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

Trial ID or NCT#

NCT00070291

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

Harlan Pinto
Harlan Pinto
Medical oncologist, Head and neck specialist
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Sandra Horning

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Contact

Cancer Clinical Trials Office
6504987061

View on ClinicalTrials.gov