Overview

Treatment of Bevacizumab Followed by Steroid in RN

Status:
Recruiting
Trial end date:
2021-06-30
Target enrollment:
0
Participant gender:
All
Summary
Treatment of bevacizumab followed by steroid may have a better effect on patients with radiation-induced brain injury.This randomized trial aims to investigate whether treatment of bevacizumab followed by steroid may alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in patients receiving steroid therapy
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Treatments:
Bevacizumab
Criteria
Inclusion Criteria:

1. Patients must have received radiotherapy for histologically confirmed nasopharyngeal
carcinoma.

2. Prior irradiation >/= 6 months prior to study entry.

3. Radiographic evidence to support the diagnosis of radiation-induced brain necrosis
without tumor recurrence.

4. Age>/= 18 years. Because on dosing or adverse event data are currently not available
on the use of bevacizumab in patients <18years old.

5. No prior bevacizumab therapy.

6. No evidence of very high intracranial pressure that suggests brain hernia and needs
surgery.

7. Fertile women who are willing to take contraception during the trial.

8. Routine laboratory studies with bilirubin aspartate aminotransferase (AST or SGOT) < 2 * ULN, creatinine <1.5 * ULN, red-cell
count >/= 4,000 per cubic millimeter; white-cell count >/=1500 per cubic millimeter,
platelets >/= 75,000 per cubic millimeter; Hb >/=9.0. PT, APTT, INR in a normal range.

9. If with history of seizures, patients should be on anticonvulsant therapy. However,
preference will be enzyme-non-inducing anticonvulsants.

10. Ability to understand and willingness to sign a written informed consent document.

11. The patient has no active bleeding or pathological condition that carries a high risk
of bleeding; there is no evidence of serious or non-healing wound, ulcer or bone
fracture.

Exclusion Criteria:

1. evidence of metastatic disease;

2. evidence of tumor invasion to major vessels(e.g. the carotid);

3. history of bleeding related to tumor or radiotherapy during or after the completion of
radiation.

4. Evidence of active central nervous system hemorrhage.

5. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 28 days prior to study enrollment.

6. inadequately controlled hypertension (systolic blood pressure (SBP) > 140 mmHg and/or
diastolic blood pressure (DBP) > 90 mmHg despite antihypertensive medication)

7. Severe complications: 1) History of large vessel cerebrovascular accident (CVA) within
6 months; 2) Myocardial infarction or unstable angina within 6 months; 3) New York
heart association grade II or greater congestive heart failure; 4) Serious and
inadequately controlled cardiac arrhythmia; 5) Significant vascular disease (e.g.
aortic aneurysm, history of aortic dissection); 6) Clinically significant peripheral
vascular disease; 7) severe infection.

8. Evidence of bleeding diathesis or coagulopathy.

9. Patients who have received steroid therapy for radiation-induced brain necrosis before
the study.

10. History of anaphylactic response to bevacizumab.