Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma
M.D. Anderson Cancer Center
Summary
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.
Description
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. III. To determine whether CD30+ expression levels in tumor tissue correlate to response to brentuximab vedotin. EXPLORATOR…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care * Female subject is either: a. post-menopausal for at least one year before the screening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 an…
Interventions
- DrugBrentuximab Vedotin
Given IV
- OtherLaboratory Biomarker Analysis
Correlative studies
Location
- M D Anderson Cancer CenterHouston, Texas