Clinical Trial: SGN-35 in CD30-positive Lymphoproliferative Disorders (ALCL), Mycosis Fungoides (MF), and Extensive Lymphomatoid Papulosis (LyP)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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), My

Brief Summary: The goal of this clinical research study is to learn if SGN-35 (brentuximab vedotin) can help to control ALCL, LyP or MF in patients with at least 1 of the 3 skin lymphomas. The safety of the study drug will also be studied.

Detailed Summary:

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
  Sponsor: M.D. Anderson Cancer Center
  

  Current Primary Outcome: Response Rate [ Time Frame: 12 months ]

  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.
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome: Time to Progression [ Time Frame: Assessments through 8 treatment cycles (21 day cycle, approximately 6 months) with possible expansion to 16 cycles, up to 2 years. ]

  Time to progression calculated as the time (days) from date of first dose of study drug to date of first observed progression or death date if the death was due to disease progression whichever comes first.
  
  
  

  Original Secondary Outcome:
  
  Information By: M.D. Anderson Cancer Center
  

  Dates:
  Date Received: May 10, 2011
  Date Started: June 2011
  Date Completion: June 2018
  Last Updated: May 2, 2017
  Last Verified: May 2017