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The Therapeutic Effect of Thalidomide in RI

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ClinicalTrials.gov Identifier: NCT03208413
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Tracking Information
First Submitted Date  ICMJE May 8, 2017
First Posted Date  ICMJE July 5, 2017
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE July 19, 2017
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
the brain injury remission [ Time Frame: Week 15 ]
The brain injury remission is defined as ≥ 25% reduction in brain edema volume on FLAIR images at week 15, as compared with that before thalidomide usage
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
  • Brain MRI scan [ Time Frame: Week 15 ]
    Brain edema volume evaluated by MRI
  • LENT/SOMA scales [ Time Frame: Week 15 ]
    neurological functions by LENT/SOMA scales
Change History Complete list of historical versions of study NCT03208413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • improvement of quality of life [ Time Frame: Week 15 ]
    the difference value of WHO-QOL scale before and after thalidomide regimen
  • improvement of neurological function [ Time Frame: Week 15 ]
    the difference value of LENT/SOMA scales before and after thalidomide regimen
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
The evaluation of quality of life [ Time Frame: Week 15 ]
WHO-QOL(quality of life) scales
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Therapeutic Effect of Thalidomide in RI
Official Title  ICMJE The Effect of Thalidomide in Radiation-induced Brain Injury(RI): a Phase II Clinical Trial
Brief Summary

Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in radiation-induced brain injury.

Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang.

Primary outcome measure: The primary endpoint is the brain injury remission at week 15. In brief, the brain lesion will be evaluated by using brain MRI scan before and after thalidomide regimen. The clinical efficacy is defined as ≥ 25% reduction in brain edema volume on FLAIR images at week 15, as compared with that before thalidomide usage.

Detailed Description

There is no acknowledged and effective standard treatment for radiation-induced brain injury (RI). Glucocorticoids and bevacizumab during acute period are optional ways to reduce the brain edema. However, glucocorticoids and bevacizumab are unsuitable or ineffective for some patients, especially in the early stage of RI. The investigators supposed that angiogenesis might play a key role in the pathogenesis of RI, and that thalidomide, as an antiangiogenic drug, would reduce immature angiogenesis and improve vessel maturation in RI.

Primary objectives: This phase II clinical trial aims to evaluate the indications, therapeutic effects and safety of thalidomide in radiation-induced brain injury.

OUTLINE: This is a phase II, open-label, single arm clinical trial. Patients are enrolled and administrated with thalidomide. Thalidomide is supplied as 25 mg per pill to be taken by mouth.

Arm І: Patients receive thalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Radiation Injuries
Intervention  ICMJE Drug: Thalidomide
Thalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration.
Study Arms  ICMJE Experimental: thalidomide
Thalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration.
Intervention: Drug: Thalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2017)
58
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2017)
64
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Prior irradiation >/= 12 months prior to study entry.
  • Radiographic evidence to support the diagnosis of radiation-induced brain injury without tumor recurrence.
  • Age>/= 35 years.
  • Contraindication to glucocorticoids and bevacizumab treatment due to history or high risk of severe adverse effects, or non-effective response to glucocorticoids and bevacizumab treatment in 12 months prior to study entry.
  • Estimated life expectancy must be greater than 12 months.
  • Routine laboratory studies: bilirubin </=1.0 * upper limits of normal (ULN); aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT)< 1.0 * ULN; creatinine <1.0 * ULN; white-cell count >/= 4,000 per cubic millimeter; neutrophils count >/=1500 per cubic millimeter platelets >/= 100,000 per cubic millimeter; Hb >/=110 gram per millilitres; PT, APTT, INR in a normal range.
  • Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document.

Exclusion Criteria

  • Evidence of tumor metastasis, recurrence, or invasion;
  • Current usage of bevacizumab;
  • Current usage of glucocorticoids;
  • Evidence of very high intracranial pressure that suggests brain hernia and need surgery;
  • History of psychiatric diseases before radiotherapy;
  • History of seizures;
  • History of arteriosclerotic cardiovascular diseases (ASCVD), e.g. stroke, myocardial infaction, unstable angina, within 6 months;
  • New York Heart Association Grade II or greater congestive heart failure;
  • Serious and inadequately controlled cardiac arrhythmia;
  • Significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, history of aortic dissection;
  • Severe infection;
  • History of allergy to relevant drugs;
  • Pregnancy, lactation, or fertility program in the following 12 months;
  • History or current diagnosis of peripheral nerve disease;
  • Abnormal in liver and renal function;
  • Active tuberculosis;
  • Transplanted organs;
  • Human immunodeficiency virus;
  • Participation in other experimental studies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yamei Tang, M.D., Ph.D. 86-13556001992 yameitang@hotmail.com
Contact: Yi Li, M.D., Ph.D. 86-15018761512 1024254327@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03208413
Other Study ID Numbers  ICMJE 2017001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Sponsor  ICMJE Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yamei Tang, M.D., Ph.D. Sun Yat-sen Memorial Hospital,Sun Yat-sen University
PRS Account Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP