The Therapeutic Effect of Thalidomide in RI

• Status: Unknown status
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Treatments: Thalidomide

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: bilirubinaminotransferase (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.