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

Study Purpose

This study is being conducted to help determine whether β-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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - - Page 3 of 4 [DRAFT] - Arms Assigned Interventions.
  • - Temodar Experimental: temozolomide +α-IFN Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN： 3mIU (3million) Day1,3,5 of each 28 day TMZ：150 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: α-IFN 3mIU (3million) D1，3，5. 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02629757
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sun Yat-sen University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Zhong-ping CHEN
Principal Investigator Affiliation Sun Yat-sen University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Anaplastic Oligoastrocytoma, Anaplastic Astrocytoma, Glioblastoma
Additional Details

This study is being conducted to help determine whether β-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. β-elemene will be given 600mg/d,d1-14,q28 days for 6 cycles.

Arms & Interventions

Arms

Experimental: β-elemene

β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles.

Interventions

Drug: - β-elemene

β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong,

Site Contact

Zhong-ping Chen

chenzhp@sysucc.org.cn

+86-20-87343310

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