Autologous Dendritic Cell Vaccine For Recurrent Respiratory Papillomatosis (RRP) Patients
ConditionRecurrent Respiratory Papillomatosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to evaluate the safety and immunogenicity of autologous DC vaccine in recurrent respiratory papillomatosis patients
Eligibility criteria
Qualifiers
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).
Disqualifiers
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Receiving any other approved or investigational agent (including immune checkpoint blockers, immune modulators, and therapeutic vaccine models) for recurrent respiratory papillomatosis patients which would be considered as a treatment for the papillomas in laryngeal mucosa ≤ 6 months prior to study enrollment.
Trial design
Treatments tested in this trial
- Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell
Treatment groups
9 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov