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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Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

Moscow, Russia