Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: Alefacept
Intervention description: Dose escalation theme. 0.075mg/kg by IV Weekly x 8 to 0.30mg/kg IV Weekly x 8
Intervention MeSH terms: Alefacept
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent cutaneous T-cell non-Hodgkin lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma; adult nasal type extranodal NK/T-cell lymphoma; recurrent mycosis fungoides/Sezary syndrome

Summary:

      RATIONALE: Combinations of biological substances in alefacept may be able to carry
      cancer-killing substances directly to cancer cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of alefacept in
      treating patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell
      non-Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed cutaneous T-cell lymphoma (CTCL) or peripheral T-cell
             non-Hodgkin's lymphoma

               -  Diagnostic biopsies must have been obtained within the past 6 months

          -  Relapsed or refractory disease

               -  Patients with CTCL must have failed ≥ 2 skin-directed therapies

                    -  No limit on the number of prior therapies

          -  Measurable disease, defined as at least 1 bidimensionally measurable lesion > 2 cm by
             CT scan, MRI, physical exam, or photograph with appended ruler

               -  At least 2 bidimensionally measurable target lesions required for patients with
                  skin lesions only

          -  No CNS lymphoma

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Absolute neutrophil count ≥ 1,000/mm^3

          -  Platelet count ≥ 75,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  Total bilirubin ≤ 2 times upper limit of normal (ULN) OR direct bilirubin ≤ 1.5 times
             ULN

          -  AST ≤ 3 times ULN (≤ 5 times ULN if liver involvement)

          -  Creatinine ≤ 2 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Willing to provide all research blood samples as required by the protocol

          -  Willing to undergo repeat biopsy of either an accessible skin lesion or lymph node, if
             there are no circulating sezary cells, for the purpose of research studies (patients
             without easily accessible lesions are not required to have a repeat biopsy solely for
             research purposes but must be willing to provide a portion of the on-study biopsy or a
             previous lymphoma biopsy, if available)

          -  No known congenital or acquired immunodeficiency syndromes, including HIV

          -  No known active viral hepatitis or tuberculosis infection

          -  No uncontrolled infection

          -  No other uncontrolled serious medical condition unrelated to lymphoma (e.g., cardiac
             arrhythmia or diabetes)

          -  No other active malignancies

          -  No history of serious allergic reaction to citrate or glycine

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 3 weeks since prior cytotoxic chemotherapy

          -  More than 3 weeks since prior denileukin diftitox

          -  More than 3 weeks since prior radiotherapy (less than 3 weeks if the acute side
             effects of this therapy are resolved)

          -  More than 2 weeks since prior oral corticosteroids (unless being used to treat adrenal
             insufficiency)

          -  More than 2 weeks since prior phototherapy, including ultraviolet B and psoralen with
             ultraviolet A

          -  More than 1 week since prior biologic therapy

          -  No concurrent chemotherapy, other immunotherapy, or radiotherapy

          -  No other concurrent investigational agents