The goal of this clinical research study is to learn if Adcetris (brentuximab vedotin) can help to control mesothelioma. The safety of this drug will also be studied.
|First Received Date||December 28, 2016|
|Last Changed Date||June 12, 2017|
|Start Date||April 5, 2017|
|Anticipated Primary Completion Date||April 2022|
|Primary Outcome Measures||
Disease Control Rate (DCR) in Pre-Treated Participants with Unresectable Malignant Pleural Mesothelioma (MPM) Treated with Brentuximab Vedotin [Time Frame: 4 months]
|Secondary Outcome Measures||
Time to Progression in Pre-Treated Participants with Unresectable Malignant Pleural Mesothelioma (MPM) Treated with Brentuximab Vedotin [Time Frame: 6 weeks]
|Study Arms / Comparison Groups||1 / 0|
Study Drug Administration:
There are 21 days (about 3 weeks) in each study cycle.
If you are found to be eligible to take part in this study, you will receive brentuximab vedotin by vein over about 30 minutes on Day 1 of every cycle.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on this study will be over after you have completed follow-up (described below).
On Day 1 of every cycle:
- You will have a physical exam
- Blood (about 4 teaspoons) will be drawn for routine tests
Every 6 weeks while you are on study, you will have a PET-CT scan to check the status of the disease.
The study doctor or study team will follow you up with you about 30 days after your last dose of brentuximab vedotin by either reviewing your medical record or calling you to learn if you have had any side effects.
You will continue to have these follow-ups at 3 months, 6 months, and then every 6 months after that while you are on study.
This is an investigational study. Brentuximab vedotin is FDA approved and commercially available for the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma. It is considered investigational to use brentuximab vedotin in patients with mesothelioma. The study doctor can explain how the study drug is designed to work.
Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
Anne S. Tsao, MD
1. 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.
2. 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 (ie, 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.
3. Male subject, even if surgically sterilized (ie, 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.
4. Absolute neutrophil count (ANC) > 1500/mm³, platelets > 100,000/mm³, Hgb > 8.5 g/dL.
5. Total bilirubin = 1.5 x upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) < 3 x ULN. AST and/or ALT may be up to 5X ULN if with known liver mets
6. Adequate renal function as defined by: Calculated creatinine clearance must be >/= 30 mL/minute
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
8. Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable, any histology is acceptable)
9. Have unresectable malignant mesothelioma (any histology)
10. Positive CD30+ immunohistochemical expression
11. Any line of prior therapy - patients may be chemo-naïve or chemo-refractory (any line)
12. Patients must have measurable disease by modified RECIST or RECIST. Examinations for assessment of measurable disease must have been completed within 28 days prior to registration.
13. Patient must be >/= 18 years of age
1. Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is considered to be over 25%.
2. Prior allogeneic bone marrow or organ transplantation
3. 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.
4. Patient has received other investigational drugs with 14 days before enrollment
5. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
6. 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.
7. Known hypersensitivity to brentuximab vedotin components
8. Persons who are incarcerated at time of enrollment (e.g., prisoners) or likely to become incarcerated during the study
|Sponsor||M.D. Anderson Cancer Center|
|Verification Date||June 2017|