Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Northwestern University
With
Millennium Pharmaceuticals, Inc.
Genzyme, a Sanofi Company
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
