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