Actively Recruiting
Efficacy and Safety of Sirolimus in Children and Adolescents With Juvenile Nasopharyngeal Angiofibroma (JNA)
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2022-09-22
117
Participants Needed
1
Research Sites
395 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Juvenile nasopharyngeal angiofibroma (JNA) is a pathologically benign yet locally aggressive and destructive tumor that develops in the choana and nasopharynx. Historical treatment of JNA has included embolization, surgical resection, and radiation. mTOR signaling way demonstrated to be involved in regulation of growth and angiogenesis of JNA. Sirolimus, as mTOR inhibitor, is a potential target JNA therapy. The main purpose of the study is to evaluate the efficacy and safety of sirolimus in children and adolescents with primary or recurrent JNA. Efficacy will be estimated based on dynamics of the JNA progression. Historical control group will be used for comparison as standard therapy. Due to limited experience of sirolimus in JNA in routine practice, study should be conducted in 2 phases: pilot and extended. Decision regarding extended phase will be based on the results of pilot phase.
CONDITIONS
Official Title
Efficacy and Safety of Sirolimus in Children and Adolescents With Juvenile Nasopharyngeal Angiofibroma (JNA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of juvenile nasopharyngeal angiofibroma (JNA)
- Male gender
- Age between 7 and 18 years
- Signed informed consent by parents or legal representative for those under 14, and by patient and parents for ages 14 to 18
- Adequate liver and kidney function
- Patients with primary JNA
- Tumor volume greater than 35 ml by MRI
- Patients with recurrent JNA after primary surgery who have not received sirolimus treatment before
You will not qualify if you...
- Allergy or hypersensitivity to sirolimus or similar drugs
- Presence of acute or chronic infections, including opportunistic infections
- Liver or kidney failure
- Need for medications that strongly affect the cytochrome CYP3A4 system (e.g., rifampicin, rifabutin, ketoconazole)
- Previous treatment with sirolimus or other mTOR inhibitors
- Conditions requiring palliative therapy as judged by the investigator
- Participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Institute of Pediatric Hematology, Oncology and Immunology
Moscow, Russia, 117997
Actively Recruiting
Research Team
I
Igor m Vorozhtsov, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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