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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Radiation Injuries Drug: Thalidomide Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Thalidomide in Radiation-induced Brain Injury（RI）: a Phase II Clinical Trial
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide

Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. improvement of quality of life [ Time Frame: Week 15 ]
    the difference value of WHO-QOL scale before and after thalidomide regimen

  2. improvement of neurological function [ Time Frame: Week 15 ]
    the difference value of LENT/SOMA scales before and after thalidomide regimen


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208413


Contacts
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Contact: Yamei Tang, M.D., Ph.D. 86-13556001992 yameitang@hotmail.com
Contact: Yi Li, M.D., Ph.D. 86-15018761512 1024254327@qq.com

Locations
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China, Guangdong
Cancer canter of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Mingyuan Chen, M.D., Ph.D.    86-15692015027    406143748@qq.com   
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Yamei Tang, M.D., Ph.D.    86-13556001992    yameitang@hotmail.com   
Sub-Investigator: Yi Li, M.D., Ph.D.         
Guangzhou Huiai Hospital Recruiting
Guanzhou, Guangdong, China, 510000
Contact: Dong Zheng       920905565@qq.com   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Study Director: Yamei Tang, M.D., Ph.D. Sun Yat-sen Memorial Hospital,Sun Yat-sen University
More Information
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Responsible Party: Yamei Tang, Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03208413    
Other Study ID Numbers: 2017001
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
thalidomide
radiation-induced brain injury
Additional relevant MeSH terms:
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Radiation Injuries
Wounds and Injuries
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
 Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents