Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
NCT ID: NCT03007030
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
55 participants
INTERVENTIONAL
2017-04-05
2026-05-01
Brief Summary
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Detailed Description
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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.
EXPLORATORY OBJECTIVES:
I. To collect archival or new tissue and blood for correlative studies. II. Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens.
III. Exploratory analysis: Bank peripheral blood at baseline for subsequent cytokine or reverse phase protein array (RPPA).
OUTLINE:
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, 3 months, 6 months and then every 6 months thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (brentuximab vedotin)
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Brentuximab Vedotin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Brentuximab Vedotin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Anne S Tsao
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Anne S. Tsao
Role: primary
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2017-00069
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-0514
Identifier Type: OTHER
Identifier Source: secondary_id
2016-0514
Identifier Type: -
Identifier Source: org_study_id