Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell

    Biological/Vaccine

    Each patient will receive 5 doses autologous immunotherapy intradermally.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: Disease GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events

Safety will be assessed as number of participants to experience adverse events, including systemic symptoms, irritation, inflammation, and any adverse events identified through physical exam and blood counts.

Time frame
20 months

Secondary outcomes

1

Papilloma Resolution

To evaluate the absence of laryngeal papilloma the number of laryngeal papilloma at completion of the treatment will be measured. This measurement will be compared to 3-year baseline data, or shorter based on date of diagnosis, for each patient as a self-control to interpret time and severity of recurrence.

Time frame
20 months
2

Time to Disease Recurrence

To measure time to disease recurrence of patients treated with autologous immunotherapy, the number of laryngeal papilloma during the treatment will be measured. This measurement will be compared to 3-year baseline data, or shorter based on date of diagnosis, for each patient as a self-control to interpret time and severity of recurrence.

Time frame
20 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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