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The Therapeutic Effect of Thalidomide in RI

Primary Purpose

Radiation Injuries

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation Injuries focused on measuring thalidomide, radiation-induced brain injury

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer canter of Sun Yat-sen UniversityRecruiting
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityRecruiting
  • Guangzhou Huiai HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thalidomide

Arm Description

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.

Outcomes

Primary Outcome Measures

the brain injury remission
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

improvement of quality of life
the difference value of WHO-QOL scale before and after thalidomide regimen
improvement of neurological function
the difference value of LENT/SOMA scales before and after thalidomide regimen

Full Information

First Posted
May 8, 2017
Last Updated
November 21, 2019
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03208413
Brief Title
The Therapeutic Effect of Thalidomide in RI
Official Title
The Effect of Thalidomide in Radiation-induced Brain Injury（RI）: a Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Injuries
Keywords
thalidomide, radiation-induced brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
thalidomide
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
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.
Primary Outcome Measure Information:
Title
the brain injury remission
Description
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
Time Frame
Week 15
Secondary Outcome Measure Information:
Title
improvement of quality of life
Description
the difference value of WHO-QOL scale before and after thalidomide regimen
Time Frame
Week 15
Title
improvement of neurological function
Description
the difference value of LENT/SOMA scales before and after thalidomide regimen
Time Frame
Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yamei Tang, M.D., Ph.D.
Phone
86-13556001992
Email
yameitang@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Li, M.D., Ph.D.
Phone
86-15018761512
Email
1024254327@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yamei Tang, M.D., Ph.D.
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Cancer canter of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingyuan Chen, M.D., Ph.D.
Phone
86-15692015027
Email
406143748@qq.com
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamei Tang, M.D., Ph.D.
Phone
86-13556001992
Email
yameitang@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yi Li, M.D., Ph.D.
Facility Name
Guangzhou Huiai Hospital
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Zheng
Email
920905565@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Therapeutic Effect of Thalidomide in RI

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