Actively Recruiting
Phase II Trial of Brentuximab Vedotin in CD30 Positive Malignant Mesothelioma That Cannot Be Removed by Surgery
Led by M.D. Anderson Cancer Center · Updated on 2026-05-15
55
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating how well brentuximab vedotin works in treating patients with CD30 positive malignant mesothelioma that cannot be removed by surgery. This phase II trial focuses on patients with unresectable malignant pleural mesothelioma who have been previously treated. The study aims to assess disease control rate, response rate, survival outcomes, safety, and to explore the relationship between CD30 expression and treatment response. Additional exploratory analyses include tissue and blood sample studies using advanced genetic sequencing and protein analysis techniques. Participants receive brentuximab vedotin through an intravenous infusion over 30 minutes on day 1 of each treatment cycle. These cycles repeat every 21 days unless the disease progresses or unacceptable side effects occur. The study also includes correlative laboratory biomarker analysis. After completing treatment, patients are followed up at 30 days, 3 months, 6 months, and then every 6 months for ongoing monitoring. During the trial, participants will undergo regular assessments to evaluate tumor response using standard criteria, along with monitoring overall survival, progression, and safety. Tissue and blood samples will be collected for biomarker studies. Follow-up visits continue up to five years to track long-term outcomes. The primary measure is disease control rate at four months, with secondary measures including tumor characteristics and CD30 expression levels.
CONDITIONS
Brief 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...
- Provide voluntary written informed consent before any study-related procedures
- Female participants must be post-menopausal for at least one year, surgically sterilized, or willing to use reliable birth control during the study and for 6 months after last dose
- Male participants must use barrier contraception or abstain from heterosexual intercourse during treatment and for 6 months after last dose
- Absolute neutrophil count greater than 1500/mm³
- Platelet count greater than 100,000/mm³
- Hemoglobin level greater than 8.5 g/dL
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- Liver enzymes (AST and ALT) less than 3 times upper limit of normal, or up to 5 times if liver metastases are present
- Creatinine clearance at least 30 mL/minute
- ECOG performance status between 0 and 2
- Pathologic diagnosis of malignant mesothelioma with unresectable disease
- Positive CD30 expression confirmed by immunohistochemistry
- Any prior therapy allowed, including chemo-naive and chemo-refractory
- Measurable disease by RECIST criteria 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
- Pregnant or breastfeeding women; negative pregnancy test required for women of childbearing potential
- Use of other investigational drugs within 14 days prior to enrollment
- Serious medical or psychiatric illness that could 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 allergy to brentuximab vedotin components
- Incarcerated persons or those likely to become incarcerated during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive brentuximab vedotin intravenously over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1 visit every 21 days for treatment administration
Duration - Up to 5 years
Participants are followed up after completion of study treatment to monitor their health and any long-term effects.
Visits at 30 days, 3 months, 6 months, and every 6 months thereafter
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
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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