Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2019-07-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alefacept

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