Targeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease Activity
Protocol # 04-C-0275
- 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?
This trial is important because KSHV-associated multicentric Castleman's disease is a poorly understood condition, and there is no standard medical treatment for the disease. This trial is designed to gather information about the disease and to develop new treatment strategies for the disease. The interventions being studied in this trial may have application to other rare diseases if they appear to be effective in this trial.
Who is eligible for this trial? (PDQ)
- Histologically confirmed Kaposi's sarcoma-associated herpesvirus-associated multicentric Castleman's disease
- Aged 12 years or older
- No grade IV toxicity unrelated to HIV, its treatment, or multicentric Castleman's disease that would preclude study therapy
- No other malignancy requiring concurrent treatment that would preclude study therapy or monitoring
- No other condition or circumstance that would preclude study participation
What types of drugs or therapies are being used?
Chemotherapeutic agents: zidovudine, valganciclovir, bortezomib, and EPOCH-R (comprising etoposide, doxorubicin, vincristine, prednisone, cyclophosphamide, and rituximab)
What is the study outline? (PDQ)
Patients are assigned to one of six treatment groups based on disease status.
Group I (observation only)
- Patients with asymptomatic disease undergo observation only, or observation in conjunction with highly active antiretroviral therapy (HAART), where appropriate
Group II (high-dose zidovudine [HDAZT] and valganciclovir [VGCV])
- Patients with symptomatic disease that is not life-threatening receive oral HDAZT four times daily and oral VGCV twice daily on Days 1–21; courses repeat every 21 days
Group III (bortezomib, HDAZT, and VGCV)
- Patients with continued symptomatic disease who are not responding to group II therapy receive bortezomib IV over 3–5 seconds on Days 1, 4, 8, and 11 and HDAZT and VGCV as in group II on Days 1–21
- Courses repeat every 21 days
Group IV (EPOCH-R)
- Patients with life-threatening disease will receive EPOCH-R therapy comprising a 5-day course of rituximab, etoposide, doxorubicin, vincristine, cyclophosphamide, and prednisone
- Treatment repeats every 21 days for up to 6 courses
Group V
- Patients may also receive rituximab IV and doxorubicin hydrochloride liposome IV for 3 to 6 courses followed by interferon alpha maintenance for 6 to 12 months
Group VI
- Patients may also receive oral sirolimus daily with cycle length every 21 days
What is the frequency and duration of the visits?
The frequency and duration of the visits are dependent on the status of the individual. For those without symptoms or problems related to the multicentric Castleman's disease, visits are generally for a single outpatient visit once every 3 months. For persons who are ill, visits may be more frequent as needed, and my include hospitalization if necessary.
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. Robert Yarchoan received his B.A. from Amherst College with a major in biophysics and his M.D. from the University of Pennsylvania. He trained in internal medicine at the University of Minnesota and immunology in the Metabolism Branch, NCI. He then joined the laboratory of Dr. Samuel Broder, where he played a major role in the development of the first effective therapies for HIV infection, including zidovudine (AZT), didanosine (ddI), and zalcitabine (ddC). In particular, he led the first clinical trials of these drugs, was a co-inventor of didanosine and zalcitabine as AIDS therapies, and led initial studies of combination anti-HIV therapy. He was section chief in the Medicine Branch from 1991 to 1996 and was named chief of the newly formed HIV and AIDS Malignancy Branch in 1996. Since that time, he has focused much of his research on AIDS-related malignancies. Among other honors, he has been awarded the Assistant Secretary for Health Award and the U.S. Public Health Service Outstanding Service Medal, has been inducted as a Fellow of the American Association for the Advancement of Science, and is a member of the American Society for Clinical Investigation.
Where is this trial taking place?
NIH Clinical Center
National Institutes of Health
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
Robert Yarchoan, M.D.
Principal Investigator
Phone: 301-496-8959
yarchoan@helix.nih.gov
Thomas Uldrick, M.D.
Lead Associate Investigator
Phone: 301-496-8959
uldrickts@mail.nih.gov
Referrals:
Karen Aleman, R.N., B.S.N.
Research Nurse
Phone: 301-496-8959
1-800-243-2732 ext. 4 (Toll Free)
Fax: 301-402-7552
alemank@mail.nih.gov
Kathleen Wyvill, R.N.
Research Nurse
Phone: 301-496-8959
1-800-243-2732 ext. 4 (Toll Free)
Fax: 301-402-7552
wyvillk@mail.nih.gov
Where can additional information be found?
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