Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome
- Conditions
- Lymphoma
- Interventions
- Biological: alemtuzumab
- Registration Number
- NCT00057967
- Lead Sponsor
- Northwestern University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm alemtuzumab alemtuzumab
- Primary Outcome Measures
Name Time Method Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome At baseline, weekly while on treatment, then once when patient goes off study 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
Collect data on toxicity associated with Campath-1H therapy At baseline and then every 2 weeks while on therapy Toxicity of this drug will be assessed upon study entry and then every 2 weeks while on therapy by blood tests
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
Northwestern University, Northwestern Medical Faculty Foundation
🇺🇸Chicago, Illinois, United States