Phase II Trial of Brentuximab Vedotin (SGN-35) at Dose of 1.8 mg/kg IV Every 3 Weeks in Patients With CD30-positive Lymphoproliferative Disorders (Cutaneous Anaplastic Large T-cell Lymphoma (ALCL), Mycosis Fungoides, and Extensive Lymphomatoid Papulosis (LyP)
The Study Drug:
Brentuximab vedotin is an antibody that is designed to find a certain protein (called CD30)
on cancer cells and bind to it. It is designed to then enter the cell and release a
molecule that may kill the cancer cells.
Study Drug Administration:
If you are found eligible to take part in this study, you will begin receiving brentuximab
vedotin by vein over 30 minutes on Day 1 of each 21-day study cycle. If you have side
effects after your first dose and your doctor thinks it is in your best interest, future
doses may be lowered or delayed for up to 3 weeks.
Premedications:
If you have any reactions at the infusion site after you receive the study drug during Cycle
1, you may be given acetaminophen (Tylenol) or diphenhydramine (Benadryl) 30-60 minutes
before all following infusions.
Study Visits:
At each clinic visit, including follow-up visits (described below), you will have full skin
exams. You will be checked to see how much of your skin's surface has lesions. Up to 6 skin
lesions will be selected to be photographed and measured at each visit. Your private areas
will be covered (as much as possible), and a picture of your face will not be taken unless
there are lesions on your face. You will not be able to be identified in the photographs.
The following tests and procedures will also be performed:
On Day 1 of all study cycles (before you receive the study drug):
- You will have a physical exam.
- Your performance status will be recorded.
- You will be asked about any drugs that you may be taking and if you are having any side
effects.
- You will fill out the 3 quality-of-life questionnaires.
- Blood (about 4-6 teaspoons) will be drawn for routine tests and to check the status of
the disease.
- If you have not had a lesion biopsy within the last 6 weeks you will have a lesion
biopsy to check the status of the disease and for PGx testing.
Length of Study Treatment:
You may receive the study drug for up to 8 cycles. You will be taken off study if the
disease gets worse or intolerable side effects occur.
If the disease has a complete response, you may receive the study drug for 2 more cycles if
the study doctor thinks it is in your best interest.
If the disease has complete response, then comes back, you may receive the study drug for 8
more cycles if the doctor thinks it is in your best interest.
If you are doing better at the end of 8 cycles but the disease is not in complete
remission, the study doctor may allow you to receive the study drug every 3 weeks at the
full dose or every 2 weeks at a lower dose for up to 8 additional cycles.
Follow-up Visits:
About 3-4 weeks after you have stopped taking the study drug, the following tests and
procedures will be performed:
- Your medical history will be recorded.
- Your performance status will be recorded.
- You will have a physical exam.
- You will be asked if you are having any side effects.
- You will fill out the 3 quality-of-life questionnaires.
- Blood (about 4-6 teaspoons) will be drawn for routine tests and to check the status of
the disease.
- You will have a CT or PET scan to check the status of the disease.
- You will have a lesion biopsy to check the status of the disease and for PGx testing.
About 6-8 weeks after you have stopped taking the study drug, the following tests and
procedures will be performed:
- You will have a physical exam.
- You will be asked about any side effects you may be having.
At 12 weeks after you have stopped taking the study drug and every 12 weeks after that
until the disease gets worse or the study is no longer open:
- You will have a physical exam.
- You will be asked about any side effects you may be having.
- Your medical history will be recorded.
This is an investigational study. Brentuximab vedotin is not FDA approved or commercially
available for use in patients with ALCL, LyP or MF. It is currently being used for research
purposes only.
Up to 84 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate
Response rate is percentage of participants with skin lesions that express CD30+ receiving SGN-35 in primary cutaneous ALCL, MF, and extensive lymphomatoid papulosis whose best response during the observation period is a Partial Response (PR), regression of measurable disease, or Complete Response (CR), complete disappearance of all clinical evidence of disease, (i.e. at least moderate improvement). Objective tumor response (PR, CR, PR+CR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
12 months
No
Madeleine Duvic, MD
Study Chair
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2010-0914
NCT01352520
June 2011
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |