NCT00706615撤回1 期
A Single Arm Open-Label Phase I Study of An Injectable Replication-Incompetent Adenoviral Vector Vaccine Used to Produce An Immune Response to MUC-1 Positive Epithelial Cancer Cells in Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Identification of a tolerable, immunologically active dose level
研究概览
简要总结
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating women with previously treated metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Characterize the safety profile of Ad-sig-hMUC-1/ecdCD40L vaccine in women with metastatic breast cancer.
- Identify a tolerable, immunologically active dose level of this vaccine in these patients.
Secondary
- Evaluate the immune function in these patients before and after treatment with this vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over the age of 18 with metastatic or non-measureable adenocarcinoma of the breast with marrow involvement.
- •Elevated serum MUC-1 levels, as measured by CA 15-3 or CA 27-29
- •Stable disease (defined as fluctuation of <50U in CA15-3 or CA27-29 value) for at least 3 months while either on no breast-cancer therapy or while on current therapy (Tamoxifen, fulvestrant, exemestane, letrozole, anastrozole, bisphosphonates or trastuzumab chemotherapy is not allowed)
- •ability to understand the risks, benefits, and procedures and provide written informed consent.
- •less than 28 days prior to enrollment since last surgery and/or radiation therapy.
- •performance status <=2 on the ECOG performance scale and life expectancy of greater than 12 months
- •NYHA cardiac function Class I or Class II and normal baseline ECG. If ECG is abnormal, patient must have an echocardiogram showing a left ventricular ejection fraction greater than the lower limits of normal.
- •patients who do not have radiographically assessable locally recurrent or metastatic disease are eligible if they 1) had radiographic or biopsy proven locally recurrent or metastatic breast cancer in the past and 2) currently (at study entry) have an elevated serum MUC-1 level (as measured by CA 15-3 or CA 27-29).
- •Acceptable pulmonary function. if questionable, a pulmonary function test will be performed.
- •negative serology for hepatitis B, C and HIV.
- •red cell mean corpuscular volume >- 80 cu. mm, hemoglobin >- 8g/dl, platelet count >- 100,000/dl: AST, ALT, LDH <-2 times the Upper limit of normal
- •Serum creatinine < 1.6 mg/dL
- •for women with child bearing potential, Negative urine pregnancy test within 7 days of registration and willingness to use an approved contraceptive method while participating in this trial.
排除标准
- •history of bronchospasm or asthma requiring inhaled or oral steroid treatment
- •Normal MUC-1 (CA 15-3 or CA 27-29)
- •treatment with steroid or other immunosuppressive medication (for any condition ) within 30 days of trial registration.
- •history of any autoimmune disease (e.g., lupus, rheumatoid arthritis, or psoriasis)
- •uncontrolled diabetes mellitus
- •unable or unwilling to undergo repeated clinical evaluations and other diagnostic procedures or unable to sign an informed consent.
- •history of other malignancies, except squamous cell or basal cell carcinoma of the skin or cervical carcinoma in situ.
- •Concurrent systemic chemotherapy (tamoxifen, aromatase inhibitors, fulvestrant, trastuzumab and biophosphonates are allowed if started more than 3 months prior to trial registration with evidence of stable disease as defined above. Chemotherapy must have stopped 3 months prior to enrolling in this trial).
- •history of ornithine transcarbamylase deficiency
- •any acute or chronic viral, bacterial, or fungal infection requiring specific therapy, unless acute therapy was completed within the past 14 days
- •No underlying conditions that would contraindicate therapy with study treatment ( or allergies to reagents used in this study)
- •history of organ transplant or allogeneic bone marrow transplant
- •life threatening or organ-threatening disease expected to require conventional therapy within 4 months.
- •pregnant or nursing females.
结局指标
主要结局
Identification of a tolerable, immunologically active dose level
Characterize the safety profile of the Ad-sig-hMUC-1/ecdCD40L vector vaccine
次要结局
- Assess efficacy based on serum MUC-1 level
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV MelanomaMelanoma (Skin)NCT00010309Genzyme, a Sanofi Company
已完成
1 期
Vaccine Therapy in Treating Patients With Stage IV MelanomaMelanoma (Skin)NCT00023647Mannkind Corporation26
Unknown
2 期
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With SurgeryMelanoma (Skin)NCT00086866European Organisation for Research and Treatment of Cancer - EORTC165
已完成
1 期
Vaccine Therapy in Treating Patients With Stage IV MelanomaMelanoma (Skin)NCT00033228Mannkind Corporation19
终止
1 期
Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue SarcomaSarcomaNCT00027911Columbia University