NCT03007030Active, not recruitingPhase 2
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 28 Dec 2016
- Start date
- 5 Apr 2017
- Primary completion date
- 1 May 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Mesothelioma, Lung cancer
- NCT number
- NCT03007030
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 25
- From 5 Apr 2017 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patient has received other investigational drugs with 14 days before enrollment
Other illness
- 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
Lab values
- 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
Other
- Persons who are incarcerated at time of enrollment (e.g., prisoners) or likely to become incarcerated during the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.