Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With MF With Variable CD30 Expression Level
Cutaneous T Cell Lymphoma
Drug: Brentuximab vedotin
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level|
- Objective clinical response rate assessed by the standard response criteria used in MF (Mycosis fungoides) and SS (Sezary syndrome) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
|Experimental: SGN-35 arm||
Drug: Brentuximab vedotin
1.8 mg/kg; IV
Other Name: Adcetris
The purpose of this study is to learn the effects of an investigational medication, SGN 35, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting.
The primary objective is to explore the biologic activity of brentuximab vedotin (SGN-35) in patients with mycosis fungoides (MF) and Sézary syndrome (SS), the most common types of cutaneous T-cell lymphoma (CTCL), where expression of CD30 is variable. SGN-35 has significant biologic activity in Hodgkin's disease (HD) where only a small numbers of CD30 positive tumor cells are present, as well as in lymphomas with large numbers of CD30-expressing tumor cells such as systemic anaplastic large cell lymphoma (sALCL).
This phase II exploratory study will evaluate the clinical response of brentuximab vedotin (SGN-35) in MF and SS where tumor cells express variable levels of CD30 target molecule. The grouping by CD30 expression levels (low, intermediate, high) is for accrual purposes only to ensure a wide range of CD30 expression. Given the exploratory nature of this study, it will be open-label, single-arm, and non-randomized trial.
One centers will be involved to complete the accrual, a total of 24 patients with MF and SS. Enrollment will be based on CD30 expression levels by tissue immunohistochemistry (IHC), defined as low, intermediate or high expressers. The investigators will target 8 patients in each group for total of 24 patients. Of these 8 patients per group, up to 3 may be patients with SS.
Each patient regardless of CD30 expression level will receive 1.8 mg/kg of SGN-35 IV every 21 days, up to 8 cycles of therapy. Patients with CR may receive 2 additional cycles. Patients who have PR may receive up to a maximum of 16 doses IF they are continuing to improve after 8 cycles. Patients who relapse within 6 months after CR maybe eligible for retreatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396070
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Youn H Kim||Stanford University|