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

Northwestern University

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Biological: alemtuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00057967

STU00012258 (Other Identifier)

NU 99H8 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 37 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Treatment arm

Experimental group

Description:

alemtuzumab

Treatment:

Biological: alemtuzumab