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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
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.