ACTIVE_NOT_RECRUITING

Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)

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Conditions

Respiratory Tract DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Squamous CellTumor Virus InfectionsInfectionsVirus DiseasesDNA Virus InfectionsPathologic ProcessesDisease AttributesRecurrencePapillomaRespiratory Tract InfectionsPapillomavirus InfectionsHuman Papilloma VirusDose Escalationlaryngotracheal diseasepapillomatous disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Study of Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)

Quick Facts

Study Start:2023-08-02
Study Completion:2029-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05797246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 years old.
  2. * Histologically confirmed diagnosis of RRP.
  3. * Individuals must require procedure(s) to remove papillomatous disease per standard of care.(not required for re-treatment)
  4. * A history of 2 or more surgeries within 12 months prior to treatment initiation in order to control laryngeal and/or tracheal RRP (not required for re-treatment).
  5. * At least one of the following (not required for re-treatment):
  6. * A Derkay score of 8 or greater
  7. * Measurable disease per RECIST 1.1 (participants with pulmonary RRP only)
  8. * Tracheal involvement with RRP that has required two or more clinical interventions in the last 12 months (two or more clinical interventions)
  9. * Tracheostomy.
  10. * ECOG performance status of 0-1.
  11. * Individuals must have adequate organ and marrow function as defined below:
  12. * White blood cells (WBC): \>2,000/microL
  13. * Absolute neutrophil count (ANC): \>=1,500/microL
  14. * Hemoglobin: \>9.0 g/dL
  15. * Platelets: \>=100,000/microL
  16. * Total bilirubin: \<=1.5 mg/dL, except in participants with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg/dL
  17. * Aspartate aminotransferase (AST) /Alanine aminotransferase (ALT): \<=2.5 X institutional upper limit of normal (ULN)
  18. * Creatinine: within normal institutional limits
  19. * Prothrombin time (PT) /International normalized ratio (INR) and Partial thromboplastin time (PTT): \<=1 X institutional ULN. In participants on anticoagulation, coagulation tests should be within a therapeutic range.
  20. * Urinalysis: Urine dipstick \< 2+ proteinuria. In participants with \>=2+ proteinuria on dipstick urinalysis should undergo a 24-hour urine collection and must demonstrate \<=1g of protein in 24 hours to be eligible
  21. * Individuals must have received their last systemic therapy for RRP \> 4 weeks or 5 half-lives, whichever is longer, prior to treatment initiation, except for systemic bevacizumab which must be \> 1 year prior to treatment initiation (not applicable for re-treatment)
  22. * Individuals able to become pregnant and their partners must agree to use highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization ) for the duration of bevacizumab treatment and up to 6 months after completion of bevacizumab treatment. NOTE: Abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the individual is also acceptable.
  23. * Breastfeeding individuals must be willing to discontinue breastfeeding from study treatment initiation through 6 months after bevacizumab treatment discontinuation.
  24. * All individuals must have the ability to understand and willingness to sign a written informed consent.
  25. * All individuals must be willing to undergo mandatory biopsy during the study (not applicable for re-treatment).
  1. * History of significant (i.e., active) cardiovascular disease or thromboembolic event: cerebral vascular accident/stroke (within 6 months prior to treatment initiation), myocardial infarction (within 6 months prior to treatment initiation), unstable angina, congestive heart failure (\>= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication as assessed by EKG.
  2. * History of abdominal fistula or gastrointestinal perforation within 6 months prior to treatment initiation.
  3. * Major surgery within 4 weeks prior to treatment initiation.
  4. * Non-healing wound, active ulcer, or untreated bone fracture.
  5. * History of hemoptysis (\>2.5 mL of bright red blood per episode) within 1 month prior to treatment initiation.
  6. * Evidence of bleeding diathesis or significant coagulopathy (with or without current therapeutic anticoagulation).
  7. * Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to treatment initiation.
  8. * Inadequately controlled hypertension (defined as systolic blood pressure (BP) \>150 mmHg and/or diastolic blood pressure \> 100 mmHg), an average of 3 BP readings on 2 sessions will be used to measure blood pressure if initial reading indicates inadequately controlled hypertension. NOTE: Anti-hypertensive therapy to achieve blood pressures below these parameters is allowed.
  9. * Prior history of hypertensive crisis or hypertensive encephalopathy.
  10. * Persisting toxicity related to prior therapy of Grade \>1 per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. NOTE: alopecia, sensory neuropathy Grade \<=2 are acceptable.
  11. * Known active alcohol or drug abuse.
  12. * History of allergy to study drug components.
  13. * Pregnancy (confirmed with Beta-Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in WOCBP performed at screening).
  14. * Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.

Contacts and Locations

Principal Investigator

Scott M Norberg, D.O.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Scott M Norberg, D.O., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-02
Study Completion Date2029-01-01

Study Record Updates

Study Start Date2023-08-02
Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

  • Human Papilloma Virus
  • Dose Escalation
  • laryngotracheal disease
  • papillomatous disease

Additional Relevant MeSH Terms

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