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

Eastern Cooperative Oncology Group

Status and phase: Terminated; Phase 2

Conditions: Lymphoma

Treatments: Drug: cyclosporine

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00070291

CDR0000331864

E2402 (Other Identifier)

U10CA021115 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Cyclosporine

Experimental group

Description:

High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.

Treatment:

Drug: cyclosporine