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
- Brief Title: Trial of Adcetris in CD30+ Malignant Mesothelioma
- Official Title: Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma
Clinical Trial IDs
- ORG STUDY ID:
- SECONDARY ID:
- NCT ID:
- Lung Diseases Due to External Agents
|Brentuximab Vedotin||SGN-35, Adcetris||Brentuximab Vedotin|
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.
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
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
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.
|Brentuximab Vedotin||Experimental||Participants receive Brentuximab Vedotin by vein on Day 1 of every 21 Day cycle.
Participants remain on trial until unacceptable toxicity, withdrawal of consent, or disease progression.|
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
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
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
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
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|
Primary Outcome Measures
|Measure:||Disease Control Rate (DCR) in Pre-Treated Participants with Unresectable Malignant Pleural Mesothelioma (MPM) Treated with Brentuximab Vedotin|
|Time Frame:||4 months|
|Description:||Disease control rate (DCR) defined as proportion of patients who had complete response, partial response or stable disease by RESIST 4.1.|
Secondary Outcome Measures
|Measure:||Time to Progression in Pre-Treated Participants with Unresectable Malignant Pleural Mesothelioma (MPM) Treated with Brentuximab Vedotin|
|Time Frame:||6 weeks|
|Description:||Time to progression assessed by RESIST 4.1.
Time to progression estimated using the method of Kaplan and Meier.|
|Lead Sponsor:||M.D. Anderson Cancer Center|
- Lung Diseases Due to External Agents
- Unresectable malignant pleural mesothelioma
- Brentuximab vedotin
September 11, 2017