Phase I/II Study of the Efficacy and Toxicity of Humanized Anti-Tac (Zenapax®) in the Therapy of Tac-Expressing Adult T-Cell Leukemia
Protocol # 00-C-0030
- 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?
HTLV-1-associated adult T-cell leukemia/lymphoma (ATL) is an aggressive lymphoproliferative disorder characterized by rapidly rising white blood cell counts, hypercalcemia, skin involvement, hepatosplenomegaly and lytic bone lesions. It is often poorly responsive to standard chemotherapy and patient survival is limited. This clinical trial is studying daclizumab (Zenapax®), a humanized monoclonal antibody targeting the interleukin-2 (IL-2) receptor (CD25) that is over expressed on the surface of ATL cells. Daclizumab blocks the binding of IL-2 to the receptor. This trial is focusing on patients with smoldering and chronic stage ATL where the interaction of IL-2 with its receptor (CD25) is believed to play a role in stimulating tumor cell proliferation and progression of ATL. Phase I demonstrated that high saturating doses of daclizumab could be safely administered to ATL patients. Binding of the CD25 receptor by daclizumab and blocking of IL-2 binding may slow the progression of ATL.
Who is eligible for this trial? (PDQ)
- Histologically proven Tac-expressing adult T-cell leukemia/lymphoma (ATL)
- Smoldering or chronic stage ATL
- Measurable disease (defined as > 5% abnormal peripheral blood mononuclear cell)
- Normal lymphocyte count (< 4,000/mm3)
- No hypercalcemia, lymphadenopathy, malignant pleural effusion or ascites
- No symptomatic CNS disease due to ATL
- > 3 weeks since prior chemotherapy for ATL and no concurrent anticancer agents
- Age ≥ 10
What types of drugs or therapies are being used?
Humanized anti-CD25 monoclonal antibody (daclizumab, Zenapax®, anti-Tac).
What is the treatment plan? (PDQ)
Phase I (closed to accrual 6/11/2001)
Phase II (open to smoldering and chronic stage ATL only)
- Patients will receive daclizumab 8 mg/kg intravenously every 3 weeks
- Patients who achieve and maintain a complete or partial response to treatment after 6 courses in the absence of dose-limiting toxicity may continue to receive daclizumab for a total of 24 months
What is the frequency and duration of the visits?
Treatment is usually administered in the outpatient setting. The initial treatment stay at the NIH Clinical Center will be 3-4 days; subsequent visits to the NIH Clinical Center will be 1 day. Patients will be required to return to the NIH Clinical Center every 3 weeks for evaluation and treatment for the first six cycles of treatment. Patients responding after six treatments may be able to arrange to have their treatments given to them by a local physician and will be followed at the NIH Clinical Center every 9 weeks while on maintenance therapy.
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?
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