Clinical Trial: Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level

Brief Summary: The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, 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.

Detailed Summary:

This phase 2 exploratory study will evaluate the clinical response of brentuximab vedotin in MF and SS, where tumor cells express variable levels of CD30 target molecule.

The primary objective is to explore the biologic activity of brentuximab vedotin in patients with MF and SS, the most common types of cutaneous T-cell lymphoma (CTCL), where expression of CD30 is variable. Brentuximab vedotin 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). The subject grouping by CD30 expression levels (low, intermediate, high) is for accrual purposes only, to ensure that a wide range of CD30 expression is studied.


Sponsor: Youn Kim

Current Primary Outcome: Overall Response Rate (ORR) [ Time Frame: 2 years ]

Overall response rate of brentuximab vedotin in this study population.


Original Primary Outcome: Objective clinical response rate assessed by the standard response criteria used in MF (Mycosis fungoides) and SS (Sezary syndromel) [ Time Frame: 4 weeks ]

Current Secondary Outcome:

  • Overall Stable Disease Rate [ Time Frame: 2 years ]

    Overall Stable Disease Rate (SD) in this study population.

    3 subjects were not evaluable.

  • Overall Partial Response Rate [ Time Frame: 2 years ]

    Overall Partial Response Rate (PR) in this study population.

    3 subjects were not evaluable.

  • Overall Non-Evaluable Response [ Time Frame: 4 weeks ]

    Overall Non-Evaluable Response of full patient population

    3 subjects were not evaluable.



Original Secondary Outcome:

Information By: Stanford University

Dates:
Date Received: July 14, 2011
Date Started: May 2011
Date Completion:
Last Updated: February 17, 2017
Last Verified: February 2017