Spots Global Cancer Trial Database for Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome
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Trial Identification
Brief Title: Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome
Official Title: Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome
Study ID: NCT00157274
Interventions
Study Description
Brief Summary: The investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy.
Detailed Description: * 20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks. * Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and until three different regimens of chemotherapy. * Follow up for one year after last cycle of alemtuzumab.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Schering Peruana S.A., Lima, , Peru
Contact Details
Name: Brady E Beltran, MD
Affiliation: LACOGH - PERU
Role: PRINCIPAL_INVESTIGATOR
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