Clinical Trial 18649

Cancer Type: Breast
Interventions:FR alpha peptide vaccine; GM-CSF; Leukine (GM-CSF); cyclophosphamide; cytoxan (cyclophosphamide); sargramostatin (GM-CSF)

Study Type: Treatment
Phase of Study: Phase II


    Study Title

    A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination with Folate Receptor Alpha Peptides with GM-CSF in Patients with Triple Negative Breast Cancer Defined as Primary Tumor that is Her2-neu Negative and Low (< 10%) ER/PR Nuclear Staining.


    This study is being done to gather information. The study will provide important information related to the safety and the effect of the folate receptor vaccine on the immune system. What investigators learn from this study could possibly be used in the future to treat breast cancer or prevent or delay recurrence of breast cancers.


    Primary Objectives: To evaluate high and low dose hu-FR¨¢ peptide vaccine with GM-CSF administered every month for 6 months (the vaccination phase) to elicit a FR¨¢-specific T cell response. To evaluate cyclophosphamide priming prior to vaccinations to elicit a FR¨¢-specific T cell response. To evaluate the safety and tolerability of high and low dose hu-FR¨¢ peptide vaccine with GM-CSF. To evaluate the long term safety and tolerability of booster vaccination of hu-FR¨¢ peptide vaccine with GM-CSF. Secondary Objectives: To determine FR¨¢ expression status on primary tumors when available as formalin-fixed, paraffin-embedded material and whether expression correlates with the emergence of a FR¨¢ specific T cell response. To determine the relapse free survival of patients with TNBC after treatment with hu-FR¨¢ peptide vaccine with GM-CSF and determine whether the RFS correlated with the emergence of a FR¨¢ specific T cell response.

    Inclusion Criteria

  • Female patient, Age 18 years or older
  • Written informed consent
  • Primary tumor was negative for estrogen receptor (ER), Progestogen Receptor (PR) and negative for Human epidermal growth factor receptor 2 (Her2-neu) (0 or 1+ on immunohistochemistry and/or normal gene copy number by fluorescence in-situ hybridization)
  • Completed primary treatment (surgery and radio/chemotherapy in adjuvant or neo-adjuvant setting) less than 360 days prior to 1st vaccination.
  • Completed last cycle of chemotherapy or radiation > 60 days prior to 1st vaccination
  • Unilateral or bilateral primary carcinoma of the breast with tumor Stage II-III according to AJCC 7th edition, and one of the following: A) For participants treated in the neoadjuvant setting: Histologically detectable tumor residuals (excludes ypT0/is ypN0), M0 and no evidence of gross tumor or gross residual adenopathy. B) For participants treated in the adjuvant setting: pN2-3 and M0. No evidence of gross tumor or gross residual adenopathy.
  • Adequate Blood, renal and hepatic function, as determined within 28 days from enrollment

  • Exclusion Criteria

  • Clinical evidence of distant metastases per practice guidelines for breast cancer
  • Inflammatory breast cancer or tumor with deep adherence or cutaneous invasion
  • Known hypersensitivity reaction to the GM-CSF adjuvant; Any known contra-indication to GM-CSF or Cyclophosphamide treatment
  • Pregnant or lactating
  • History of auto-immune diseases
  • Other uncontrolled illness or medical condition , such as active infection, symptomatic heart failure, unstable angina pectoris, myocardial infarction or stroke within last 6 months, psychiatric illness that may limit compliance with study requirement or interfere with the understanding and giving of informed consent
  • Prior active secondary malignancy > Completed treatment with systemic corticosteroid or immune-modulators > 30 days prior to registration
  • Planned treatment with other experimental drugs or any other non-hormonal anti-cancer therapy
  • Immunocompromised, including patients known HIV infection
  • Currently receiving thyroid replacement therapy unless negative for thyroid antibodies (TSH receptor, TPO, thyroglobulin).