Trial of Adcetris in CD30+ Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT03007030|
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : December 25, 2018
The goal of this clinical research study is to learn if Adcetris (brentuximab vedotin) can help to control mesothelioma. The safety of this drug will also be studied.
This is an investigational study. Brentuximab vedotin is FDA approved and commercially available for the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma. It is considered investigational to use brentuximab vedotin in patients with mesothelioma. The study doctor can explain how the study drug is designed to work.
Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Lung Diseases Due to External Agents Mesothelioma||Drug: Brentuximab Vedotin||Phase 2|
Study Drug Administration:
There are 21 days (about 3 weeks) in each study cycle.
If you are found to be eligible to take part in this study, you will receive brentuximab vedotin by vein over about 30 minutes on Day 1 of every cycle.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on this study will be over after you have completed follow-up (described below).
On Day 1 of every cycle:
- You will have a physical exam
- Blood (about 4 teaspoons) will be drawn for routine tests
Every 6 weeks while you are on study, you will have a PET-CT scan to check the status of the disease.
The study doctor or study team will follow you up with you about 30 days after your last dose of brentuximab vedotin by either reviewing your medical record or calling you to learn if you have had any side effects.
You will continue to have these follow-ups at 3 months, 6 months, and then every 6 months after that while you are on study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 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 2022|
|Estimated Study Completion Date :||April 2022|
Experimental: Brentuximab Vedotin
Participants receive Brentuximab Vedotin by vein on Day 1 of every 21 Day cycle.
Participants remain on trial until unacceptable toxicity, withdrawal of consent, or disease progression.
Drug: Brentuximab Vedotin
Starting Dose: 2.4 mg/kg by vein over 30 minutes on Day 1 of each 21 Day cycle.
Brentuximab vedotin capped at a maximum dose of 240 mg.
- Disease Control Rate (DCR) in Pre-Treated Participants with Unresectable Malignant Pleural Mesothelioma (MPM) Treated with Brentuximab Vedotin [ Time Frame: 4 months ]Disease control rate (DCR) defined as proportion of patients who had complete response, partial response or stable disease by RESIST 4.1.
- Time to Progression in Pre-Treated Participants with Unresectable Malignant Pleural Mesothelioma (MPM) Treated with Brentuximab Vedotin [ Time Frame: 6 weeks ]
Time to progression assessed by RESIST 4.1.
Time to progression estimated using the method of Kaplan and Meier.
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. Tsao, MDemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anne S. Tsao, MD||M.D. Anderson Cancer Center|