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

Launched by M.D. ANDERSON CANCER CENTER · Dec 28, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called brentuximab vedotin for patients with a type of cancer known as malignant mesothelioma that cannot be removed by surgery. Specifically, the trial focuses on patients whose cancer cells test positive for a marker called CD30. Brentuximab vedotin is a type of medication that helps target and stop the growth of cancer cells. The study is currently recruiting participants, and it is open to both men and women aged 65 to 74 who meet certain health criteria.

To be eligible for this trial, participants must have a confirmed diagnosis of malignant mesothelioma and must not have had successful surgery to remove their tumor. They should also have a specific level of healthy blood counts and be in good overall health, meaning they can manage normal activities. Women must be post-menopausal or use reliable birth control, and men must agree to use barrier contraception. Participants can expect regular check-ups and monitoring throughout the study to track how well the treatment is working. This trial not only aims to evaluate the effectiveness of brentuximab vedotin but also contributes to understanding how to better treat this challenging cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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 Criteria:
• • 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