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Vaccination of High Risk Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT02229084
Recruitment Status : Enrolling by invitation
First Posted : August 29, 2014
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:

The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER)-positive breast cancer.

This is a single-arm, multi-site Phase I/II study designed with the two goals being (1) to evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with neoadjuvant chemotherapy and (2) to determine if the polymerase chain reaction (pCR) rate among ER-positive breast-cancer patients treated with the combination is significantly higher than the 8% rate observed among ER-positive breast-cancer subjects in a pooled analysis of seven randomized clinical trials. P10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant will be given in combination with neoadjuvant chemotherapy in female patients with clinical stage I, II or III ER-positive breast cancer.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Biological: Chemovax Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Combined Phase I/II Feasibility-and-Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG Combined With Neoadjuvant Chemotherapy
Study Start Date : January 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Chemovax Schedule A
Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Biological: Chemovax
Timing of the vaccination relative to chemotherapy
Other Names:
  • P10s-PADRE with standard chemotherapy
  • P10s-PADRE with MONTANIDE™ ISA 51 VG
  • P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapy

Active Comparator: Chemovax Schedule B
Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
Biological: Chemovax
Timing of the vaccination relative to chemotherapy
Other Names:
  • P10s-PADRE with standard chemotherapy
  • P10s-PADRE with MONTANIDE™ ISA 51 VG
  • P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapy

Active Comparator: Chemovax Schedule C
Chemovax Schedule C: Subjects will receive three weekly injections of vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
Biological: Chemovax
Timing of the vaccination relative to chemotherapy
Other Names:
  • P10s-PADRE with standard chemotherapy
  • P10s-PADRE with MONTANIDE™ ISA 51 VG
  • P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapy

Active Comparator: Chemovax Schedule D
Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
Biological: Chemovax
Timing of the vaccination relative to chemotherapy
Other Names:
  • P10s-PADRE with standard chemotherapy
  • P10s-PADRE with MONTANIDE™ ISA 51 VG
  • P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapy

Active Comparator: Chemovax Schedule E
Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
Biological: Chemovax
Timing of the vaccination relative to chemotherapy
Other Names:
  • P10s-PADRE with standard chemotherapy
  • P10s-PADRE with MONTANIDE™ ISA 51 VG
  • P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapy




Primary Outcome Measures :
  1. Number of participants with sufficiently high anti-P10s immunoglobulin-G response [ Time Frame: Week 64 +/- 4 weeks per subject ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females of all races with clinical stage I, II, or III ER-positive breast cancer who qualify for standard neoadjuvant treatment
  • Age 18 years and older
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • White blood cell (WBC) count ≥ 3,000/mm3 within 2 weeks prior to registration.
  • Platelet count ≥ 100,000/mm3 within 2 weeks prior to registration.
  • Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2 x institutional upper limit (IUL) of normal obtained within 2 weeks prior to registration.
  • Aspartate aminotransferase test (AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 2 weeks prior to registration.
  • Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 2 weeks prior to registration.
  • Serum creatinine ≤ 1.8 mg/dl obtained within 2 weeks prior to registration.
  • Must sign an informed consent approved by the University of Arkansas for Medical Sciences (UAMS) Institutional Review Board (IRB).

Exclusion Criteria:

  • Active infection requiring treatment with antibiotics.
  • Diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol.
  • Diagnosis or evidence of significant impairment of basal cognitive function that might preclude participation in the full protocol.
  • No other current malignancies. Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration.
  • Autoimmune disorders or conditions of immunosuppression. This includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when used as an antiemetic in standard therapy]), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed.
  • Pregnancy or breast feeding (due to the unknown effects of peptide/mimotope vaccines on a fetus or infant). Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study drug and must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. Accepted methods of contraception include oral contraceptives, barrier methods, Intrauterine Device (IUDs), and abstinence.
  • Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen.

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): NCT02229084


Locations
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United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Angela Pennisi, MD University of Arkansas

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02229084     History of Changes
Other Study ID Numbers: 202556
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vaccines
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic