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Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03067753
Recruitment Status : Unknown
Verified January 2017 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Brief Summary:
Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Condition or disease Intervention/treatment Phase
Cerebral Radiation Necrosis Drug: Monosialoganglioside Ganglioside Drug: Methylprednisolone (Steroid Hormone) Drug: Prednisolone Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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: 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.

Drug: 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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067753


Locations
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China, Zhejiang
Xiaozhong Chen Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiaozhong Chen, MD    +86-571-88128202    cxzfyun@sina.com   
Sponsors and Collaborators
Zhejiang Cancer Hospital
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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03067753    
Other Study ID Numbers: ZJCH-2016-HN02
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Necrosis
Pathologic Processes
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Hormones
Prednisolone hemisuccinate
Prednisolone phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents