Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma
NCT ID: NCT04674527
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2021-06-01
2023-06-01
Brief Summary
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Detailed Description
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* Elemene, isolated from the Chinese medicinal herb Curcuma wenyujin, was shown to exhibit antitumor activity in human and murine tumor cells in vitro and in vivo
* The study shows that the methodological quality of RCTs of Elemene injectable emulsion against malignant tumors was low. Therefore, the effect of Elemene injectable emulsion being used in clinical settings needs to be confirmed by further RCTs
Objectives
* To evaluate the safety of Elemene injectable emulsion to treat Refractory Glioblastoma with TMZ
* To evaluate the efficacy of Elemene injectable emulsion to treat Refractory Glioblastoma with TMZ
Design
This clinical trail is a randomized controlled trial.In control group,patients will receive TMZ-chemotherapy.In experimental group,patients will receive elemene injectable emulsion and TMZ-chemotherapy at the same time.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental group
Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.And elemene injectable emulsion will be given for 80 -120 ml/day in each 14-day cycle or 21-day cycle.
Elemene
Elemene injectable emulsion will be given for 80 mg/day in each 14-day cycle.
Temozolomide
Maintenance chemotherapy with TMZ will be administered at 150 mg/m2/day for 5 days in each 28-day cycle.
contral group
Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.
Temozolomide
Maintenance chemotherapy with TMZ will be administered at 150 mg/m2/day for 5 days in each 28-day cycle.
Interventions
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Elemene
Elemene injectable emulsion will be given for 80 mg/day in each 14-day cycle.
Temozolomide
Maintenance chemotherapy with TMZ will be administered at 150 mg/m2/day for 5 days in each 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Relapsed/refractory disease confirmed by radiographic evidence after standard therapy.
3. KPS ≥ 60
4. ≥ 8 weeks after completion of front-line radiation therapy
5. ≥ 6 weeks after completion of nitrourea chemotherapy
6. ≥ 14 days after completion of Temozolomide or other chemotherapy
7. 2 weeks of wash-out time after completion of targeted therapy with related adverse events (AE) on baseline
8. White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
9. Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
10. Patients must be able to understand the investigational nature of the study and provide informed consent.
Exclusion Criteria
2. Those who plan to receive any other anti-tumor treatment during the trial.
3. Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
4. Patients with other malignant tumors.
5. Those with active infections, etc.
6. Suspected or confirmed a history of alcohol and drug abuse.
7. Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
8. Women who are pregnant or nursing.
9. Women of childbearing age who refuse to contraception.
10. Active participation in another clinical treatment trials.
11. According to the judgment of the investigator, other conditions that the plan cannot be followed.
18 Years
ALL
No
Sponsors
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Hangzhou Normal University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Jianmin Zhang, MD
Role: STUDY_CHAIR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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SAHZJU-RCT-ELEMENE
Identifier Type: -
Identifier Source: org_study_id