Overview

Study of Crizotinib in Children and Adolescents With Myofibroblastic Tumors

Status:
Unknown status
Trial end date:
2021-03-01
Target enrollment:
0
Participant gender:
All
Summary
Targeted therapy based on target identification by genetic examinations is a promising direction in the treatment of patients with a complicated course of inflammatory myofibroblastic tumor. Recently, the main work covered in foreign publications, aimed at finding additional methods of treatment, by identifying new targets for targeted therapy in patients with unresectable IMT, but currently there is no standardized approach to the treatment of IMT in children worldwide. This study can show the benefits of the usage of crizotinib as targeted therapy in children with ALK/ROS1 positive unresectable, progressive or reccurent inflammatory myofibroblastic tumors. The main hypothesis is that crizotinib would increase an objective response rate in this group of patients.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Treatments:
Crizotinib
Criteria
Inclusion Criteria:

- Age 0 - 18 years

- The presence of a histologically verified diagnosis of Inflammatoru Myofibroblastic
Tumor, confirmed in the pathology laboratory of Dmitry Rogachev National Research
Center

- The presence of ttumor masses according to CT or MRI at the time of inclusion in the
protocol

- Unresectable or metastatic tumor

- Relapse or progressive disease

- Good perfomance status

- Normal function of bone marrow

- Normal function of a liver

- Normal levels of creatinine and urea in blood

- Nornal heart funсtion (LVEF > 60%)

- Clear expression of rearranged ALK/ROS1 genes

- Signed Informed Consent

Exclusion Criteria:

- Age >18 years

- Refusal of signing the form of the informed consent

- The presence of comorbidities, which may endanger patient safety

- No rearrangements of ALK/ROS genes

- No signs of existing tumor, according to CT and MRI