Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome
Condition: Lymphoma
MeSH terms: Mycoses; Lymphoma; Mycosis Fungoides; Sezary Syndrome
Intervention: lenalidomide
Intervention description: 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.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent mycosis fungoides/Sezary syndrome; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome

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.
    

Eligibility criteria:

        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