Phase II Trial of CC-5013 (Lenalidomide, Revlimid®) in Patients With Cutaneous T-Cell Lymphoma
- 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.
- 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
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
NOTE: *At Northwestern University only, blood and tissue samples from 5-10 patients are
collected. Peripheral blood samples are analyzed for immune cell repertoire (CD4+, CD8+ T
cells, NK cells, NKT cells, CD4+, CD25+ T-regulatory cells, monocytes, and dendritic cell
subsets), cell surface molecules, and for TH1/TH2-associated cytokines, such as interleukin
(IL)-2, IL-4, IL-10, IL-12, interferon gamma, and tumor necrosis factor alpha, by flow
cytometry at baseline, day 15 of course 1, and at the end of course 1. Immunological
activation is assessed by analyzing surface expression of CD45RO and CTLA-4 on CD4+ and CD8+
T cells in blood and skin samples. Skin specimens are stored for future research studies on
predictive markers of lenalidomide activity.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate and duration of response
After all patients have progressed
Timothy M. Kuzel, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Stanford Cancer Center||Stanford, California 94305-5824|