Phase I Study of an Active Immunotherapy for Asymptomatic Phase Lymphoplasmacytic Lymphoma With DNA Vaccines Encoding Antigen-Chemokine Fusion
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity according to the National Cancer Institute Common Toxicity Criteria version 4.0
研究概览
简要总结
This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with lymphoplasmacytic lymphoma. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the safety and feasibility of using a novel lymphoma deoxyribonucleic acid (DNA) vaccine encoding macrophage inflammatory protein 3 alpha (MIP3a)-fused lymphoma idiotype in single chain format.
II. To determine the maximum tolerated dose (MTD) of the vaccine.
SECONDARY OBJECTIVES:
I. To assess the immunogenicity of the vaccine to generate tumor-specific cellular and humoral immune responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tissue diagnosis of lymphoplasmacytic lymphoma with surface immunoglobulin G (IgG), immunoglobulin A (IgA) or immunoglobulin M (IgM) phenotype with a monoclonal heavy and light chain as determined by flow cytometry; all primary diagnostic lymph node and/or bone marrow biopsies will be reviewed at the University of Texas M.D. Anderson Cancer Center (UTMDACC)
- •Previously untreated patients with lymphoplasmacytic lymphoma (of any subtype: IgG, IgA, IgM) in the asymptomatic phase
- •Patients must provide a lymph node sample of at least 1.5 cm in the long axis, or a bone marrow aspiration sample providing at least 5 million cluster of differentiation (CD)20 and/or CD38+ (approximately 10 ml)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Serum creatinine =< 1.5 mg/dl and a creatinine clearance >= 30 ml/min
- •Total bilirubin =< 1.5 mg/dl unless felt secondary to Gilbert's disease
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 x upper limit of normal
- •Ability to provide informed consent, and to return to clinic for adequate follow-up for the period that the protocol requires
- •Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 30 days after the last vaccination has been administered
- •Male subject agrees to use an acceptable method for contraception for the duration of the study
排除标准
- •Human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C infection
- •Pregnancy or lactating females
- •Patients with previous history of malignancy within the last 5 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in-situ of other organs
- •Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
- •Patients with New York Heart Association class 3 or 4 disease
- •Patients with a history of autoimmune diseases except for Hashimoto's thyroiditis
- •Patients with positive antinuclear antibody (ANA) and/or anti-double strand (ds) DNA antibodies
研究组 & 干预措施
Treatment (vaccine therapy)
Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.
干预措施: Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine (Biological)
Treatment (vaccine therapy)
Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Maximum tolerated dose defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity according to the National Cancer Institute Common Toxicity Criteria version 4.0
时间窗: 4 weeks
Toxicity type and severity will be summarized by frequency tables.
次要结局
- Immune response defined as at least a three-fold rise in the precursor frequency of tumor-reactive T cells(At 12 weeks)