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Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome
Not Recruiting
Trial ID: NCT00466921
Purpose
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
Clinical Associate Professor, Medicine - Oncology
Richard Hoppe
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Eligibility
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
Intervention(s):
drug: lenalidomide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Natalie Viakhireva
6507238949