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Brentuximab Vedotin for CD30+ Malignant Mesothelioma

This study is testing a drug called brentuximab vedotin in people with malignant mesothelioma (a type of cancer that forms in the lining of the lungs, abdomen, or heart) that has a specific marker called CD30+ and cannot be removed by surgery. Researchers want to see how well brentuximab vedotin controls the disease after 4 months. The drug works by targeting tumor cells to stop them from growing and spreading. You may be able to join if you are 18 or older and have CD30+ malignant mesothelioma. The study is currently active, but its exact status is unclear.

Study design
This study plans to enroll 55 participants and is testing brentuximab vedotin in a single group.
What's involved
Participants will receive brentuximab vedotin intravenously (through a vein) every 21 days until their disease gets worse or side effects are too severe.
Compensation
Not stated in the trial record.
Follow-up
After treatment, participants will have follow-up visits at 30 days, 3 months, 6 months, and then every 6 months after that.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03007030

Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~25 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Brentuximab VedotinLaboratory Biomarker Analysis

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease control rate (DCR) defined as proportion of patients who had complete response, partial response or stable disease by Response Evaluation Criteria in Solid Tumors version 4.1
Measured over At 4 months

Conditions

CD30-Positive Neoplastic Cells Present
Malignant Mesothelioma

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Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Anne S Tsao · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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 and at least 6 months after the last dose of brentuximab vedotin
Male subject, even if surgically sterilized (i.e., status postvasectomy), agrees to use an acceptable barrier method for contraception (condom with a spermicidal agent), or completely abstain from heterosexual intercourse during the entire study treatment period through 6 months after the last dose of brentuximab vedotin
Absolute neutrophil count (ANC) \> 1500/mm\^3
Platelets \> 100,000/mm\^3
Hemoglobin (Hgb) \> 8.5 g/dL
Total bilirubin =\< 1.5 x upper limit of normal (ULN)
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 3 x ULN; AST and/or ALT may be up to 5 X ULN if with known liver metastases (mets)
Calculated creatinine clearance must be \>= 30 mL/minute
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable, any histology is acceptable)
Have unresectable malignant mesothelioma (any histology)
Positive CD30+ immunohistochemical expression
Any line of prior therapy - patients may be chemo-naive or chemo-refractory (any line)
Patients must have measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) or RECIST; examinations for assessment of measurable disease must have been completed within 28 days prior to registration

Exclusion

Radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%
Prior allogeneic bone marrow or organ transplantation
Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
Patient has received other investigational drugs with 14 days before enrollment
Serious medical or psychiatric illness likely to interfere with participation in this clinical study
No prior history of malignancy within 2 years, unless cured of a skin cancer or a stage I-III solid tumor; no prior hematologic malignancy within 3 years
Known hypersensitivity to brentuximab vedotin components
Persons who are incarcerated at time of enrollment (e.g., prisoners) or likely to become incarcerated during the study

What this trial measures

  • Disease control rate (DCR) defined as proportion of patients who had complete response, partial response or stable disease by Response Evaluation Criteria in Solid Tumors version 4.1At 4 months

    A DCR of 50% or higher is considered as clinically significant. If the trial is not stopped early and all 50 patients are accrued, point estimate along with 95% credible interval will be provided. Logistic regression model will be utilized to assess the effect of patient prognostic factors on the response status if sufficient number of patients with stable disease or better response to the treatment are observed.