Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
At baseline, weekly while on treatment, then once when patient goes off study
Timothy M. Kuzel, MD
United States: Federal Government
|Veterans Affairs Medical Center - Lakeside Chicago||Chicago, Illinois 60611|
|Northwestern University, Northwestern Medical Faculty Foundation||Chicago, Illinois 60611-3013|