Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome

Not Recruiting

Trial ID: NCT00466921


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.

Official Title

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

Stanford Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology



   - 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


   - 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


   - See Disease Characteristics

   - More than 4 weeks since prior topical therapy, systemic chemotherapy, or biological

   - 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


drug: lenalidomide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Natalie Viakhireva

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