A phase I- IIa open-label clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced solid tumors

VU University Medical Center0 个研究点目标入组 27 人开始时间: 2013年7月18日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•-Histologically confirmed advanced, solid malignancy.
•-Refractory or not amenable to standard therapy
•-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•-Willing and able to give written informed consent
•-Patient is = 18 years of age at the time of signature of the informed consent
•-Adequate hematological function: Absolute neutrophil count (ANC) = 1.5 x 109/L, platelets = 100 x 109/L, Hemoglobin = 6.0 mmol/L.
•-Adequate hepatic function: serum bilirubin = 1.5 times the upper limit of normal (ULN), ALT and AST = 2.5 x ULN (or = 5 times ULN if liver metastases are present).
•-Adequate renal function: eGFR = 50ml/min
•-Female patients of childbearing potential may be enrolled in the study, if the patient
•oHas practiced adequate contraception for 30 days prior to first hVEGF26-104/RFASE administration.
•oNegative pregnancy test
•oHas agreed to continue adequate contraception for as long as VEGF is neutralized.
•-Part 2 only:
•oHistological confirmed advanced colorectal cancer
•oPlanning to initiate treatment with irinotecan or
•oPlanning to initiate second line treatment with the XELOX regimen after progression on first line treatment with XELOX combined with bevacizumab.
•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 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•-Major surgery within 28 days before the initiation of study treatment
•-Any serious non-healing wounds, ulcers, or bone fractures within 28 days prior to the initiation of study treatment.
•-Deep venous thrombosis (DVT) or pulmonary embolus (PE) within 1 year prior to the initiation of study treatment.
•-Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)
•-The patient is scheduled to receive another vaccination during the DLT period.
•-A previous serious allergic reaction to a vaccine such as angioedema and anaphylaxis.
•-Treatment with bevacizumab within 6 weeks prior to the initiation of study treatment.
•-Primary or secondary immunodeficiency
•-Treatment with a glucocorticoid derivative in an equivalent dose of = 10mg prednisone a day.
•-Female patients: the patient is pregnant or lactating.
•-Part 1 only:
•oWhen the patient is scheduled to receive any other anticancer treatments than those specified in the protocol.
•oChemotherapy within 28 days prior to the initiation of study treatment.

发起方

VU University Medical Center