EUCTR2011-001977-13-GB进行中（未招募）1 期
A Phase III clinical trial evaluating DCVax®-L, autologous dendritic cells (DC) pulsed with tumor lysate antigen for the treatment of glioblastoma multiforme (GBM) - DCVax®-L for GBM
orthwest Biotherapeutics Inc0 个研究点目标入组 348 人开始时间: 2012年7月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 348
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Determined at pre-screening
- •Patients =18 and =70 years of age at surgery
- •Patients must be able to understand and sign the informed consent. The consent for tumor donation may be signed by a legally authorized representative (LAR) if allowed by the institution.
- •Patients must have a life expectancy of =8 weeks determined at or around surgery, and prior to pre-leukapheresis
- •Primary therapy must consist of surgical resection with the intent for a gross or near gross total resection of the contrast-enhancing tumor mass as confirmed by central review, followed by external beam radiation therapy and concurrent temozolomide chemotherapy.
- •Patients with newly diagnosed, unilateral GBM (Grade IV) without metastases are eligible for this protocol.
- •All Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material.
- •Determined at pre-leukapheresis
- •Patients must have adequate bone marrow function (
- •Adequate liver function
- •Determined at baseline (or baseline2 for pseudoprogression patients)
- •Patients must have a KPS rating of =70 at the Baseline Visit (Visit 5)
- •Patients may have received steroid therapy as part of their primary
- •treatment. Steroid treatment must preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to 2-4 mg dexamethasone qd at least 7 days prior to the first immunization.
- •Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide while being treated with study drug.
- •A minimum of 5 immunizations must be available for treatment as determined by the contracted manufacturer.
- •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 288
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Determined at pre-screening
- •History of prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or other cancers that were deemed fully resolved 5 or more years prior to Visit 1 (surgery) of
- •History of immunodeficiency disease or unresolved autoimmune disease
- •Known HIV-1,2, HTLV-1,2 or Hepatitis B, C infection
- •Pregnancy
- •Inability to obtain informed consent because of psychiatric or complicating medical problems.
- •Any known genetic cancer-susceptibility syndromes.
- •Determined at or around surgery
- •Bilateral or metastatic disease detected at diagnosis, during surgery or at post-surgical magnetic resonance imaging (MRI). Tumors may cross into, but not beyond the corpus callosum.
- •Post operative MRI scan evidence of biopsy only without significant tumor resection.
- •Implantation of Gliadel® wafers (polifeprosan 20 with carmustine implant) at surgery.
- •Positive test(s) for infectious agents (HIV 1 and 2, Anti-HIV-1,2, Hepatitis B, HBsAg, Anti HBc, Hepatitis C, Anti-HCV-Ab, Syphilis) that would preclude eligibility for tumor procurement and processing per manufacturing guidelines.
- •Determined at pre-leukapheresis
- •Positive HIV-1, HIV-2, HTLV-1, 2, hepatitis B surface antigen, or hepatitis C antibody.
- •Patients with organ allografts.
- •Allergies to reagents used in this study.
- •Patients who are unable to stop or taper steroid treatment to less than 8mg of dexamethasone qd prior to leukapheresis
- •Inability or unwillingness to return for required visits and follow-up exams.
- •Any previous cytotoxic drug therapies for the current disease. *note, cytotoxic therapy received for previous malignancies (resolved greater than 5 years prior) is not excluded
- •Determined at or prior to baseline
- •Patients who have evidence of disease progression (including possible pseudoprogression) as determined by central review are not eligible for the study
- •Patients taking medications that might affect immune function and that have documented anti-tumor activity.
- •Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy. Antibiotic therapy must be completed at least 7 days prior to the first immunization.
- •Active uncontrolled infection e.g. a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.
- •Fever =101.5oF. If considered possibly transient, retesting is allowed.
- •Unstable or severe intercurrent medical conditions e.g., unstable angina, uncontrolled arrhythmias, Crohn's Disease, ulcerative colitis etc.
- •Females of child-bearing potential who are pregnant or lactating or
- •who are not using adequate contraception.
研究者
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