Phase 2a Study of an Immunotherapeutic Vaccine, DPX-Survivac, Alone or with Low dose Cyclophosphamide in Primary Glioblastoma Patients Receiving Standard of Care Therapy

Sapienza, University of Rome0 个研究点目标入组 10 人开始时间: 2014年1月7日最近更新: 2018年3月26日

适应症

试验速览

暂无简介。

•1.Primary or recurrent histologically confirmed GBM after surgery
•2.Total or subtotal (at least 90%) resection of tumour mass, confirmed by assessment of neurosurgeon and postoperative magnetic resonance imaging (MRI) within 48 hours
•3.Ages 18 to 70 years old
•4.Postoperative Karnofsky Performance Status (KPS) =70
•5.A life expectancy > 6 months
•6.Adequate hematologic, renal and hepatic function
•7.Fertile subjects must use acceptable birth control from screening until the last study visit or early termination. Acceptable methods of birth control include: spermicide with condom, diaphragm, or cervical cap, IUD (intrauterine device), hormonal contraception, vasectomy, and abstinence. (Plan B or the rhythm method are not considered reliable methods.)
•8.Willing and able to provide written informed
•9.Ability to comply with protocol requirements
•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 7
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•1.Past or ongoing documented autoimmune diseases
•2.HIV, syphilis, active HBV and HCV infection
•3.Any medical disorder that would impair the ability to receive study treatment
•4.Other active of in the past five years malignancies
•5.Any unresolved chronic toxicity greater than Grade 2 (NCI-CTCAE version 4.03) from previous anticancer therapy (except alopecia)
•6.Pregnant or breast feeding patients
•7.Documented immune deficiency
•8.Lymphodemia in the region to be vaccinated
•9. Mandatory treatment with corticosteroids or salicylates in inflammatory dose

发起方