Status:
UNKNOWN
Study of Crizotinib in Children and Adolescents With Myofibroblastic Tumors
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Inflammatory Myofibroblastic Tumor
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
PHASE3
Brief 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,...
Detailed Description
Inflammatory myofibroblastic tumor (IMT) is a rare type of childhood neoplasm characterized by intermediate biological behavior. The main method of treatment of this tumor is a complete surgical remov...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03874273
Start Date
February 1 2019
End Date
March 1 2021
Last Update
March 14 2019
Active Locations (1)
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1
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, Russia