Clinical Trials /

Vaccination of High Risk Breast Cancer Patients

NCT02229084

Description:

The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III estrogen-receptor (ER)-positive, HER2-negative breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Vaccination of High Risk Breast Cancer Patients
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 202556
  • NCT ID: NCT02229084

Conditions

  • Breast Cancer
  • Breast Neoplasms

Interventions

DrugSynonymsArms
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard neoadjuvant chemotherapyPart 1 - Chemovax Schedule A

Purpose

The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III estrogen-receptor (ER)-positive, HER2-negative breast cancer.

Detailed Description

      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, HER2-negative 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, HER2-negativebreast-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, HER2-negative breast cancer.
    

Trial Arms

NameTypeDescriptionInterventions
Part 1 - Chemovax Schedule AExperimentalFeasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG 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).
  • Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
Part 1 - Chemovax Schedule BExperimentalFeasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG 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).
  • Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
Part 1 - Chemovax Schedule CExperimentalFeasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG 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).
  • Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
Part 1 - Chemovax Schedule DExperimentalFeasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG 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).
  • Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
Part 1 - Chemovax Schedule EExperimentalFeasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG 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).
  • Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
Part 2 - Chemovax Schedule CExperimentalPrimary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG 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).
  • Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
Part 3 - Chemovax Schedule CExperimentalExpanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG 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).
  • Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)

Eligibility Criteria

        Inclusion Criteria:

          -  Females of all races with clinical stage I, II, or III ER-positive, HER2 negative
             breast cancer who will undergo SoC neoadjuvant treatment.

          -  Age 18 years and older.

          -  ECOG Performance Status 0 or 1.

          -  White blood cell (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration.

          -  Platelet count ≥ 100,000/mm3 within 3 weeks prior to registration.

          -  Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks
             prior to registration.

          -  Serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase test
             (AST) ≤ 2 x IUL of normal obtained within 3 weeks prior to registration.

          -  Serum glutamic-pyruvic transaminase (SGPT) or alanine aminotransferase test (ALT) ≤ 2
             x IUL of normal obtained within 3 weeks prior to registration.

          -  Serum creatinine ≤ 1.8 mg/dL obtained within 3 weeks prior to registration.

          -  Must sign an informed consent document approved by the UAMS IRB.

        Exclusion Criteria:

          -  ER-negative, HER2-positive, inflammatory, metastatic, stage IV or recurrent breast
             cancer

          -  Active infection requiring treatment with antibiotics.

          -  Existing diagnosis or history of organic brain syndrome that might preclude
             participation in the full protocol.

          -  Existing diagnosis or history of significant impairment of basal cognitive function
             that might preclude participation in the full protocol.

          -  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.

          -  Active autoimmune disorders or conditions of immunosuppression; Existing diagnosis or
             history of autoimmune disorders or conditions of immunosuppression that have been in
             remission for less than 6 months

          -  Treatment with corticosteroids, including oral steroids (i.e. prednisone,
             dexamethasone [except when used as an antiemetic in SoC 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 breastfeeding (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 starting week 1 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 tubal ligation, oral contraceptives, barrier
             methods, 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.

          -  Enrollment in any other clinical trial using investigational drug products or devices
             prior to first post-surgery study lab. Concurrent enrollment in observational studies
             is allowed.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Identify a feasible schedule of vaccination relative to SoC neoadjuvant chemotherapy when the Chemovax are administered concurrently.
Time Frame:At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)
Safety Issue:
Description:Number of participants with sufficiently high anti-P10s immunoglobulin-G response Feasibility will be evaluated in terms of Generation of a sufficiently high anti-P10s immunoglobulin-G response Safety and tolerability of the combination of vaccine and chemotherapy

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Arkansas

Trial Keywords

  • clinical stage I, II or III
  • ER postive
  • HER2 negative

Last Updated

April 6, 2021