Phase II Study of the Efficacy and Toxicity of CAMPATH-1H in the Therapy of Adult T-Cell Leukemia
Protocol # 03-C-0194
- 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. ATL is often poorly responsive to standard chemotherapy and patient survival is limited. This clinical trial is studying the activity of alemtuzumab (CAMPATH®), a humanized monoclonal antibody targeting the CD52 antigen that is over expressed on the surface of ATL cells. Alemtuzumab has shown significant antitumor effects in a number of other lymphoid malignancies and preclinical studies in the Metabolism Branch have shown that it is highly active against this leukemia/lymphoma in a human ATL xenograft mouse model. This study will evaluate the antitumor activity and side effects of alemtuzumab in patients with HTLV-1-associated ATL.
Who is eligible for this trial? (PDQ)
- Histologically confirmed adult T-cell leukemia (ATL)/lymphoma
- HTLV-1-positive
- Acute, lymphomatous or chronic stage disease
- Measurable disease (defined as ≥ 10% abnormal peripheral blood mononuclear cells or measurable tumor)
- No symptomatic leukemic meningitis
- No prior alemtuzumab therapy
- > 3 weeks since prior chemotherapy for ATL and no concurrent anticancer chemotherapy
What types of drugs or therapies are being used?
Alemtuzumab (CAMPATH®), a humanized monoclonal antibody directed at the CD52 antigen over expressed on adult T-cell leukemia/lymphoma cells.
What is the treatment plan? (PDQ)
- Patients will receive escalating doses of alemtuzumab intravenously (IV) once daily until the target dose is reached and tolerated
- Patients will then receive the target dose of alemtuzumab IV over 2 hours 3 times weekly for up to a total of 12 weeks in the absence of disease progression or unacceptable toxicity
- Patients will be followed monthly until the CD4 count has recovered and then every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and annually thereafter
What is the frequency and duration of the visits?
Patients are required to receive treatment at the NIH Clinical Center for minimum of 5 weeks and a maximum of 12 weeks. Induction therapy and the first week of maintenance treatment require admission to the inpatient unit. Since treatment is administered 3 times per week, patients must remain within reasonable traveling distance of the NIH Clinical Center or remain as an inpatient while on treatment. Outpatient visits 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
John Janik, M.D.
Protocol Chair
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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