Phase II Study of UCN-01 in Relapsed or Refractory Systemic Anaplastic Large Cell and Mature T-Cell Lymphomas
Protocol # 04-C-0173
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the study outline?
- 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?
In this study we are investigating an experimental drug called UCN-01 or 7-hydroxystaurosporine. We know from studies in the laboratory that UCN-01 works in many different ways and it has been shown to inhibit the growth of many different tumor cells. Studies in the laboratory have shown that this drug works particularly well on some tumor cells taken from patients with T-cell lymphomas and tumors that have a particular protein expressed called ALK.
Who is eligible for this trial? (PDQ)
- Histologically confirmed diagnosis of 1 of the following:
- Anaplastic large cell lymphoma, systemic disease T or null phenotype
- Mature T-cell lymphoma of 1 of the following subtypes:
- Peripheral T-cell lymphoma, unspecified
- Adult T-cell lymphoma
- Extranodal NK/T-cell lymphoma (nasal type)
- Enteropathy-type T-cell lymphoma
- Hepatosplenic T-cell lymphoma
- Subcutaneous panniculitis-like T-cell lymphoma
- Angioimmunoblastic T-cell lymphoma
- Relapsed or refractory disease
- Measurable or evaluable disease
- Must have received at least 1 prior regimen for lymphoma
- Requires systemic therapy for at least 1 of the following conditions:
- Symptomatic disease
- High risk for organ dysfunction
- Active organ dysfunction
- Ineligible for, or refused potentially curative therapy (i.e., transplantation)
- ECOG performance status < 2
- Adequate hematologic, renal, and hepatic function
- HIV negative
- No pregnant or nursing females; all subjects must be willing to use contraception and continue for at least 8 weeks after last treatment
- At least 3 weeks since treatment with systemic cytotoxic chemotherapy
- At least 6 weeks since treatment with nitrosureas or mitomycin C
- No active CNS lymphoma
- Age 9 and over
- No history of diabetes mellitus requiring insulin treatment
- No symptomatic pulmonary or cardiac disease
- No concurrent use of other investigational agents
- Recovery from toxic effects of prior therapies
What types of drugs or therapies are being used?
We know from studies in the laboratory that UCN-01 works in many different ways and it has been shown to inhibit the growth of many different tumor cells.
What is the study outline? (PDQ)
- Patients receive UCN-01 IV over 72 hours on days 1—3 of course 1 and over 36 hours on days 1—2 of all subsequent courses
- Courses repeat every 28 days
- In the absence of disease progression or unacceptable toxicity, patients may continue to receive UCN-01 for 1 year beyond achieving maximum response or stable disease
- Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter
What is the frequency and duration of the visits?
The UCN-01 will be given in courses. Each course is 21 days or 3 weeks apart and is called a cycle. UCN-01 will be continuously administered by vein through a catheter for 3 days (72 hours) on the first cycle, and for 1½ days (36 hours) on the remainder of the cycles. The patient will be admitted to the hospital during the UCN-01 administration.
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. Wyndham H. Wilson received his B.A. and M.S. degrees in biology from Stanford University in 1975. In 1981, he received his Ph.D. in neurobiology and M.D. from Stanford, completing his residency training in internal medicine at Stanford in 1984. From 1984 to 1987, he was a clinical associate in the Medicine Branch, NCI, where he completed a fellowship in medical oncology. Dr. Wilson was special assistant to the director, Division of Cancer Treatment, NCI, from 1988 to 1995. In 1995, he joined the former Medicine Branch as a senior oncologist.
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?
Wyndham H. Wilson, M.D., Ph.D.
Principal Investigator
Phone: 301-435-2415
wilsonw@mail.nih.gov
Alan Wayne, M.D.
Protocol Chair
Phone: 301-496-4256
waynea@mail.nih.gov
Referrals:
Peggy Shovlin, R.N., B.S.N.
Research Nurse
Phone: 301-594-6597
mshovlin@mail.nih.gov
Where can additional information be found?
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