RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with relapsed or refractory advanced mycosis fungoides or Sézary syndrome.
OBJECTIVES: * Determine the response rate of patients with relapsed or recurrent advanced mycosis fungoides or Sézary syndrome treated with alemtuzumab. * Determine the toxicity of this drug in these patients. OUTLINE: Patients receive alemtuzumab IV over 2 hours three times per week. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Will be administered as a two-hour IV infusion with a target dose of 30 milligrams three times a week for a maximum of 12 weeks.
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States
Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome
Response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome will be assessed by medical photograph (skin lesion) measurements or by CT scan for internal lesions upon study entry, weekly while on study, then once when patient goes off study
Time frame: At baseline, weekly while on treatment, then once when patient goes off study
Collect data on toxicity associated with Campath-1H therapy
Toxicity of this drug will be assessed upon study entry and then every 2 weeks while on therapy by blood tests
Time frame: At baseline and then every 2 weeks while on therapy
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