Symptoms and General Pathology

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Rare Diseases

Recurrence

Disease Progression

Communicable Diseases

Respiratory Tract Infections

Papillomavirus Infections

Papilloma

Disease Attributes

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Recurrent Respiratory Papillomatosis

All Drugs and Chemicals

Vaccines

Immunologic Factors

There are 9 participants currently being followed in the faculty sponsor's clinic that carry the clinical and histologic diagnosis of RRP. The 9 participants meet one or more of the following criteria: Surgery requirement of more than 4 procedures per year, distal multisite spread of disease, and rapid regrowth of papilloma disease with airway compromise.

0.5 mL of quadrivalent HPV vaccine will be given intramuscularly at three separate intervals. Dose 2 is given 2 weeks after dose 1 and dose 3 is given 4 weeks after dose 1 for a total of 3 doses over 2 months.

Human Papillomavirus Vaccine

Troy D Scheidt, MD

The purpose of this study is to determine if administration of the HPV quadrivalent vaccine in patients diagnosed with RRP has a therapeutic effect on their clinical course. More specifically, does administration of the vaccine decrease the size and number of papillomas, severity of disease (i.e. hoarseness, inspiratory vs. biphasic stridor, airway obstruction) using the LCAS and time interval between required surgical debulking will be analyzed.

Patients who carry the diagnosis of Recurrent Respiratory Papillomatosis (RRP) will be asked to participate in the study. These patients have been followed by the faculty investigator for several years. Their disease state requires frequent interventions aimed at decreasing the severity and symptomatology of their vocal fold papillomas. Patients will be given the human papillomavirus quadrivalent vaccine and their clinical course will be followed over the next 6 months. Patients will have a laryngoscopic examination prior to treatment to establish their baseline disease state. They will have repeat laryngoscopic examinations at the time of the first, second and third vaccine injections, which will be given 1 month intervals for a total of 3 doses. They will have physical exam and laryngoscopic examinations at 1 month intervals for the first 6 months after administration of the vaccine. The severity of their clinical disease will be objectively measured using a validated scale for RRP assessment, the Laryngoscopic and Clinical Assessment Scale (LCAS).

Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis

Investigator Initiated Study of Effects of Progression of Recurrent Respiratory Papillomatosis in Patients After They Are Given Human Papillomavirus Quadrivalent Vaccine

University of Missouri-Columbia

Laryngeal Papillomatosis

biopsy

Pavinee Intakorn, MD

The purpose of the present study was to identify risk factors for more severe juvenile Recurrent Respiratory Papillomatosis (RRP) through prospective evaluation of a pediatric population in Thailand by the employing a protocol that includes staging of disease severity using above mentioned staging system at the time of each endoscopic debridement, as well as human papilloma virus (HPV) genotyping.

Recurrent respiratory papillomatosis is caused by human papilloma virus and is the most common benign laryngeal neoplasm in children. Although RRP is rarely fatal, the disease requires prolonged, extensive medical and surgical treatment, and causes physical and emotional suffering in affected children and their families. Although recurrent respiratory papillomatosis is a relatively unusual problem, it accounts for significant health are expenditures.The goal of management of RRP is control of the disease, preservation of the voice and prevention of major complication .The purpose of study will identify risk factors for more severe juvenile RRP through prospective evaluation of a pediatric population in Thailand by the employing a protocol that includes staging of disease severity , as well as HPV genotyping.

Objective:

* To identify the genotypes of HPV isolated from Thai RRP patients
* To compare staging and severity with HPV genotypes
* To correlate the following characteristics of the Thai RRP patients with the HPV genotypes

Papillomatous tissue samples taken from endoscopic biopsies will be collected by the ENT specialists.Samples collected from the subjects will be analyzed for HPV genotype at the Unit of virology and molecular, Department of pathology, Faculty of medicine Ramathibodi hospital.

Human Papillomatosis Genotyping of Children in Thailand

Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand

Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy

We compared disease severity(Cotreta-Derkay score) between groups of children with two different HPV genotypes

Coltera and Derkay have evolved a staging system to stage recurrent papillomatous lesions involving the respiratory tract.

Coltera-Derkay method of staging :

Clinical score:

1. Voice: Normal - 0, Abnormal - 1, Aphonia - 2
2. Stridor: Absent - 0, Present on activity - 1, Present at rest - 2
3. Respiratory distress - None - 0, Mild - 1, Moderate - 2, Severe - 3, Extreme - 4.

Anatomical score:

For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.

Total score = Anatomical score + Total clinical score

Merck Sharp & Dohme LLC

Queen Sirikit National Institute of Child Health

department of otorhinolarngology

Since this is the observational study, therefore the study process did not pose any risk to the participants (population at risk = 0)

Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy

Children With Recurrent Respiratory Papillomatosis

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Children With Recurrent Respiratory Papillomatosis in Thailand

The number of patients participating in this study was low , so additional studies should be conducted to make the research more effective.

Dr.Pavinee Intakorn

HPV type 6

HPV type 11

We found positive HPV DNA in all children. HPV type 6 and HPV type 11 caused recurrent respiratory papillomatosis in 6 (40%) and 9(60%) of cases,respectively.

Human Papillomavirus Genotypes

Children with recurrent respiratory papillomatosis from HPV 6

HPV 6

Children with recurrent respiratory papillomatosis from HPV 11

HPV 11

Cotreta-Derkay Score

Overall Study

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg

Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.

Adults: 400 mg celebrex (celecoxib) daily Pediatrics: 100 mg celebrex (celecoxib) daily for weight between 12-25 kg or 200 mg Celebrex (celecoxib) daily for weight \>25 kg

celebrex (celecoxib)

similar appearing capsules containing inert ingredients

placebo

Bettie M Steinberg, PhD

This is a randomized double blind controlled study to determine if celebrex (celecoxib), a selective COX-2 inhibitor, can decrease the rate of recurrence in adult and pediatric patients with recurrent respiratory papillomatosis. All patients will be evaluated for disease severity at enrollment and at 3 month intervals for 30 months. After randomization, patients in the early treatment arm will begin celecoxib 6 months after enrollment. The delayed treatment arm will begin celecoxib 18 months after enrollment. All patients will receive celecoxib for 1 year. During the time that patients do not receive celecoxib, they will receive a placebo capsule with the same appearance. Follow-up visits will occur at three month intervals for the duration of the study.

This is a randomized double blind placebo-controlled study,with plans to include 5 additional U.S. centers in the near future. The primary goal of this study is to determine whether celecoxib has efficacy in elimination or reduction of recurrent disease in patients with RRP. Our secondary goals are to determine whether continued celecoxib is required to maintain response, to correlate response with select patient demographics and with plasma levels of celecoxib. The study design encompasses a 30-month period, which can be divided into three segments:

Segment A: This is a 6 month run-in period in which all patients are assessed by direct laryngoscopy/bronchoscopy for disease severity, to permit growth rate stabilization and confirm accuracy of training of participating physicians. Patients will be treated by conventional surgery at three months and six months after enrollment.

Segment B: Patients begin 12 months of 400mg(adults), 100 mg (pediatric weight between 12 and 25 kg)or 200 mg (pediatric weight \> 25kg) celecoxib daily or placebo treatment in addition to surgical removal of all papillomas at each 3 month interval. This segment directly tests the hypothesis that celecoxib is an efficacious treatment for moderate to severe RRP and forms the basis for the primary statistical analyses.

Segment C: The primary purpose of this segment is to determine whether gains made during celecoxib therapy are maintained after it is discontinued, or whether celecoxib will need to be taken indefinitely. This will be determined by a 12 month period on placebo after cessation of celecoxib for the early treatment group. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C. However, the placebo first group was given celecoxib so that they could gain any possible benefits equivalent to those that received the celecoxib first.

Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis

A Multicentered Randomized Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis

Change in mean growth rates during the last 3 months of the first treatment period compared to the mean values at baseline. Endoscopy and removal of all tumor was done every 3 months. Growth rate is calculated as the scored amount of papilloma recurrence in a 3 month period divided by the exact number of days since last endoscopy and removal of all tumor.

Percent of patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline

Percent of patients of each gender with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline

Percent of juvenile versus adult onset patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.

Percent of patients with HPV 6 versus patients with HPV 11 with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.

Mean plasma levels of celecoxib over months 3-12 in first treatment period correlated with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline.

Percent of patients who responded to celecoxib with increase in papilloma growth rate of no greater than 0.01 at end of second treatment period compared to growth rate at end of first treatment period.

National Institute on Deafness and Other Communication Disorders (NIDCD)

University of Iowa

Eastern Virginia Medical School

University of Alabama at Birmingham

University of California, San Francisco

Vanderbilt University

Sanford Health

Weill Medical College of Cornell University

Northwell Health

Patients who received celecoxib for 12 months during either time period

Patients who received placebo for 12 months during either time period

Placebo

Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg

celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg

Celecoxib First, Then Placebo

Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.

celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg

Placebo First, Then Celecoxib

Total

Age < 20

Age 20 - < 40

Age 40 and above

Age, Customized

Ethnicity (NIH/OMB)

Rare prevalence of moderate to severe recurrent respiratory papillomatosis (estimated at 1:1million) limited enrollment

Dr. Bettie Steinberg

Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg

celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg

Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.

celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg

All patients in each arm who completed the first 1 year treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.

Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline

Celecoxib First (12 Months), Then Placebo (12 Months)

Placebo First (12 Months), Then Celecoxib (12 Months)

All patients that completed first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.

Percent of Patients With Positive Response to Treatment

Males treated with celecoxib during the first treatment period

Celecoxib First - Males

Males treated with placebo during the first treatment period

Placebo First- Males

Females treated with celecoxib during the first treatment period

Celecoxib First- Females

Females treated with placebo during the first treatment period

Placebo First- Females

All patients who completed first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.

Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%.

Juvenile-onset subjects treated with celecoxib during the first treatment period

Celecoxib First- Juvenile Onset

Juvenile-onset subjects treated with placebo during first treatment period

Placebo First- Juvenile-onsent

Adult-onset subjects treated with celecoxib during the first treatment period

Celecoxib First - Adult Onset

Adult-onset subjects treated with placebo during the first treatment

Placebo First- Adult-onset

Analysis conducted on all patients who completed first treatment period. Juvenile onset is defined as \<18 years of age at time of diagnosis. Age of disease onset for 2 patients was not available. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.

Effect of Juvenile Versus Adult Disease Onset on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%.

Subjects infected with HPV 6 treated with celecoxib during the first treatment period

Celecoxib First - HPV 6

Subjects infected with HPV 6 treated with placebo during first treatment period

Placebo First- HPV 6

Subjects infected with HPV 11 treated with celecoxib during the first treatment period

Celecoxib First- HPV 11

Subjects infected with HPV 11 treated with placebo during the first treatment period

Placebo First- HPV 11

Analysis conducted on all patients with HPV 6 or 11 infection who completed first treatment period. One patient with both HPV 6 and 11 and one patient with neither 6 or 11 were excluded. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.

Effect of HPV 6 Versus HPV 11 on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%

Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period relative to mean disease severity prior to treatment.

Responders

Subjects randomized to celecoxib first with response less than 50% at end of first treatment period relative to mean disease severity prior to treatment.

Non-responders

All patients who were randomized to receive celecoxib first and completed the first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C.

Correlation Between Mean Plasma Level of Celecoxib and Response.

Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period that maintained response at end of second treatment.

Celecoxib Responders-maintained

Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period whose papilloma growth rate worsened by more than 0.01 at end of second treatment period.

Celecoxib Responders- Not Maintained

All patients with complete response to celecoxib in first treatment period who completed the second treatment period where they received placebo. Because the number of responders was so small, no statistical analysis was performed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis	NCT00829608	Recurrent Respi...	Human Papilloma...	18 Years - 80 Years	University of Missouri-Columbia
Human Papillomatosis Genotyping of Children in Thailand	NCT01304966	Recurrent Laryn... Human Papilloma...	biopsy	- 18 Years	Queen Sirikit National Institute of Child Health
Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis	NCT00571701	Recurrent Respi...	celebrex (celec... placebo	2 Years -	Northwell Health
Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis	NCT00571701	Recurrent Respi...	celebrex (celec... placebo	2 Years -	Northwell Health
Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis	NCT00829608	Recurrent Respi...	Human Papilloma...	18 Years - 80 Years	University of Missouri-Columbia

Spots Global Cancer Trial Database for rrp

Every month we try and update this database with for rrp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rrp

Every month we try and update this database with for rrp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rrp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.