Clinical Trial: Everolimus in Treating Cutaneous T-cell Lymphoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: PHASE II TRIAL OF THE mTOR INHIBITOR EVEROLIMUS IN RELAPSED OR REFRACTORY CUTANEOUS T-CELL LYMPHOMA (CTCL)

Brief Summary: CTCL is a rare form of lymphoma of the skin. While early stages are usually confined to the skin, later stages may spread to blood, lymph nodes and other organs. At this point, patients usually require systemic chemo. This study will investigate the effect of everolimus as treatment for recurrent or refractory CTCL. Participation in this study will last as long as the study doctor believes disease has not gotten worse, and patients continue to tolerate the study medication for a maximum of 1 year. Once off the treatment, patients will be followed for two years.

Detailed Summary:

Cutaneous T-cell lymphoma is a rare form of lymphoma of the skin. While early stages are usually confined to the skin, later stages may spread to blood, lymph nodes and other organs. At this point, patients usually require systemic chemotherapy. This study will investigate the effect of everolimus as a treatment for patients diagnosed with CTCL that has either not responded to previous treatments or has recurred despite previous treatments. Everolimus is the common name for the commercial drug Afinitor® (Novartis). It is approved by the U.S. Food and Drug Administration (FDA) for use in kidney and brain cancer. In several different forms of lymphomas, everolimus is used as an investigational drug, which means it has not been approved by the FDA for this group of diseases.

Everolimus blocks a protein (mTOR) that helps cells and tumors to grow. Earlier studies have indicated that the drug everolimus may work against lymphomas including cutaneous T-cell lymphomas. Participation in this study will last as long as the study doctor believes disease has not gotten worse, and patients continue to tolerate the study medication for a maximum of 1 year. Once off the treatment, patients will be followed for two years.


Sponsor: Adam Lerner

Current Primary Outcome: Efficacy of Treatment [ Time Frame: 12 months after beginning treatment ]

Determine the efficacy of everolimus in the treatment of CTCL as overall response rate (ORR)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to Response [ Time Frame: three months ]
    Determine time to response (TTR)/duration of objective response (DOR)
  • Progression-free Survival [ Time Frame: two years after discontinuing study treatment ]
    Determine progression-free survival of CTCL patients treated with everolimus
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to one year ]
    Determine the adverse event profile and tolerability of everolimus in patients with CTCL
  • Effect of mTOR on Tumors [ Time Frame: one year ]
    Determine mTOR (mammilian target of rapamycin) pathway activation and number of regulatory T cells (Tregs) in pre-treated tumor tissue and evaluate changes following treatment


Original Secondary Outcome:

  • Time to Response [ Time Frame: three months ]
    Determine time to response (TTR)/duration of objective response (DOR)
  • Progression-free Survival [ Time Frame: two years after discontinuing study treatment ]
    Determine progression-free survival of CTCL patients treated with everolimus
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to one year ]
    Determine the adverse event profile and tolerability of everolimus in patients with CTCL
  • Effect of mTOR on Tumors [ Time Frame: one year ]
    Determine mTOR pathway activation and number of regulatory T cells (Tregs) in pre-treated tumor tissue and evaluate changes following treatment


Information By: Boston Medical Center

Dates:
Date Received: April 2, 2012
Date Started: June 2012
Date Completion:
Last Updated: November 25, 2016
Last Verified: November 2016