Autologous Dendritic Cell Vaccine For Recurrent Respiratory Papillomatosis (RRP) Patients
United States9 participantsStarted 2026-04
Plain-language summary
The purpose of this study is to evaluate the safety and immunogenicity of autologous DC vaccine in recurrent respiratory papillomatosis patients
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
*…
What they're measuring
1
Number of participants with treatment-related adverse events