Study on Brentuximab Vedotin for Treating CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03007030

Provider View

This clinical trial is testing how well the drug brentuximab vedotin works in treating patients with CD30 positive malignant mesothelioma that cannot be surgically removed. The drug is a type of monoclonal antibody that may help stop tumor cells from growing and spreading.

Patient Parameters

Program Overview

This phase II study is investigating the effectiveness of brentuximab vedotin in patients with CD30 positive malignant mesothelioma that cannot be removed by surgery. Brentuximab vedotin is a monoclonal antibody that may interfere with the growth and spread of tumor cells. The study aims to see if the drug can control the disease for at least four months in patients who have already received other treatments.

Description

The main goal of this study is to see if brentuximab vedotin can control malignant pleural mesothelioma (MPM) for at least four months in patients whose cancer cannot be removed by surgery and who have already been treated with other therapies.

Secondary goals include evaluating how well the cancer responds to the treatment, how long patients live without the disease getting worse, overall survival, and the safety of the drug. The study will also look at how often CD30 is present in mesothelioma tumors and whether the level of CD30 affects how well the drug works.

Exploratory goals involve collecting tissue and blood samples for further research, including next-generation sequencing and other analyses.

Patients in the study will receive brentuximab vedotin through an IV infusion over 30 minutes on the first day of each 21-day cycle. This will continue as long as the disease does not progress and the patient does not experience unacceptable side effects. After finishing the treatment, patients will have follow-up visits at 30 days, 3 months, 6 months, and then every 6 months.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate in the study.
  • Women must be post-menopausal, surgically sterilized, or agree to use birth control during the study and for 6 months after the last dose.
  • Men must agree to use a condom or abstain from sex during the study and for 6 months after the last dose.
  • Must have adequate blood cell counts and organ function as determined by specific blood tests.
  • Must have a confirmed diagnosis of malignant mesothelioma that cannot be removed by surgery.
  • Tumor must test positive for CD30.
  • Can have had any number of previous treatments, including chemotherapy.
  • Must have measurable disease based on specific medical criteria.

Exclusion Criteria

  • Have had radiation therapy to more than 25% of the bone marrow.
  • Have had a bone marrow or organ transplant.
  • Women who are pregnant or breastfeeding.
  • Have taken other experimental drugs within 14 days before joining the study.
  • Have a serious medical or mental health condition that could interfere with the study.
  • Have had another cancer within the past 2 years, unless it was a cured skin cancer or a stage I-III solid tumor.
  • Have had a blood cancer within the past 3 years.
  • Are allergic to any components of brentuximab vedotin.
  • Are currently incarcerated or likely to become incarcerated during the study.

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