EUCTR2011-001977-13-DE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 trial for GBM
orthwest Biotherapeutics, Inc0 个研究点目标入组 348 人开始时间: 2013年2月11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 time of surgery
- •Patients must be able to understand and sign the informed consent indicating that they are aware of the investigational nature of this study. 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 visit
- •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 who have a resection with original intent for gross or near gross total resection where the surgery can be said to be beyond biopsy are eligible. Central confirmation is not required prior to the pre-leukapheresis visit, but is required before the patient can proceed to leukapheresis. Patients having a biopsy only will be excluded. Patients may be screened if they have had a previous biopsy and are scheduled for a subsequent gross or near gross total resection prior to commencement of other therapies.
- •Patients with newly diagnosed, unilateral GBM (Grade IV) without metastases are eligible for this protocol. An independent central neuropathologist will review this diagnosis during the enrollment process. This confirmation is not required prior to the pre-leukapheresis visit, but is required before the patient can proceed to leukapheresis.
- •All Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. This determination will be made by the contracted manufacturer and communicated to the clinical site through the Sponsor, or its designee. This confirmation is not required prior to the pre-leukapheresis visit, but is required before the patient can proceed to leukapheresis.
- •Determined at pre-leukapheresis visit
- •Patients must have adequate bone marrow function prior to each leukapheresis procedure (hemoglobin >10 g/dl or >100g/L, white blood count = 3.6x10E3/mm3 or = 3.6x10E9/L, absolute granulocyte count =1.5x10E3/mm3 or =1.5x10E9/L, absolute lymphocyte count =0.5x10E3/mm3 or =0.5x10E9/L, and platelet count =100x10E3/mm3 or =100x10E9/L). Patients for whom a transfusion is clinically indicated may be considered eligible based on post-transfusion Hgb levels. These values are determined by a central laboratory.
- •Adequate liver function (SGPT, SGOT, and alkaline phosphatase =4.0 times upper limits of normal (ULN) and total bilirubin =1.5 mg/dl or <25.7 µmol/L), and adequate renal function (BUN or creatinine =1.5 times ULN) prior to starting therapy. These values are determined by a central laboratory.
- •Determined at baseline visit
- •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 should preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to no more than 4 mg dexamethasone per day (or equivalent) 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/placebo. DCVax-L and placebo must be given as described and temozolomide must be given essentially according to the Stupp P
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 the study. Prior lower grade gliomas are acceptable unless treated with chemotherapy, and provided that all other eligibility criteria are met.
- •History of immunodeficiency disease or unresolved autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or vasculitis.
- •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.
- •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 applicable manufacturing guidelines (e.g. German manufacturing vendors).
- •Post operative MRI scan evidence of biopsy only without significant tumor resection.
- •Implantation of Gliadel® wafers (polifeprosan 20 with carmustine implant) at surgery.
- •Determined at pre-leukapheresis visit
- •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 no more than 4mg of dexamethasone per day (or equivalent) prior to leukapheresis are excluded from the trial; steroid use should be stopped or tapered down to the lowest clinically acceptable dose approximately 7 days prior to leukapheresis. The Leukapheresis Visit must occur a minimum of 45 days before the projected Baseline Visit.
- •Inability or unwillingness to return for required visits and follow-up exams.
- •Any previous cytotoxic drug therapies within the last 5 years.
- •Determined at or prior to baseline visit
- •Patients who have evidence of disease progression (including possible pseudoprogression) as determined by central review
- •Patients may not be taking medications that might affect immune function and that have documented anti-tumor activity: The following are exceptions: nonprescription strength doses of NSAIDS, acetaminophen (paracetamol) or acetylsalicylic acid (aspirin).
- •Determined at baseline visit:
- •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. Examples are a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.
- •Fever =101.5°F (38.6 °C). If considered possibly transient, retesting is allowed.
- •Unstable or severe intercurrent medical conditions such as unstable angina, uncontrolled arrhythmias, ulcerative colitis etc.
- •Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (abstinence, surgical, hormonal or double barrier, i.e. condom and diaphragm).
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