NCT00561756已完成1 期
Phase I Trial to Assess Safety and Immunogenicity of Xenogeneic CD20 DNA Vaccination With Patients With B-Cell Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Safety and immunogenicity
研究概览
简要总结
RATIONALE: Vaccines made from mouse DNA may help the body build an effective immune response to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of mouse DNA vaccine in treating patients with recurrent B-cell lymphoma.
详细描述
OBJECTIVES:
Primary
- To evaluate the safety and feasibility of intramuscular DNA vaccination with a plasmid DNA vector expressing the mouse extracellular domain of CD20, namely pINGmminiCD20. Doses of pING-mminiCD20 will be escalated by group to determine the optimal biological dose.
Secondary
- To evaluate antibody and T-cell responses to CD20 after vaccination.
- To observe patients for evidence of any antitumor response generated after vaccination.
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
- •Patients must have a functional immune system as determined by the following tests:
- •Serum proteins immunoelectrophoresis (serum IgG levels ≥ 0.5 g/dL are required)
- •No evidence of anergy as shown by positive skin test with tetanus toxoid, mumps or Candida. OR
- •Circulating T-cells as measured by flow cytometry (serum CD4+ and CD8+ T-cell counts ≥ 250 and 150 cells/μL, respectively) Patients must have histologically proven (and confirmed at MSKCC) B-cell lymphoma of any histology, excluding Burkitt's lymphoma, Lymphoblastic lymphoma (due to their aggressiveness and low likelihood of response to immune therapy).
- •CD20 surface expression must be confirmed by immunohistochemical staining or flow.
- •Measurable disease is not a pre-requisite for enrollment in the study. However, if a patient does have measurable disease as evidenced by imaging studies, these have to be done within eight weeks of starting treatment.
- •Patients must have a Karnofsky performance status ≥ 70%.
- •Patients with evidence of active disease, progression of disease or relapsed disease following one or more prior regimens of chemotherapy, immunotherapy or radiation therapy (including autologous stem cell transplants), not requiring immediate cytoreductive chemotherapy. All treatment must be completed at least four weeks prior to administration of the first vaccination, except immunotherapy and radioimmunotherapy, which must be completed at least 90 days prior to receiving the first vaccination. Active disease includes patients with minor or partial responses after therapy as evidenced by FDG-avid disease or biopsy.
- •Adequate contraception during study enrollment.
- •Avoidance of breast-feeding their infants during the study enrollment.
- •Patients must have adequate organ and marrow function as defined below:
- •Absolute Neutrophil Count ≥ 1,000/uL
- •Platelets ≥ 75,000/uL
- •Total bilirubin ≤ 2.5 times institutional upper limit
- •AST/ALT ≤ 2.5 times institutional upper limit
- •Creatinine ≤ 2 mg/dL
- •PT/PTT ≤ 1.5 times institutional upper limit
- •Patients must have no signs of congestive heart failure according to the New York Heart Failure Guidelines Class III/IV.
排除标准
- •Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study.
- •Patients who have undergone an allogeneic stem cell transplant at any time.
- •Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- •Patients who have received immunotherapy (i.e. rituximab) or radioimmuno therapy (i.e. tositumomab or ibritumomab) within the past 90 days.
- •Patients who display signs of anergy as indicated by skin testing.
- •Patients with Burkitt's lymphoma and Lymphoblastic Lymphoma.
- •Patients who have been previously immunized with any type of DNA vaccine.
- •Patients who have positive anti-DS-DNA antibodies.
- •Patients with life expectancy less than 3 months from the time of enrollment.
- •Patients with serious underlying medical conditions, active infections requiring the use of antimicrobial drugs or active bleeding.
- •Patients with active Hepatitis C (HC) or Hepatitis B (HB) infection, the latter defined as a positive test for HBsAg or measurable viral load. In patients who are HBsAg negative but HBsAg positive (regardless of HBsAb status), a HB viral load will be performed and if positive the subject will be excluded. If the subject is HBsAg negative, HBcAb positive (regardless of HBsAb status) but with negative HBV viral load, the subject may be included but must undergo HBV DNA PCR testing at least every two months from the start of treatment during the routine study visits for as long as the subject remains on study. Prophylactic antiviral therapy, in addition to the monitoring described above, may be initiated at the discretion of the investigator.
- •Patients with documented HIV infection or other immunodeficiency disorder or on chronic steroids treatment.
- •Patients with autoimmune diseases such as but not limited to rheumatoid arthritis, Sjogren disease, ulcerative colitis, autoimmune hepatitis.
- •Pregnant or nursing women. Women of child-bearing age will be tested for qualitative β-HCG within 2 weeks of immunization.
- •Patients receiving other investigational drug.
结局指标
主要结局
Safety and immunogenicity
时间窗: 2 years
次要结局
- Antibody and T-cell responses against CD20(2 years)
- Antitumor response(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian CancerHER2-positive Breast CancerStage III Ovarian Epithelial CancerStage III Ovarian Germ Cell TumorStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorNCT00436254University of Washington66
已完成
1 期
Vaccine Therapy in Treating Patients With Epstein-Barr Virus-Related CancerHead and Neck CancerLymphoproliferative DisorderNonneoplastic ConditionLymphomaGastric CancerNCT01147991Cancer Research UK16
已完成
2 期
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic MelanomaStage IV MelanomaRecurrent MelanomaNCT00019448National Cancer Institute (NCI)
撤回
1 期
Vaccine Therapy in Treating Patients With Stage II, Stage IIIA, Stage IIIB, or Stage IVA Liver CancerLiver CancerNCT00093548Jonsson Comprehensive Cancer Center
Unknown
2 期
Vaccine Therapy and Celecoxib in Treating Patients With Metastatic Nasopharyngeal CancerHead and Neck CancerNCT00589186National Cancer Centre, Singapore35