This trial is active, not recruiting.

Condition lymphoma
Treatment lenalidomide
Phase phase 2
Sponsor Northwestern University
Collaborator National Cancer Institute (NCI)
Start date February 2005
End date February 2016
Trial size 35 participants
Trial identifier NCT00466921, NU 04H5, NU-04H5, P30CA060553


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
10 mg daily orally administered on days 1 - 21 followed by 7 days rest of a 28-day cycle, increasing dose by 5 mg every cycle, up to a maximum of 25 mg.

Primary Outcomes

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

Secondary Outcomes

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.

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed mycosis fungoides/Sézary syndrome - Stage IA-IVB disease - Must have failed ≥ 1 prior topical treatment, including any of the following: - Steroids - Nitrogen mustard - Retinoids - Phototherapy - Photochemotherapy - Radiotherapy - Total skin electron beam - Measurable disease with ≥ 1 indicator lesion designated prior to study entry - Erythrodermic patients are eligible PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - WBC ≥ 3,000/mm³ - ANC ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Creatinine ≤ 2.0 mg/dL - Bilirubin ≤ 2.2 mg/dL - AST and ALT ≤ 2 times upper limit of normal - Not pregnant or nursing - Negative pregnancy test - Fertile women must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy - Fertile men must use effective contraception during and for ≥ 4 weeks after completion of study therapy - No other malignancy within the past 5 years except treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, or surgically removed melanoma in situ of the skin (stage 0), with histologically confirmed free margins of excision and no current evidence of disease - No acute infection requiring systemic treatment - No known allergic reaction or hypersensitivity to thalidomide PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 4 weeks since prior topical therapy, systemic chemotherapy, or biological therapy - No prior stem cell transplantation - No other concurrent systemic antipsoriatic or anticancer therapies, including radiotherapy, thalidomide, or other investigational agents - No other concurrent topical agents except emollients

Additional Information

Official title Phase II Trial of CC-5013 (Lenalidomide, Revlimid®) in Patients With Cutaneous T-Cell Lymphoma
Description 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 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Northwestern University.