REPURPOSING THE ANTIPSYCHOTIC DRUG CLORPROMAZINE AS A THERAPEUTIC AGENT IN THE COMBINED TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME - RACTAC

ISTITUTI FISIOTERAPICI OSPITALIERI0 个研究点目标入组 41 人开始时间: 2021年5月24日最近更新: 2021年8月24日

适应症

试验速览

暂无简介。

•1- Newly diagnosed histologically-confirmed supra-tentorial GBM (World Health Organization grade IV) patients. Whenever feasible, patients will undergo maximal surgical resection or debulking, although patients with inoperable glioblastomas are also eligible.
•2- Patients undergone complete standard concomitant chemoradiotherapy with TMZ.
•3-Patients with provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
•4- Additional eligibility criteria include: age between 18 and 70; Karnofsky Performance Status (KPS) score of 70 or higher; adequate kidney, liver, bone marrow, and cardiac function; total serum bilirubin level and liver- function values; IDH1/2 mutational status; MGMT methylation status assessment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 21

•1. Treatment with any of the following:
•Any other chemotherapy, immunotherapy or anticancer agents within 4 weeks before enrollment in the study.
•Any investigational agents or study drugs from a previous clinical study within 30 days before the first dose of study treatment.
•methylatedMGMT status.
•2. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including: uncontrolled hypertension; active bleeding diatheses; active HBV, HCV or HIV infection. Screening for chronic conditions is not required; inadequate bone marrow reserve or organ function, as demonstrated by laboratory parameters.
•3. Judgment by the investigator that the patient should not participate at the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
•4. Contraindications to MRI and or MRS.
•5. Patients not able to sign the informed consent.

发起方

ISTITUTI FISIOTERAPICI OSPITALIERI