NCT01799083Unknown1 期
Phase 1/2 Study of Decitabine Alone and/or in Combination With Chemotherapy and/or Cytokine Induced Killer Cell Transfusion in Patients With Relapsed or Refractory Solid Tumors and B Cell Lymphomas
Han weidong1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年12月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Response confirmed by non-investigational CT or MRI, or confirmed by biopsy
研究概览
简要总结
Determine alone or in combination with chemotherapy or autologous cytokine induced killer cells are effective and safe in the treatment of patients with relapsed and/or refractory solid tumors or B Cell lymphomas.
详细描述
The purpose of this study is to determine whether lower dose decitabine based therapy is safe and can effectively control tumor progression.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Solid Tumor
- •Histologically confirmed advanced solid tumor
- •1 to 3 prior treatment regimens
- •At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional computerized tomography (CT) scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per RECIST criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the subject may be eligible upon approval by the Medical Monitor
- •B Cell Lymphoma
- •Histologically or cytologically confirmed B Cell Lymphoma.
- •Patients must have had an initial diagnosis of B Cell NHL (including follicular, small lymphocytic, lymphoplasmacytoid, and marginal zone lymphoma), indolent disease that transformed to a more aggressive subtype, as previously described or patients may have mantle cell lymphoma.
- •Patients are required to have received prior chemotherapy (alone or combined with rituximab or other treatment) and are considered refractory to (defined as no response, or progression within 6 months of completing therapy) or intolerant of continued rituximab or other treatment.
- •Patients may have received up to a maximum of four prior unique chemotherapy regimens, including if not contra-indicated autologous stem-cell transplantation (ASCT).
- •For patients to enroll in the expanded dose group for lymphoma, patients must have measurable disease
排除标准
- •Disease Related
- •Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy, within 3 weeks prior to first dose or 6 weeks for antibody therapy
- •Radiation therapy or immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6 weeks is required); localized radiation therapy within 1 week prior to first dose
- •Subjects with prior brain metastases are permitted, but must have completed treatment and have no evidence of active central nervous system (CNS) disease for at least 4 weeks prior to first dose
- •For lymphoma patients; patients with prior stem cell transplant therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should not have evidence of moderate-to-severe GVHD.
- •Participation in an investigational therapeutic study within 3 weeks prior to first dose
- •Prior treatment with decitabine
- •Concurrent Conditions
- •Major surgery within 3 weeks prior to first dose
- •Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 3 months prior to first dose
- •Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose
- •Known or suspected HIV infection or subjects who are HIV seropositive
- •Active hepatitis A, B, or C infection
- •Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose
- •Ethical / Other
- •Female subjects who are pregnant or lactating
- •Any clinically significant psychiatric or medical condition that in the opinion of the Investigator could interfere with protocol adherence or a subject's ability to give informed consent
研究组 & 干预措施
Decitabine
Experimental
A continuous 5-day treatment of lower dose decitabine within 4-6 weeks is regarded as a treatment cycle, transfusion of auto-CIK cells or chemotherapy regimen may be used for patients.
干预措施: Decitabine (Drug)
Decitabine
Experimental
A continuous 5-day treatment of lower dose decitabine within 4-6 weeks is regarded as a treatment cycle, transfusion of auto-CIK cells or chemotherapy regimen may be used for patients.
干预措施: cytokine-induced killer cell (Biological)
结局指标
主要结局
Response confirmed by non-investigational CT or MRI, or confirmed by biopsy
时间窗: within the first 30 days after four-cycle treatment
次要结局
- tumor marker(at least once within 30 days afther completing four-cycle treatment)
研究者
Han weidong
Researcher
Chinese PLA General Hospital
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Decitabine, Donor Natural Killer Cells, and Aldesleukin in Treating Patients With Relapsed or Refractory Acute Myeloid LeukemiaAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Recurrent Adult Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaNCT02316964Sumithira Vasu8
终止
1 期
Phase I/II: Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETsGliomasMedulloblastomaNeuroectodermal Tumors, PrimitiveNCT02332889University of Louisville1
已完成
1 期
A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT00861874University of Rochester13
已完成
1 期
Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDSPreviously Treated Myelodysplastic SyndromeRecurrent Adult Acute Myeloid LeukemiaRecurrent High Risk Myelodysplastic SyndromeRefractory Acute Myeloid LeukemiaRefractory High Risk Myelodysplastic SyndromeUntreated Adult Acute Myeloid LeukemiaMixed Phenotype Acute LeukemiaNCT02921061Fred Hutchinson Cancer Center28
Unknown
2 期
DC-CIK In Combination With Chemotherapy ( Gio / Oxaliplatin or Cisplatin ) Versus First-line Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Randomized Controlled Phase II Clinical Study of TreatmentGastric CancerNCT02504229Beijing Biohealthcare Biotechnology Co.,Ltd80