A Phase I Open-Label Single-Dose Study of Humanized MiK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R/IL-15R{beta} Subunit (CD122) in T-Cell Large Granular Lymphocytic Leukemia
Protocol # 04-C-0089
- 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?
This the first clinical trial studying the activity and effects of a humanized monoclonal antibody (Mik-beta-1) targeting the beta chain shared by the interleukin-2 (IL-2) and interleukin-15 (IL-15) receptors on the surface of lymphocytes. The binding of IL-15 to its receptor is thought to stimulate the growth of T-cell large granular lymphocyte leukemia (T-LGL). Blocking of IL-15 from binding to its receptor may slow or stop the growth of T-LGL cells, decrease the number of leukemic cells in the circulation and improve T-LGL-associated hemocytopenias.
Who is eligible for this trial? (PDQ)
- Histologically or cytologically confirmed T-cell large granular lymphocytic (T-LGL) leukemia
- T-LGL-associated hemocytopenia
- No symptomatic CNS involvement by leukemia
- ≥ 4 weeks since prior interferon, chemotherapy, and/or cyclosporine
- No NY Heart Association class III or IV CHF
What types of drugs or therapies are being used?
Humanized monoclonal antibody directed against the shared interleukin-2 (IL-2) and interleukin-15 (IL-15) receptor beta-chain (anti-CD122).
What is the treatment plan? (PDQ)
- Patients will receive monoclonal antibody Mik-beta-1 intravenously over 90 minutes on Day 1 followed by monitoring for side effects, blood levels of the antibody, receptor saturation with the antibody, serum chemistries and blood counts for 6 weeks
- Cohorts of 3-6 patients will receive escalating doses of monoclonal antibody Mik-beta-1 until the maximum tolerated dose (MTD) is determined
- Patients will be followed weekly for 6 weeks and then every 3 months for 9 months
What is the frequency and duration of the visits?
An inpatient stay of 3-4 days will be required with the initial administration of the study drug and patients will be required to remain within reasonable traveling distance of the NIH Clinical Center for a total of 7-8 days after treatment to be able to obtain drug blood levels; subsequent follow-up visits at the NIH Clinical Center will require 1 day.
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 C. Morris received his B.A. with honors in Biology from Queens College (CUNY) in Flushing, N.Y. in 1978, and his M.D. degree in 1982 from the Upstate Medical Center College of Medicine (SUNY) in Syracuse, N.Y. He completed a residency in Internal Medicine and a clinical fellowship in Medical Oncology at the Mount Sinai Hospital in New York City. He served as Chief Medical Resident and subsequently as Assistant Professor of Medicine and Neoplastic Diseases at Mount Sinai. Dr. Morris did a post-doctoral fellowship in the Clinical Gene Therapy Branch of the National Human Genome Research Institute from 1995 to 1999. In 1999, he joined the NCI's Metabolism Branch's Clinical Program where he has focused on tumor vaccines and monoclonal antibody therapy of cancer. Dr. Morris is board-certified in Internal Medicine and Medical Oncology.
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 C. Morris, M.D.
Principal Investigator
Phone: 301-402-2912
jmorris@mail.nih.gov
Thomas Waldmann, M.D.
Protocol Chair
Phone: 301-496-6656
tawald@helix.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?
Back to Top
