety of cancer peptides combined with adjuvant and GM-CSF in subjects with estrogen receptor (ESR) positive breast cancer. The primary objective of the study is to determine the safety of of the peptide vaccine. The secondary objective is to evaluate the immune response to the vaccine. The peptides used in this vaccine are derived from the estrogen receptor and are combined with the adjuvant Montanide ISA and GM-CSF to enhance their immune response. A peptide vaccine of these peptides may improve outcomes of patients with endocrine resistant breast cancer.

Official Title

A Phase I Study of Cancer Peptides Plus GM-CSF and Adjuvant Following Completion of Prescribed Systemic Therapy of Estrogen Receptor Positive Breast Cancer

Quick Facts

Study Start:2020-09-01

Study Completion:2027-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04270149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with histologically confirmed, resected, breast cancer with one of the following characteristics: * HLA A0201+ and tumor is ER+ * Patients must have completed any standard chemotherapy recommended by their physician. There must be at least 4 weeks from their last dose of chemotherapy (or surgery if no chemotherapy was given) prior to the first dose of study vaccine. There should be no more than 5 years from the time of completion of any chemotherapy, surgery or HER2 targeted therapy. Ongoing endocrine therapies are permitted as long as they have been administered for at least 3 months prior to study enrollment. * Age ≥ 18 years. * Heme: WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL, platelets ≥ 80,000/microliter. * Adequate, renal and hepatic function with serum creatinine \< 1.5 mg/dL, bilirubin \< 1.5 mg/dL (except a bilirubin of \<2.0 will be permitted for patents with Gilbert's syndrome), SGOT/SGPT \< 2 x upper limit of normal. * Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines.	* Subjects with concurrent chemotherapy, radiation therapy, or immunotherapy are excluded. There must be at least 4 weeks between these prior therapy and study treatment. Subjects must have recovered from all acute toxicities from prior treatment. Peripheral neuropathy grade 1 due to prior therapy will be permitted. * Subjects may not have history of distant metastases. * Subjects with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. A positive ANA (anti-nuclear antibody) test without other evidence of autoimmune disease will not exclude a subject for this study. A prior history of autoimmune hypothyroidism will not exclude a subject. * Subjects with serious intercurrent chronic or acute illness, such as cardiac disease, (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment. * Subjects with a medical or psychological impediment to probable compliance with the * Concurrent (or within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer. * Presence of an active acute or chronic infection including: an urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). Subjects with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; subjects with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections. * Subjects on steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Subjects must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment. * Subjects with allergies to any component of the vaccine * Pregnant or nursing mothers. * Subjects with acute or chronic skin disorders that will interfere with peptide injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded. * Splenectomy

Inclusion Criteria

Exclusion Criteria

* Patients with histologically confirmed, resected, breast cancer with one of the following characteristics:
* HLA A0201+ and tumor is ER+
* Patients must have completed any standard chemotherapy recommended by their physician. There must be at least 4 weeks from their last dose of chemotherapy (or surgery if no chemotherapy was given) prior to the first dose of study vaccine. There should be no more than 5 years from the time of completion of any chemotherapy, surgery or HER2 targeted therapy. Ongoing endocrine therapies are permitted as long as they have been administered for at least 3 months prior to study enrollment.
* Age ≥ 18 years.
* Heme: WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL, platelets ≥ 80,000/microliter.
* Adequate, renal and hepatic function with serum creatinine \< 1.5 mg/dL, bilirubin \< 1.5 mg/dL (except a bilirubin of \<2.0 will be permitted for patents with Gilbert's syndrome), SGOT/SGPT \< 2 x upper limit of normal.
* Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines.

* Subjects with concurrent chemotherapy, radiation therapy, or immunotherapy are excluded. There must be at least 4 weeks between these prior therapy and study treatment. Subjects must have recovered from all acute toxicities from prior treatment. Peripheral neuropathy grade 1 due to prior therapy will be permitted.
* Subjects may not have history of distant metastases.
* Subjects with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. A positive ANA (anti-nuclear antibody) test without other evidence of autoimmune disease will not exclude a subject for this study. A prior history of autoimmune hypothyroidism will not exclude a subject.
* Subjects with serious intercurrent chronic or acute illness, such as cardiac disease, (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
* Subjects with a medical or psychological impediment to probable compliance with the
* Concurrent (or within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer.
* Presence of an active acute or chronic infection including: an urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). Subjects with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; subjects with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
* Subjects on steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Subjects must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment.
* Subjects with allergies to any component of the vaccine
* Pregnant or nursing mothers.
* Subjects with acute or chronic skin disorders that will interfere with peptide injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.
* Splenectomy

Contacts and Locations

Study Contact

Amy Hobeika, PhD

CONTACT

919 684 6112

AMY.HOBEIKA@DUKE.EDU

Stacy Murray, BA, CCRP

CONTACT

(919) 684-7983

Stacy.Murray@duke.edu

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Herbert Lyerly

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-01

Study Completion Date2027-08-01

Study Record Updates

Study Start Date2020-09-01

Study Completion Date2027-08-01

Terms related to this study

Keywords Provided by Researchers

breast cancer
estrogen receptor
peptide vaccine
immunotherapy

Additional Relevant MeSH Terms

Breast Cancer