A Study on -elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas

  • STATUS
    Recruiting
  • End date
    May 22, 2023
  • participants needed
    100
  • sponsor
    Sun Yat-sen University
Updated on 22 January 2021

Summary

This study is being conducted to help determine whether -elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma.

Description

This study is being conducted to help determine whether -elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma. -elemene will be given 600mg/d,d1-14,q28 days for 6 cycles.

Details
Condition Astrocytoma, Glioma, Gliomas, Glioblastoma Multiforme, Glioblastoma Multiforme, Anaplastic Oligoastrocytoma, Gliomas, anaplastic astrocytoma, glioblastoma, astrocytoma, anaplastic
Treatment β-elemene
Clinical Study IdentifierNCT02629757
SponsorSun Yat-sen University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\- Page 3 of 4 [DRAFT] - Arms Assigned Interventions
Temodar Experimental: temozolomide +-IFN Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus -IFN -IFN 3mIU (3million) Day1,3,5 of each 28 day TMZ150 mg/m^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles Drug: Temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
Other Names
Temodar Drug: -IFN 3mIU (3million) D135
Other Names
Minimum Age: 18 Years Maximum Age: 75 Years Gender: Both Accepts Healthy
Volunteers?: No
Criteria: Inclusion Criteria
Age: 18 years to 75 years
complete remission patients of newly diagnosed WHO III-IV glioma following standard treatment
Karnofsky Performance Score 60
Adequate bone marrow, liver and renal function
Ability of subject to understand character and individual consequences of the clinical trial
Written informed consent
anticipating survival 2 months

Exclusion Criteria

Refusal to participate the study
Known hypersensitivity or contraindication to temozolomide
Incompletely radiation
Pregnant or lactating females
Malignant tumor other than brain tumor
Contraindicated for MRI examination
Unable to comply with the follow-up studies of this trial
Purulent and chronic infected wounds
Uncontrolled psychotic disorders or epilepsy
progression disease
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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