Status:
COMPLETED
Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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...
Detailed 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 sur...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 19 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00466921
Start Date
April 19 2005
End Date
May 17 2013
Last Update
December 1 2020
Active Locations (3)
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1
Stanford Cancer Center
Stanford, California, United States, 94305-5824
2
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
3
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009