Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma (BRAIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01621880
First received: June 14, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Bevacizumab may have a better effect on brain necrosis caused by radiotherapy.This randomized trial aims to investigate whether bevacizumab may alleviate radiation-induced brain necrosis in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in patients receiving steroid therapy.


Condition Intervention Phase
Nasopharyngeal Carcinoma
Adverse Effect of Radiation Therapy
Brain Necrosis
Drug: bevacizumab
Drug: Methylprednisolone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:

Primary Outcome Measures:
  • Change in magnetic resonance imaging (MRI) of radiation-induced brain necrosis in patients [ Time Frame: Change form baseline to evaluation at 8 weeks. ] [ Designated as safety issue: No ]
    1. To determine whether bevacizumab can reduce radiation-induced brain necrosis in patients with nasopharyngeal carcinoma.
    2. To compare the different treating effect between bevacizumab and steroid.


Secondary Outcome Measures:
  • Change of neurologic function and quality of life of patients after treatment [ Time Frame: Change from baseline to evaluation at 8 weeks. ] [ Designated as safety issue: No ]
    1. To determine what extent bevacizumab can improve neurologic function in these patients.
    2. To determine what extent this drug can improve quality of life in these patients


Enrollment: 43
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bevacizumab
Patients receive bevacizumab IV over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: bevacizumab
Patients receive bevacizumab IV over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Other Name: Bevacizumab(Avastin)
Active Comparator: Methylprednisolone
Patients receive intravenous steroid over 5 consecutive days. The dosage was decreased gradually. The regimen repeats every other month for up to 4 courses.
Drug: Methylprednisolone
Patients receive intravenous steroid over 5 consecutive days. The dosage was decreased gradually. The regimen repeats every other month for up to 4 courses.
Other Name: Methylprednisolone(Solu-Medrol)

Detailed Description:

Radiation-induced brain necrosis is a severe complication of radiotherapy in patients with Nasopharyngeal carcinoma. Current neuroprotective therapies show limited benefit in ameliorating this complication of radiotherapy. This study is a randomized, single blind clinical study. The primary aim of this study is to determine whether bevacizumab can alleviate radiation-induced brain necrosis in patients with nasopharyngeal carcinoma, and to compare the treating effect between bevacizumab and steroid.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have received radiotherapy for histologically confirmed nasopharyngeal carcinoma.
  • Prior irradiation >/= 6 months prior to study entry.
  • Radiographic evidence to support the diagnosis of radiation-induced brain necrosis without tumor recurrence.
  • Age>/= 18 years. Because on dosing or adverse event data are currently not available on the use of bevacizumab in patients <18years old.
  • No prior bevacizumab therapy.
  • No evidence of very high intracranial pressure that suggests brain hernia and needs surgery.
  • Fertile women who are willing to take contraception during the trial.
  • Routine laboratory studies with bilirubin </=2 * upper limits of normal (ULN), 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.
  • If with history of seizures, patients should be on anticonvulsant therapy. However, preference will be enzyme-non-inducing anticonvulsants.
  • Ability to understand and willingness to sign a written informed consent document.
  • 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:

  • Patients with any of the following should be excluded: 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.
  • Evidence of active central nervous system hemorrhage.
  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to study enrollment.
  • inadequately controlled hypertension (systolic blood pressure (SBP) > 140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg despite antihypertensive medication)
  • 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.
  • Evidence of bleeding diathesis or coagulopathy.
  • Patients who have received steroid therapy for radiation-induced brain necrosis before the study.
  • History of anaphylactic response to bevacizumab.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621880

Locations
China, Guangdong
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
Principal Investigator: Yamei Tang, Ph.D Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Yamei Tang, Associate Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01621880     History of Changes
Other Study ID Numbers: 2012025, SYSN001
Study First Received: June 14, 2012
Last Updated: December 9, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
radiation-induced brain necrosis
nasopharyngeal carcinoma
Bevacizumab
Methylprednisolone

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Necrosis
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pathologic Processes
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Bevacizumab
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents

ClinicalTrials.gov processed this record on November 20, 2014