A Phase II Clinical Trial of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Cutaneous T-Cell Lymphomas
Protocol # 04-C-0142
- 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?
Patients with cutaneous T-cell lymphoma, particularly in advanced stages, need additional options for therapy. The malignant cells often display the marker CD25, which makes them potential targets for the recombinant immunotoxin LMB-2.
Who is eligible for this trial? (PDQ)
- Histologically confirmed cutaneous T-cell lymphoma (CTCL)
- Stage IB-IV disease
- CD25-positive disease meeting at least 1 of the following criteria:
- At least 20% expression of CD25 on the lymphocytes in the skin at a site of a patch, plaque, or tumor
- At least 20% of the peripheral blood Sézary cells must be CD25-positive
- Disease progression after at least 2 prior systemic or topical therapies
- Measurable disease
What types of drugs or therapies are being used?
Recombinant immunotoxin LMB-2, a protein composed of a binding antibody part, and a toxin. After binding to and being internalized by target cells, the toxin kills the cell with extreme potency. LMB-2 therefore kills leukemia cells directly without needing help from the immune system, which is often damaged due to leukemia and prior treatment.
What is the treatment plan? (PDQ)
- Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5
- Treatment repeats every 28 days for up to 6 courses in the absence of disease progression, unacceptable toxicity, or neutralizing antibodies
- Patients receive up to 2 additional courses after achieving a complete remission
- Patients are followed after completing protocol treatment
What is the frequency and duration of the visits?
Blood samples are sent ahead of time and tested free of charge at NIH to determine eligibility. During the first visit, patients typically spend 3 days taking baseline tests. When treatment begins, a cycle includes treatment by 30-minute infusion every other day for 3 doses, and patients usually return home a week after beginning. Patients who have not made antibodies against LMB-2 and whose disease has not worsened on treatment may be eligible for additional cycles at approximate monthly intervals. LMB-2 may be given as an inpatient or outpatient.
What are the costs?
There is no charge for medical care received at the NIH Clinical Center. Study participants will be responsible for travel costs for their initial screening visits. Once participants are enrolled in this trial, NCI will pay for the transportation costs for all subsequent trial-related visits for participants who do not live in the local area. In addition, these participants will receive a small per diem for food and lodging expenses if they are being treated as outpatients.
Who is the Principal Investigator?
Dr. Robert J. Kreitman received his M.D. from Ohio State University in 1985 and obtained his internal medicine residency training at Duke University from 1985 to 1988. He received his medical oncology fellowship training at the NIH from 1988 to 1991, has been working in the immunotoxin field since 1989, and has been directing clinical trials with immunotoxins since 1996. He won Federal Technology Transfer awards in 1994 and 1999-2005. He has won several awards from the U.S. Public Health Service, including the Commendation Medal 1999 and the Outstanding Service Medal in 2002.
Where is this trial taking place?
Warren Grant Magnuson Clinical Center
National Institutes of Health
NCI Laboratory of Molecular Biology
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
Robert J. Kreitman, M.D.
Principal Investigator
Phone: 301-496-6947
kreitmar@mail.nih.gov
Referrals:
Linda Ellison, R.N.
Research Nurse
Phone: 301-496-9458
Fax: 240-220-7677
ellisonl@mail.nih.gov
Rita Mincemoyer, R.N.
Research Nurse
Phone: 301-594-1778
Fax: 240-220-7677
mincemor@mail.nih.gov
Elizabeth Maestri, R.N.
Research Nurse
Phone: 301-402-5633
Fax: 240-220-7677
maestrie@mail.nih.gov
Where can additional information be found?
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