Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

February 24, 2017 updated by: Zhejiang Cancer Hospital
Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A prospective phase II trial was conducted to test the efficacy of monosialoganglioside ganglioside for the treatment of cerebral radiation necrosis

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Xiaozhong Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergone only one course of definitive radiotherapy for histologically confirmed nasopharyngeal carcinoma years before;
  • At least two consecutive MRI study supporting the diagnosis of cerebral radiation necrosis(CRN) with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI;
  • Progressive neurologic symptoms or signs;
  • Mini-mental status examination(MMSE) score must be ≤27;
  • Karnofsky performance status≥70 ;
  • Supposed to live more than 6 months.

Exclusion Criteria:

  • After the second course of radiotherapy for recurrent nasopharyngeal carcinoma;
  • Local or regional relapse,or with distant metastasis;
  • Cerebrovascular disease;
  • Second primary malignancy;
  • Diabetes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pulsed steroid
Pulse steroid, methylprednisolone, was administered by intravenous infusion over 3 consecutive days. Three grams of methylprednisolone was given in each cycle. Administration of 1 g was infused over 1 h daily for 3 days on an in-patient basis, which then tailed off in 10 days with administration of oral prednisolone.
Drug: Prednisolone
Drug: Methylprednisolone (Steroid Hormone)
Pulse steroid, methylprednisolone, was administered by intravenous infusion over 3 consecutive days. Three grams of methylprednisolone was given in each cycle. Administration of 1 g was infused over 1 h daily for 3 days on an in-patient basis, which then tailed off in 10 days with administration of oral prednisolone.
EXPERIMENTAL: Monosialoganglioside ganglioside
Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.
Drug: Monosialoganglioside Ganglioside
Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: From the first day of treatment, to 3 months after treatment
Response Evaluation Criteria in Solid Tumors (RECIST) were used.
From the first day of treatment, to 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (ACTUAL)

March 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJCH-2016-HN02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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