Official Title: “Microarray Analysis of the Effect of Cyclosporin Therapy on Gene Expression in Large Granular Lymphocyte (LGL) Leukemia”

RATIONALE: Drugs used in chemotherapy, such as cyclosporine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Collecting samples of blood from patients with cancer who have had cyclosporine to study in the laboratory may help doctors learn more about changes that may occur in DNA and predict how well patients will respond to treatment with cyclosporine.

PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with T-cell large granular lymphocyte leukemia.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: December 2010

OBJECTIVES:

Primary - Identify changes in gene expression patterns induced by cyclosporine therapy in patients with T-cell large granular lymphocyte leukemia.

Secondary - Identify differences between responding and nonresponding patients.

OUTLINE: Patients receive oral cyclosporine twice daily. Treatment continues for 3 months followed by a taper in the absence of disease progression or unacceptable toxicity.

Patients undergo apheresis for collection of circulating blood cells at baseline, once steady-state levels of cyclosporine are achieved, and at 6 and 12 weeks after beginning therapy.

Gene expression analysis is performed on pre- and post-treatment samples at baseline and 12 weeks, respectively.

After completion of study treatment, patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.

Intervention(s) in this Clinical Trial

• Drug: cyclosporine
• Procedure: gene expression analysis
• Procedure: gene expression profiling
• Procedure: laboratory biomarker analysis

Primary Measures

• Changes in gene expression patterns
  • Safety Issue?: No

Secondary Measures

• Differences of gene expression between responding and nonresponding patients at 12 weeks
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed T-cell large granular lymphocyte (LGL) leukemia
• Must have hemocytopenia, including ≥ 1 of the following:
• Granulocyte count < 1,200/mm³
• Platelet count < 100,000/mm³
• Hemoglobin < 10 g/dL
• Transfusion or colony-stimulating factors required to maintain hematopoietic counts
• Measurable or evaluable disease
• Must not have failed prior therapy with cyclosporine for LGL leukemia

PATIENT CHARACTERISTICS:

• Karnofsky performance status 80-100%
• Life expectancy > 3 months
• Creatinine < 2.0 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• No uncontrolled hypertension
• No HIV positivity
• No underlying immunodeficiency
• No hepatitis C antibody positivity or hepatitis B surface antigen positivity
• No serious intercurrent illnesses or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• At least 3 weeks since prior cytotoxic chemotherapy
• Concurrent stable-dose corticosteroids allowed
• No other concurrent chemotherapy or investigational anticancer drugs
• No concurrent monoclonal antibodies, gammaglobulin, or drugs that affect lymphocytes

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Cancer Institute (NCI)

Overall Clinical Trial Officials and Contacts

John E. Janik, MD Principal Investigator NCI - Metabolism Branch;MET  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00363779

Study ID Number: CDR0000490052

ClinicalTrials.gov Identifier: NCT00363779

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database

Web site for additional information