Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Disease control rate (DCR) defined as proportion of patients who had complete response, partial response or stable disease by Response Evaluation Criteria in Solid Tumors version 4.1
研究概览
简要总结
This phase II trial studies how well brentuximab vedotin works in treating patients with CD30 positive (+) malignant mesothelioma that cannot be removed by surgery. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of tumor cells to grow and spread.
详细描述
PRIMARY OBJECTIVES:
I. To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable malignant pleural mesothelioma (MPM) treated with brentuximab vedotin.
SECONDARY OBJECTIVES:
I. To evaluate the response rate, progression-free and overall survival, and safety/toxicity of brentuximab vedotin in CD30+ malignant mesothelioma.
II. To prospectively evaluate the incidence of CD30+ expression in malignant mesothelioma during the screening process.
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
- •Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- •Female subject is either: a. post-menopausal for at least one year before the screening visit; or b. surgically sterilized; or c. 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 at least 6 months after the last dose of brentuximab vedotin
- •Male subject, even if surgically sterilized (i.e., status postvasectomy), agrees to use an acceptable barrier method for contraception (condom with a spermicidal agent), or completely abstain from heterosexual intercourse during the entire study treatment period through 6 months after the last dose of brentuximab vedotin
- •Absolute neutrophil count (ANC) > 1500/mm^3
- •Platelets > 100,000/mm^3
- •Hemoglobin (Hgb) > 8.5 g/dL
- •Total bilirubin =< 1.5 x upper limit of normal (ULN)
- •Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x ULN; AST and/or ALT may be up to 5 X ULN if with known liver metastases (mets)
- •Calculated creatinine clearance must be >= 30 mL/minute
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable, any histology is acceptable)
- •Have unresectable malignant mesothelioma (any histology)
- •Positive CD30+ immunohistochemical expression
- •Any line of prior therapy - patients may be chemo-naive or chemo-refractory (any line)
- •Patients must have measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) or RECIST; examinations for assessment of measurable disease must have been completed within 28 days prior to registration
排除标准
- •Radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%
- •Prior allogeneic bone marrow or organ transplantation
- •Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
- •Patient has received other investigational drugs with 14 days before enrollment
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •No prior history of malignancy within 2 years, unless cured of a skin cancer or a stage I-III solid tumor; no prior hematologic malignancy within 3 years
- •Known hypersensitivity to brentuximab vedotin components
- •Persons who are incarcerated at time of enrollment (e.g., prisoners) or likely to become incarcerated during the study
研究组 & 干预措施
Treatment (brentuximab vedotin)
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (brentuximab vedotin)
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Brentuximab Vedotin (Drug)
结局指标
主要结局
Disease control rate (DCR) defined as proportion of patients who had complete response, partial response or stable disease by Response Evaluation Criteria in Solid Tumors version 4.1
时间窗: At 4 months
A DCR of 50% or higher is considered as clinically significant. If the trial is not stopped early and all 50 patients are accrued, point estimate along with 95% credible interval will be provided. Logistic regression model will be utilized to assess the effect of patient prognostic factors on the response status if sufficient number of patients with stable disease or better response to the treatment are observed.
次要结局
- Tumor characteristics(Up to 5 years)
- Time to progression(Up to 5 years)
- Overall survival(Up to 5 years)
- CD30+ expression levels(Up to 5 years)