Microarray Analysis of the Effect of Cyclosporine Therapy on Gene Expression Patterns in Large Granular Lymphocytic Leukemia
Protocol # 06-C-0177
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the study outline?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
Cyclosporin is an accepted form of therapy for patients with LGL leukemia. Responses are observed with improvement in abnormal blood counts in up to 50% of patients without significantly altering the number of malignant T cells. Response typically require several months of treatment before clinical improvement is noted. This study will evaluate the effect of cyclosporin on the microarray profiles of the malignant cells in patients with LGL leukemia. This may allow us to distinguish patients who are going to respond to the treatment at early time points and eliminate the need for long periods of treatment with an ineffective drug. This study may also allow us to identify the targets for cyclosporin's action and evaluate other candidate drugs that affect the target genes as therapeutic agents in LGL leukemia.
Who is eligible for this trial? (PDQ)
- Histologic or cytologic diagnosis of T-cell LGL leukemia
- Measurable or evaluable disease
- 18 years of age and over
- Hemocytopenias such as granulocyte count < 1,200/ul, platelet count < 100,000/ul or hemoglobin < 10 g/dl, or require hematopoietic support (transfusion or colony stimulating factors) to maintain counts at these or higher levels
- Creatinine < 2.0 mg/dl
- Karnofsky performance > 70%
- Life expectancy > 3 months
- No uncontrolled hypertension
- No immunodeficiency; no HIV; no Hepatitis C; no Hepatitis B
- No serious intercurrent illnesses; no concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious or metabolic disease
- No other condition that would preclude study participation
- Patients who received cyclosporine for LGL leukemia previously and failed to respond will be excluded from study participation
What types of drugs or therapies are being used?
This is an oral agent. It has suppressive effects on the immune system.
What is the study outline? (PDQ)
- Patients receive cyclosporine at a dose of 5-10mg/kg/day in divided doses, with doses adjusted to maintain a therapeutic serum level between 200-400ng/ml; therapeutic levels will be maintained for 3 months
- Tumor response will be evaluated after 3 months' therapy, the dose of CsA may then be tapered to that required to sustain a response or discontinued if no evidence of response, or after relapse
- Blood sampling or lymphapheresis for collection of circulating malignant cells will be performed at a number of different time points
- Gene expression profiling will be carried out on Affymetrix microarrays to compare pretreatment and post-treatment samples
What is the frequency and duration of the visits?
Treatment is given as an outpatient. Patients will be seen in weeks one and two and then at four week intervals for twelve weeks. During the first two weeks cyclosporine levels are measured and adjusted to assure appropriate drug levels.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. John E. Janik received his M.D. from the Ohio State University College of Medicine in 1977 and completed clinical training in internal medicine at Baylor College of Medicine Affiliated Hospitals and hematology/oncology training at Case Western Reserve University. He joined the NCI in 1989 at the Biological Response Modifiers Program in Frederick, Md. In 1999 he was appointed the Co-Director, Clinical Trials Team in the Metabolism Branch.
Where is this trial taking place?
NIH Clinical Center
National Institutes of Health
NCI Metabolism Branch
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
John E. Janik, M.D.
Principal Investigator
Phone: 301-402-2913
janikj@mail.nih.gov
Referrals:
Debbie Draper, R.N., B.S.N.
Research Nurse
Phone: 301-435-8525
draperde@mail.nih.gov
Suzanne Fioravanti, R.N., B.S.N., O.C.N.
Research Nurse
Phone: 301-594-6544
Fax: 301-480-7281
fioravas@mail.nih.gov
Where can additional information be found?
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