Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05797246
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • DNA Virus Infections
  • Disease Attributes
  • Infections
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms, Glandular and Epithelial
  • Neoplasms, Squamous Cell
  • Papilloma
  • Papillomavirus Infections
  • Pathologic Processes
  • Recurrence
  • Respiratory Tract Diseases
  • Respiratory Tract Infections
  • Tumor Virus Infections
  • Virus Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    10 mg/kg IV every three weeks for 3 cycles and then every 6 weeks for a total treatment course of 11 cycles for approximately 1 year total.

Study Details

Background: Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths in the airways. These growths come back when removed; some people may need 2 or more surgeries per year to keep their airways clear. Better treatments are needed. Objective: To see if a drug called bevacizumab can reduce the number of surgeries needed in people with RRP. Eligibility: People aged 18 and older with recurrent RRP; they must need surgery to remove the growths in their airways. Design: Participants will be screened. Their ability to breathe and speak will be evaluated. They will have an endoscopy: a flexible tube with a light and camera will be inserted into their nose and throat. They will have a test of their heart function and imaging scans of their chest. Participants will have surgery to remove the growths in their airways. Bevacizumab is given through a small tube placed in a vein in the arm. After the surgery, participants will receive 11 doses of this drug: every 3 weeks for 3 doses, and then every 6 weeks for 8 more doses. They will come to the clinic for each dose; each visit will be about 8 hours. Tissue samples of the growths will be collected after the second treatment; this will be done under general anesthesia. Participants may undergo apheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the cells needed for the study. The remaining blood will be returned to the body through a second needle. Follow-up will continue for 1 year after the last treatment.

Key Dates

First listed
Apr 4, 2023
Start date
Aug 2, 2023
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jan 1, 2029

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Bevacizumab treatment course

Primary Outcome Measure

To determine the percentage of participants with an increase in their surgery-free interval during treatment with systemic bevacizumab. [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center· Bethesda, MD

Related Studies