alemtuzumab in treating patients with relapsed or refractory advanced mycosis fungoides or sézary syndrome

Conditions: Lymphoma

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.

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.

Eligibility criteria:
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

Keywords: 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