Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

37

Study ID:

NCT00057967

Recruitment Status:

Completed

Sponsor:

Northwestern University

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There is 1 Location for this study

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Northwestern University, Northwestern Medical Faculty Foundation
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

37

Study ID:

NCT00057967

Recruitment Status:

Completed

Sponsor:


Northwestern University

How clear is this clinincal trial information?

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