NCT03208413

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2017

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

July 19, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

2.5 years

First QC Date

May 8, 2017

Last Update Submit

November 21, 2019

Conditions

Radiation Injuries

Keywords

thalidomideradiation-induced brain injury

Outcome Measures

Primary Outcomes (1)

  • 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

    Week 15

Secondary Outcomes (2)

  • improvement of quality of life

    Week 15

  • improvement of neurological function

    Week 15

Study Arms (1)

thalidomide

EXPERIMENTAL

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

Interventions

ThalidomideDRUG

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.

thalidomide

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cancer canter of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Guangzhou Huiai Hospital

Guanzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

  • Cheng J, Jiang J, He B, Lin WJ, Li Y, Duan J, Li H, Huang X, Cai J, Xie J, Zhang Z, Yang Y, Xu Y, Hu X, Wu M, Zhuo X, Liu Q, Shi Z, Yu P, Rong X, Ye X, Saw PE, Wu LJ, Simone CB 2nd, Chua MLK, Mai HQ, Tang Y. A phase 2 study of thalidomide for the treatment of radiation-induced blood-brain barrier injury. Sci Transl Med. 2023 Feb 22;15(684):eabm6543. doi: 10.1126/scitranslmed.abm6543. Epub 2023 Feb 22.

    PMID: 36812346DERIVED

MeSH Terms

Conditions

Radiation Injuries

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Yamei Tang, M.D., Ph.D.

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    STUDY DIRECTOR

Central Study Contacts

Yamei Tang, M.D., Ph.D.

CONTACT

86-13556001992yameitang@hotmail.com

Yi Li, M.D., Ph.D.

CONTACT

86-150187615121024254327@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 8, 2017

First Posted

July 5, 2017

Study Start

July 19, 2017

Primary Completion

January 30, 2020

Study Completion

July 30, 2020

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

CN(3)