EUCTR2014-000676-26-PL进行中（未招募）不适用
A Phase 2 Trial of Cvac (Autologous Dendritic Cells Pulsed with Recombinant Human Fusion Protein [Mucin 1-Glutathione S-Transferase] Coupled to Oxidized Polymannose) in Patients with Resected Stage I or Stage IIAdenocarcinoma (Cancer) of the Pancreas
Prima BioMed Ltd0 个研究点目标入组 40 人开始时间: 2014年9月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •Patients may be enrolled if they meet all of the following criteria at screening:
- •1. Histologically or cytologically diagnosed adenocarcinoma of the pancreas, stage I or stage II disease;
- •2. Postoperative confirmed R0 or R1 resection status with no evidence of residual disease based on radiographic imaging;
- •3. CA 19-9 less than 2 × the ULN by the central laboratory;
- •4. No greater than 6 weeks since completion of prior therapy, which includes surgery with or without radiation or chemotherapy;
- •5. Mucin 1-positive tumor as determined by central immunohistopathology. Sites will be asked to submit archival tissue (patients may start the study if tissue is available at an outside hospital, but not yet requested or received);
- •6. Signed an ICF;
- •7. Willing and able to complete study procedures within the study timelines;
- •8. Life expectancy of at least 6 months in the investigator’s opinion;
- •9. = 18 years of age;
- •10. ECOG performance status < 2 (Karnofsky = 70%);
- •11. Normal organ and marrow function: serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 × ULN and serum bilirubin = 1.5 × ULN unless Gilbert’s syndrome has previously been confirmed for the patient, white blood cells (WBCs) = 3.0 K/µL, absolute neutrophil count (ANC) = 1.0 × 109/L, hemoglobin = 8 g/dL, and platelets = 100 × 109/L;
- •12. Not pregnant, and if of childbearing potential, agrees to use a highly effective method of birth control (implanted, injectable, or oral combination hormonal method alone or in possible combinations, intrauterine device, vasectomized partner, or abstinence) prior to study entry, for the duration of the study, and for 3 months after the last dose of Cvac. Male partners of a study patient must use a condom in addition to the acceptable method of contraception for the female partner as specified above.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Active, acute, or chronic clinically significant infections or bleeding;
- •2. Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) or history of congestive heart failure (= Grade 2);
- •3. Active angina pectoris, stroke, or recent myocardial infarction (within 6 months);
- •4. Additional uncontrolled, serious medical or psychiatric illness;
- •5. Evidence or history of central nervous system metastases;
- •6. Inadequate renal function defined as a creatinine clearance < 60 mL/min as determined by the central laboratory;
- •7. Additional malignancy diagnosed within 5 years of study enrolment, except carcinoma in situ of the cervix or basal cell and squamous cell carcinomas of the skin;
- •8. Treatment with any other investigational agent (for any condition) within 4 weeks of screening;
- •9. Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum [TPHA]);
- •10. Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose;
- •11. Active autoimmune disease; any previous autoimmune disease must not require chronic treatment in the 6 months prior to screening.
研究者
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