Status:
UNKNOWN
Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Hangzhou Normal University
Conditions:
Refractory Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a pilot phase I study to evaluate the safety and efficacy on elemene injectable emulsion in treating patients with glioblastoma. Elemene, isolated from the Chinese medicinal herb Curcuma wenyu...
Detailed Description
Background * 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 th...
Eligibility Criteria
Inclusion
- Age ≥ 18 years; Male or Female.
- Relapsed/refractory disease confirmed by radiographic evidence after standard therapy.
- KPS ≥ 60
- ≥ 8 weeks after completion of front-line radiation therapy
- ≥ 6 weeks after completion of nitrourea chemotherapy
- ≥ 14 days after completion of Temozolomide or other chemotherapy
- 2 weeks of wash-out time after completion of targeted therapy with related adverse events (AE) on baseline
- White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
- Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
- Patients must be able to understand the investigational nature of the study and provide informed consent.
Exclusion
- Those who are allergic constitution, or have contraindications to CT and MRI1 contrast agents.
- Those who plan to receive any other anti-tumor treatment during the trial.
- 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.
- Patients with other malignant tumors.
- Those with active infections, etc.
- Suspected or confirmed a history of alcohol and drug abuse.
- Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
- Women who are pregnant or nursing.
- Women of childbearing age who refuse to contraception.
- Active participation in another clinical treatment trials.
- According to the judgment of the investigator, other conditions that the plan cannot be followed.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04674527
Start Date
June 1 2021
End Date
June 1 2023
Last Update
December 19 2020
Active Locations (1)
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1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009