Inflammatory Myofibroblastic Tumor Clinical Trial
Official title:
Targeted Therapy in Children and Adolescents With Recurrent, Progressive and Unresectable Inflammatory Myofibroblastic Tumor With the Inhibitor of Tyrosine Kinase -Crizotinib
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | March 1, 2021 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
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 fun?tion (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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology | Moscow |
Lead Sponsor | Collaborator |
---|---|
Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall response rate | The frequency of response to therapy with Crizotinib in patients with translocation of the ALK / ROS1 genes and their partners. | 2 months | |
Secondary | Relapse-free survival | Time after treatment without any signs or symptoms of inflammatory myofibroblastic tumor | 5 years | |
Secondary | Overall survival | The length of time from the start of treatment with crizotinib, that patients diagnosed with the inflammatory myofibroblastic tumor are still alive | 5 years |
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