Phase II Study of the Efficacy and Toxicity of Ontak® (Denileukin Diftitox) in the Therapy of Adult T-Cell Leukemia
Protocol # 05-C-0185
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the treatment plan?
- 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?
ATL is an aggressive T-cell lymphoproliferative disorder characterized by the presence of malignant CD4/CD25-expressing T cells in the peripheral blood, lymph nodes and other tissues. The various combination chemotherapies so far developed have not increased significantly the survival of patients with ATL. New approaches to treatment are needed and CD25 presents an attractive target for therapy. This fusion molecule delivers diphtheria toxin to the cancer cells because of their expression of CD25 which the interleukin-2 molecule binds to and is internalized.
Who is eligible for this trial? (PDQ)
- Age 18 and over
- Histologically confirmed Tac-expressing adult T-cell leukemia/lymphoma (ATL)
- Stages allowed include chronic, lymphomatous, or acute ATL
- HTLV-1 antibody positive; > 10% of malignant cells must express CD25
- Measurable disease, defined as > 10% abnormal (i.e., TAC homogenous strongly expressing) peripheral blood mononuclear cells
- No smoldering ATL
- Granulocyte count ≥ 1,000/mm3; platelet count ≥ 50,000/mm3; AST and ALT ≤ 2.5 times upper limit of normal (ULN); bilirubin ≤ 3.0 mg/dL; albumin ≥ 2.5 g/dL; creatinine < 2.0 mg/dL
- No symptomatic leukemic meningitis; no prior denileukin diftitox; no concurrent monoclonal antibodies; no concurrent gammaglobulin
- No myocardial infarction within the past 6 months; no severe coronary artery disease
What types of drugs or therapies are being used?
ONTAK® (denileukin diftitox) is a recombinant fusion molecule that deliver a toxic molecule to the cancer cell.
What is the treatment plan? (PDQ)
- Patients receive denileukin diftitox intravenously over 1 hour on Days 1-5
- Treatment repeats every 14 days for up to 24 courses in the absence of disease progression or unacceptable toxicity
- Patients achieving a complete response (CR) receive 2 additional courses of treatment beyond CR
- After completion of therapy, patients are followed at 4 weeks, every 1-3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter
What is the frequency and duration of the visits?
Patients are hospitalized for one treatment every two weeks up to two years.
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:
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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