Study on Virotherapy and Natural History of KSHV-Associated Multicentric Castleman's Disease
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00092222
This study aims to understand a rare disorder called KSHV-associated multicentric Castleman's disease (MCD) and explore potential treatments. The disease is linked to a virus known as KSHV, which can cause certain cancers. Researchers are investigating how this disease develops and looking for ways to treat it effectively.
Patient Parameters
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Program Overview
This study focuses on a rare condition called KSHV-associated multicentric Castleman's disease (MCD), which is linked to a virus called KSHV. This virus can cause several types of cancer, including some forms of MCD. The study aims to understand how KSHV-MCD develops and to find effective treatments, as there is currently no standard therapy that works for all cases. The disease can be very serious, with about half of the patients not surviving beyond two years after diagnosis. Participants in this study will undergo more frequent blood tests and tumor biopsies than usual to help researchers learn more about the disease and its symptoms. The study will also test some experimental treatments, which may have side effects like nausea, vomiting, and low blood counts. Although the study may not directly benefit participants, it could provide valuable information for future treatments.
Description
Multicentric Castleman's disease (MCD) is a rare and serious condition associated with the Kaposi's sarcoma herpesvirus (KSHV). It is more common in people with HIV, but it can also affect those without HIV. The disease has no standard treatment and is often fatal, with a median survival of about two years. This study aims to explore new treatment approaches, including virotherapy, which targets the virus causing the disease. Researchers are testing various treatments, such as high-dose zidovudine and ganciclovir, sometimes combined with other drugs like bortezomib or rituximab. These treatments aim to specifically target and kill the virus-infected cells. Participants will be closely monitored, and the study will help researchers understand the disease better and develop new treatments. The study includes regular PET scans to track disease activity and assess how well the treatments are working. While the study may not provide direct benefits to participants, it could lead to better treatment options in the future.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of KSHV-associated multicentric Castleman's disease (MCD) through a biopsy.
- Willing to provide informed consent to participate in the study.
Exclusion Criteria
- Have any severe health issues unrelated to HIV or MCD that would prevent safe participation in the study.
- Have another cancer that requires treatment, which would interfere with the study treatments or monitoring.
- Pregnant women cannot participate due to potential risks to the fetus from the study treatments.
- Any condition that the researchers believe would make participation unsafe or inappropriate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
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