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Protocol Details

A Phase I/II Study of Adjuvant PRGN-2012 in Adult Patients with Recurrent Respiratory Papillomatosis

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

21-C-0013

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Children

Keywords

Human Papilloma Virus;
Dose excalation;
laryngotracheal disease;
papillomatous disease;
Avelumab

Recruitment Keyword(s)

None

Condition(s)

Recurrent Respiratory Papillomatosis;
Papillomavirus Infections;
Papillomaviridae

Investigational Drug(s)

PRGN-2012

Investigational Device(s)

None

Intervention(s)

Drug: PRGN-2012

Supporting Site

National Cancer Institute

Background:

Recurrent respiratory papillomatosis (RRP) is a rare disease. It is caused by the human papillomavirus (HPV). RRP affects the upper and lower respiratory tracts. It is difficult to treat and can be fatal. Researchers want to see if PRGN-2012 can help.

Objective:

To find a safe, tolerable dose of PRGN-2012 and to see if it works in treating RRP.

Eligibility:

Adults 18 and older who have RRP

Design:

Participants will be screened with a medical history and physical exam. They will have blood tests and viral studies. They may have a computed tomography (CT) scan of the neck and/or chest. The structures inside their nose, throat, larynx (voice box), and upper windpipe will be viewed using a small tube with a built-in camera (endoscope). Their arm veins will be evaluated. They will have a pregnancy test, if needed.

Screening tests will be repeated during the study.

Participants will have surgery. Their papilloma will be removed. They will have another surgery if it grows back. They will have to stay at the hospital for 1 to 2 days after each surgery.

Participants will complete questionnaires about how much RRP affects their voice.

Participants will get PRGN-2012 as an injection under the skin on days 1, 15, 43, and 85.

Participants may have optional leukapheresis.

Participants will have visits 6, 12, and 24 weeks after their last dose of PRGN-2012. These visits will assess the safety of PRGN-2012 and disease response to the treatment. After the 24-week visit, participants will be called every 3 months for 2 years.

Participation will last for up to 3 years.

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Eligibility

INCLUSION CRITERIA:

- Age 18 years and older

- Clinical diagnosis of RRP

--Histological diagnosis of papilloma confirmed by pathology report from a CLIA-certified laboratory

--Presence of laryngotracheal papillomas with or without pulmonary RRP

--A history of 2 or more interventions in the last 12 months for control of RRP

- Clinical performance status of ECOG of 0-1

- Willing to undergo endoscopic evaluation and operative interventions with biopsies in compliance with this protocol

- No systemic therapy for RRP for at least 3 half-lives of the prior drug(s). A 30-day washout is required for systemic bevacizumab treatment

- Participants who have received prior immunotherapy for RRP are permitted

- Participants must have adequate organ and marrow function as defined below:

WBC >2,000/mcL

absolute neutrophil count greater than or equal to 1,500/mcL

hemoglobin >9.0 g/dL

platelets greater than or equal to 100,000/mcL

total bilirubin within normal institutional limits

AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal creatinine within normal institutional limits

OR

creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal.

PT/INR and PTT less than or equal to upper limit of normal

- Participants sexually active subjects (men and women) of reproductive potential must agree to use two methods of contraception: one highly effective and one other effective method throughout vaccine treatment and for at least 120 days after vaccine treatment. Highly effective methods are defined as: Intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation and partner s vasectomy; other effective methods are defined as: latex condom, diaphragm and cervical cap.

- Seronegative for hepatitis B antigen, positive hepatitis B tests can be further evaluated by confirmatory tests (Hep B DNA quant, HBV viral load), and if confirmatory tests are negative, the participant can be enrolled.

- Seronegative for hepatitis C antibody unless antigen negative. If hepatitis C antibody test is positive, then participants must be tested for the presence of antigen by Hep C RNA quant, HCV viral load and be HCV RNA negative

- All participants must have the ability to understand and willingness to sign a written informed consent

EXCLUSION CRITERIA:

- A history of surgical debridement of papillomas such that in the opinion of the study team a participant is unlikely to be able to safely have a six-week interval between surgical interventions.

- History of significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (greater than or equal to New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.

- Any severe acute or chronic medical or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior, liver disease, lung disease (with the exception of what is specified in the inclusion criteria) , or laboratory abnormalities that, in the opinion of the investigators, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results and in the judgment of the investigator, would make the participant inappropriate for entry into this study. Participants with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) well controlled with oral or inhaled medications are permitted to enroll.

- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled, topical intranasal or intro-ocular steroids, and adrenal replacement doses <10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.

- Participants who are receiving any other investigational agents

- Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 5.0; however, alopecia, sensory neuropathy Grade less than or equal to 2 or other Grade less than or equal to 2 AEs not constituting a safety risk based on investigator's judgment are acceptable.

- Known alcohol or drug abuse.

- Participant, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

- History of allergy to study drug components.

- Pregnant women are excluded from this study because PRGN-2012 is an agent with unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with PRGN-2012, breastfeeding should be discontinued if the mother is treated with PRGN-2012. These potential risks may also apply to other agents used in this study.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Scott M. Norberg, D.O.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240
10 CENTER DR
BETHESDA MD 20892
(301) 275-9668
scott.norberg@nih.gov

Erin W. Ferraro, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 3-3330
10 Center Drive
Bethesda, Maryland 20814
(240) 760-6163
erin.ferraro@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04724980

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