Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: alemtuzumab


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed mycosis fungoides or Sézary syndrome Stage IB-IVB Measurable disease One or more indicator lesions No prior radiotherapy to areas of measurable disease unless there is clear disease progression at the site or measurable disease outside the area of prior radiotherapy Generalized erythrodermia patients with evaluable disease only are allowed Must have failed at least 1 prior systemic therapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR WHO 0-2 Life expectancy At least 3 months Hematopoietic WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2.2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal Creatinine no greater than 2.0 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No acute infection requiring intravenous antibiotics No other prior neoplasm except treated squamous cell or basal cell skin cancer, treated carcinoma in situ of the cervix, or other cancer that received surgical treatment only from which patient has been disease free for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior biologic therapy Chemotherapy More than 4 weeks since prior chemotherapy Endocrine therapy More than 4 weeks since prior topical steroids Radiotherapy See Disease Characteristics At least 2 weeks since prior radiotherapy (local control or palliative) No concurrent radiotherapy to any lesion Surgery Recovered from prior major surgery Other Recovered from prior therapy No other concurrent proven or investigational antineoplastic agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>alemtuzumab | Biological: alemtuzumab<br>* 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.<br>* Other names: Campath-1H;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | At baseline and then every 2 weeks while on therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent mycosis fungoides/Sezary syndrome, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent cutaneous T-cell non-Hodgkin lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma