A Phase 1 Study Of The Safety And Immunogenicity Of Peptide-loaded Autologous Dendritic Cell Vaccination In Recurrent Respiratory Papillomatosis (RRP) Patients
The purpose of this study is to evaluate the safety and immunogenicity of autologous DC vaccine in recurrent respiratory papillomatosis patients
• Clinically confirmed diagnosis of recurrent respiratory papillomatosis.
• Patients with papillomas in the laryngeal mucosa at the time of recruitment and patients with records of recurrent papillomas in laryngeal mucosa at least once in the past 6-12 months at the time of recruitment. NOTE: The presence of papillomas in laryngeal mucosa or clinical records of the presence of papillomas in laryngeal mucosa is required.
• Human papilloma virus (HPV)6+ RRP in larynx
• ECOG (Eastern cooperative oncology group performance test) performance status 0 or 1 (Appendix I).
• The following laboratory values obtained ≤ 28 days prior to apheresis.
‣ Absolute neutrophil count (ANC) ≥1.0 x 109 /L
⁃ Platelet count (PLT) ≥ 75 x 109 /L
⁃ Hemoglobin ≥ 8.5 g/dL
⁃ Lymphocytes ≥ 0.3 x 109 /L
⁃ Total bilirubin ≤ 2 x upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then Direct bilirubin ≤1.0 mg/dL.
⁃ Aspartate transaminase (AST) ≤ 3 x ULN
⁃ Creatinine ≤ 2.0 mg/dL
⁃ Monocytes ≥ 0.25 x 109 /L
• Able to provide informed written consent.
• Willingness to return to Mayo Clinic Arizona for follow-up appointments
• Willingness to provide blood samples for immune assessment and other tests
• Willingness to provide papilloma tissues that will be surgically removed
• Agree that during the trial, male participants will not father a child and female participants cannot be or become pregnant if they are of child-bearing potential.
• Subjects must fulfill one of the following conditions:
‣ Agree to use one highly effective or combined contraceptive method that results in a failure rate of methods must always be supplemented with the use of spermicide.
⁃ Be surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females).
⁃ Be of non-childbearing potential (≥12 months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone \[FSH\], if not on hormone replacement).