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

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Seattle Genetics, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Brentuximab Vedotin; Immunoconjugates; Immunoglobulins

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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