Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors (Icotinib)

September 8, 2021 updated by: Li Peng

Icotinib Hydrochloride Tablets Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors

1)Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of Icotinib; 3)Provide an objective basis for an enlarged randomized double-blind trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neurofibromatosis type 2 (NF2) is a hereditary tumor predisposition syndrome caused by mutations in the NF2 tumor suppressor gene. Individuals with NF2 have a higher likelihood to develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas. The hallmark of NF2 is bilateral vestibular schwannomas. Historically, most NF2 patients experience complete hearing loss either from tumor progression or after treatment of the tumors with surgery or radiation. Effective treatments are urgently needed for NF2 patients with progressive hearing loss because hearing loss is associated with impairment in social, emotional,and communication function and with increased depression.

Previous studies of NF2 patients treated with Erlotinib suggested that inhibition of epidermal growth factor receptor (EGFR) could result in hearing improvement and reduction in tumor size.

Much evidence implicates human epidermal growth factor (HER) receptors in vestibular schwannoma growth.Some studies have demonstrated that Merlin, the NF2 gene protein product, controls surface availability of the EGFR, ErbB2, and ErbB3 receptors in human and Drosophila models. Besides, cell culture models of mouse embryo fibroblasts (MEFs) support the role of EGFR in NF2-associated tumorigenesis. Nf2-deficient cells in culture lack contact-dependent inhibition of growth and continue to grow in confluent cultures. This effect appears to be mediated by EGFR signaling. Treatment of Nf2-deficient cells with EGFR inhibitors such as gefitinib can restore contact-dependent inhibition, suggesting that this class of drugs might be useful for NF2 patients with progressive vestibular schwannomas. In this way, Icotinib can inhibit the nutrition of the tumor and decrease the tumor's growth and metastasis. Based on these studies, we perform this clinical trial to known the treatment effect and tolerability of Icotinib on NF2.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100050
        • Beijing Tiantan Hospital Affiliated to Capital Medical University
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Tiantan Hospital Affiliated to Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients must be at the age of 16-50
  2. Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors
  3. Patients must not be treated with other drugs or radiation therapy recently
  4. Patients should live in Beijing or nearby and can be treated in hospital
  5. Patients must be healthy and not be seriously allergic with biological agents
  6. Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent.

Exclusion Criteria:

  1. Treated with other drugs, surgery or radiation therapy recently
  2. Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time
  3. Being pregnant or try to get pregnant, lactating women
  4. With acute or chronic infectious diseases
  5. With heart diseases, cardiac dysfunction or abnormal ECG
  6. With uncontrolled neural or mental diseases, poor compliance
  7. Not available for enhanced MRI
  8. Take part in any other clinical trial
  9. With other conditions that are considered not suitable for this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Icotinib，treatment effect evaluation
Patients use Icotinib hydrochloride tablets during the course of treatment. The drug dosage is 125mg/m3/d. Every course of treatment lasts three months. Patients are designed to receive total four courses of treatment if there is no disease progression.
Drug: Icotinib
Method of drug administration:oral; Dosage: 125mg/m3/d; Course of treatment: 3 months;Total four treatment courses.
Other Names:
  • Icotinib Hydrochloride Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in volume of tumour after every course of the treatment
Time Frame: Baseline,Month 3,Month 6,Month 9,Month 12
Patients in this clinical trial would receive MRI test to evaluate the volume of tumour after every course of the treatment.
Baseline,Month 3,Month 6,Month 9,Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in hearing ability after every course of the treatment
Time Frame: Baseline,Month 3,Month 6,Month 9,Month 12
Patients' hearing ability would be tested after every course of the treatment.
Baseline,Month 3,Month 6,Month 9,Month 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in QOL(quality of life) score after every course of the treatment
Time Frame: Baseline,Month 3,Month 6,Month 9,Month 12
Patients' QOL(quality of life) would be evaluated after every course of the treatment.
Baseline,Month 3,Month 6,Month 9,Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Li Peng

Collaborators

Betta Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

July 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (ESTIMATE)

October 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tian-drug-neuro002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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