• Toxicity during treatment [ Designated as safety issue: Yes ]
  
• Maximum tolerated dose during treatment [ Designated as safety issue: Yes ]
  

• Anti-tumor activity at the end of treatment [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the toxicity of alemtuzumab and etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH) in patients with chemotherapy-naïve CD52-expressing aggressive T- or NK-cell lymphoma.
• Determine the maximum tolerated dose of alemtuzumab when administered with EPOCH chemotherapy in these patients.

Secondary

• Determine, preliminarily, the antitumor activity of this regimen in these patients.

OUTLINE: This is a pilot, dose-escalation study of alemtuzumab.

Patients receive alemtuzumab IV over 12 hours on day 1 and EPOCH chemotherapy comprising etoposide IV, doxorubicin IV, and vincristine IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 15 minutes on day 5; and oral prednisone twice daily on days 0-5. Patients also receive filgrastim subcutaneously on day 6. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of alemtuzumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued to this study within 2.5 years.

DISEASE CHARACTERISTICS:

• Diagnosis of aggressive T- or NK-cell lymphoma, including, but not limited to any of the following:

  • Peripheral T-cell lymphoma not otherwise specified
  • Gamma-delta hepatosplenic T-cell lymphoma
  • Subcutaneous panniculitis-like T-cell lymphoma

• CD52-positive disease by pathology or flow cytometry

  • T- and NK-cell malignancy without accessible tissue for flow cytometry analysis allowed
• Chemotherapy-naïve disease
• No anaplastic large cell lymphoma (ALCL) except alk-negative ALCL
• No T-cell precursor disease

PATIENT CHARACTERISTICS:

Age

• 17 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,000/mm^3*
• Platelet count at least 75,000/mm^3* NOTE: *Unless due to organ involvement by tumor

Hepatic

• Bilirubin less than 2.0 mg/dL (unless due to Gilbert's syndrome)
• AST and ALT no greater than 3 times upper limit of normal (ULN) (6 times ULN for patients on hyperalimentation)

Renal

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular

• No active symptomatic ischemic heart disease within the past year
• No myocardial infarction within the past year
• No congestive heart failure within the past year

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No other concurrent medical condition or infection that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior biologic therapy allowed
• No other concurrent biologic therapy

Chemotherapy

• See Disease Characteristics
• No other concurrent chemotherapy

Endocrine therapy

• Prior steroids allowed
• No other concurrent endocrine therapy

Radiotherapy

• No prior or concurrent radiotherapy

Surgery

• Not specified