Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma

A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma

RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.

PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.

OBJECTIVES:

Primary

• Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.

Secondary

• Determine the disease-free, progression-free, and overall survival of patients treated with this drug.
• Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6. Patients experiencing disease progression during weeks 7-36, receive an additional 36 weeks of therapy.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 2.5 years.

Inclusion Criteria:

• Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination.
• At least one objective measurable or evaluable disease parameter.
• Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate renal function as indicated by creatinine <= 1.5 the upper limit of normal (ULN).
• Adequate liver function as indicated by alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 2x the upper limit of normal.
• Total bilirubin <= 2x the upper limit of normal.
• Age 18 or older.

Exclusion Criteria:

• Prior cyclosporine or Tacrolimus (FK506).
• Prior allogeneic transplant.
• Evidence of active infection.
• Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities.
• Evidence of active neurological impairment.
• Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL (polyoxyethylated oil).
• History of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin).
• pregnant or breastfeeding women.
• Human immunodeficiency virus (HIV) positive.