Study of Crizotinib in Children and Adolescents With Myofibroblastic Tumors

NCT03874273 | Unknown Phase 2

• 1 other identifier: NCPHOI-2019-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Inflammatory Myofibroblastic Tumor

Keywords

inflammatory myofibroblastic tumor; crizotinib; Paediatric oncology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Relapse-free survival

  5 years

• Overall survival

  5 years

Study Arms (1)

crizotinib +

EXPERIMENTAL

Patients with unresectable, relapsed or refractory inflammatory myofibroblastic tumor, receiving crizotinib

Drug: Crizotinib

Interventions

Crizotinib DRUG

Crizotinib 280mg/m2 twice a day (for 24 months maximum)

Also known as: Xalkori

crizotinib +

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: lead

Study Sites (1)

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

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Granuloma, Plasma Cell

Interventions

Crizotinib

Condition Hierarchy (Ancestors)

Granuloma; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)