Actively Recruiting
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
Led by M.D. Anderson Cancer Center · Updated on 2025-11-10
55
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent before any study-related procedure
- Female subjects must be post-menopausal for at least one year, surgically sterilized, or willing to use birth control during the study and for 6 months after last dose
- Male subjects must use barrier contraception or abstain from heterosexual intercourse during the study and for 6 months after last dose
- Absolute neutrophil count (ANC) greater than 1500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin level greater than 8.5 g/dL
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- AST and ALT less than 3 times upper limit of normal (up to 5 times if liver metastases present)
- Creatinine clearance at least 30 mL/minute
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Pathologic diagnosis of malignant mesothelioma with any primary site or histology
- Unresectable malignant mesothelioma
- Positive CD30 immunohistochemical expression
- Any line of prior therapy, including chemo-naive or chemo-refractory
- Measurable disease by RECIST or modified RECIST within 28 days prior to registration
You will not qualify if you...
- Radiation therapy to more than 25% of bone marrow
- Prior allogeneic bone marrow or organ transplantation
- Female subjects who are pregnant or breastfeeding; negative pregnancy test required for women of childbearing potential
- Receipt of other investigational drugs within 14 days before enrollment
- Serious medical or psychiatric illness that may interfere with study participation
- History of malignancy within 2 years except cured skin cancer or stage I-III solid tumor; no hematologic malignancy within 3 years
- Known hypersensitivity to brentuximab vedotin components
- Persons who are incarcerated at time of enrollment or likely to become incarcerated during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Anne S. Tsao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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