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

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclosporine; Cyclosporins

Criteria

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.