Clinical Trial: Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome

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

Official Title: Phase II Trial of CC-5013 (Lenalidomide, Revlimid®) in Patients With Cutaneous T-Cell Lymphoma

Brief Summary:

RATIONALE: Lenalidomide may stop the growth of mycosis fungoides/Sezary syndrome by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with relapsed mycosis fungoides/Sezary syndrome.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the response rate and duration of response in patients with relapsed mycosis fungoides/Sézary syndrome treated with lenalidomide.
  • Determine the progression-free survival of patients treated with this drug.

Secondary

  • Determine the toxicity of this drug in these patients.
  • Correlate the antiangiogenetic and costimulatory effects of this drug with clinical activity in skin biopsies from these patients.
  • Assess the specific immune effector cell recruitment and augmentation of antitumor response in these patients. (Northwestern University only)

OUTLINE: This is a multicenter study.

Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 2 courses. Patients with progressive disease are removed from study. Patients achieving complete response receive 2 additional courses of treatment beyond complete response. Patients achieving partial response or stable disease may continue to receive lenalidomide as above for up to 2 years. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients undergo tissue biopsies at baseline and on day 1 of course 2. Tissue specimens are analyzed for vessel density, presence of adhesion molecules, and immunophenotyping of dermal infiltrate.*

NOTE: *At Northwestern University only, blood and tissue samples from 5-10 patients
Sponsor: Northwestern University

Current Primary Outcome:

  • Response rate and duration of response [ Time Frame: After all patients have progressed ]
  • Progression-free survival [ Time Frame: After all patients have progressed or become deceased ]


Original Primary Outcome:

  • Response rate and duration of response
  • Progression-free survival


Current Secondary Outcome:

  • Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Up to 30 days after the last patient receives the last study treatment. ]
  • Correlation of antiangiogenetic and costimulatory effects with clinical activity at baseline and after course 1 [ Time Frame: After all patients have completed 1 course ]
  • Specific immune effector cell recruitment and augmentation of antitumor response at baseline and day 15 of course 1 (Northwestern University only) [ Time Frame: After all patients have completed thru day 15 of course 1. ]


Original Secondary Outcome:

  • Toxicity as assessed by NCI CTCAE v3.0
  • Correlation of antiangiogenetic and costimulatory effects with clinical activity at baseline and after course 1
  • Specific immune effector cell recruitment and augmentation of antitumor response at baseline and day 15 of course 1 (Northwestern University only)


Information By: Northwestern University

Dates:
Date Received: April 25, 2007
Date Started: February 2005
Date Completion: February 2018
Last Updated: May 5, 2016
Last Verified: May 2016