Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03007030|
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|CD30-Positive Neoplastic Cells Present Malignant Mesothelioma||Drug: Brentuximab Vedotin Other: Laboratory Biomarker Analysis||Phase 2|
I. To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable malignant pleural mesothelioma (MPM) treated with brentuximab vedotin.
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.
III. To determine whether CD30+ expression levels in tumor tissue correlate to response to brentuximab vedotin.
I. To collect archival or new tissue and blood for correlative studies. II. Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens.
III. Exploratory analysis: Bank peripheral blood at baseline for subsequent cytokine or reverse phase protein array (RPPA).
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, 3 months, 6 months and then every 6 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma|
|Actual Study Start Date :||April 5, 2017|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||April 30, 2022|
Experimental: 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.
Drug: Brentuximab Vedotin
Other: Laboratory Biomarker Analysis
- 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 [ Time Frame: 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.
- Tumor characteristics [ Time Frame: Up to 5 years ]Patients' demographic and tumor characteristics will be analyzed, with categorical variables summarized in frequency tables while continuous variables summarized using mean (plus or minus standard deviation) and median (range). The student t-test/Wilcoxon test and analysis of variance (ANOVA)/Kruskal-Wallis test will be used to compare continuous variables between different patient groups. The chi-square test or the Fisher's exact test will be applied to assess the association between two categorical variables.
- Time to progression [ Time Frame: Up to 5 years ]The distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important patient characteristics will be made using the log-rank test. Cox proportional hazard regression will be employed for multi-covariate analysis on time-to-event outcomes when appropriate.
- Overall survival [ Time Frame: Up to 5 years ]The distribution of time-to-event endpoints will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important patient characteristics will be made using the log-rank test. Cox proportional hazard regression will be employed for multi-covariate analysis on time-to-event outcomes when appropriate.
- CD30+ expression levels [ Time Frame: Up to 5 years ]The student t-test/Wilcoxon test and ANOVA/Kruskal-Wallis test will be used to compare CD30+ expression levels by response status.
- Cytokines in peripheral blood [ Time Frame: At time of disease progression, assessed up to 5 years ]Appropriate statistical approaches will be applied to the exploratory analysis of the cytokines.
- Reverse phase protein array (RPPA) in peripheral blood [ Time Frame: At time of disease progression, assessed up to 5 years ]Appropriate statistical approaches will be applied to the exploratory analysis of RPPA.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007030
|Contact: Anne S. Tsaofirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Anne S. Tsao 713-792-6363|
|Principal Investigator: Anne S. Tsao|
|Principal Investigator:||Anne S Tsao||M.D. Anderson Cancer Center|