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Natural History of KSHV-Associated Multicentric Castleman s Disease

Natural History Study of KSHV-Associated Multicentric Castleman's Disease

Who can join

Ages 18 and older · All sexes

* INCLUSION CRITERIA:
* Biopsy proven KSHV-associated MCD, confirmed in the Laboratory of Pathology (LP), CCR
* Age \>=18 years.
* ECOG performance status \<=4 (Karnofsky \>=20%).
* Ability of subject to understand and the willingness to sign a written informed consent document.
* Participants may be co-enrolled in other protocols, including investigational studies to treat KSHV-associated malignancies.

EXCLUSION CRITERIA:

* Any condition or set of circumstances that in the opinion of the investigators would make participation in this study unsafe or otherwise inappropriate for a given individual.
* Pregnancy

About the study

Background:

Kaposi s sarcoma herpes virus (KSHV) causes several kinds of cancer, Kaposi sarcoma (KS), a form of Multicentric Castleman s Disease (MCD) and a type of lymphoma known as Primary Effusion Lymphoma (PEL). These cancers can occur alone or at the same time in the same patient. MCD can cause a lot of symptoms and problems with various organs in the body, making patients feel quite unwell. If unrecognized, the disease can be fatal. Medications such as rituximab alone or in combination with chemotherapy may help treat MCD but there is little known about the long term effects and the natural course of MCD.

Objective:

To better understand the biology of KSHV-MCD to help identify how this disease causes illness and how cancer treatments known to be effective in MCD may help patients with this condition. This study also aims to help identify ways to treat the disease by providing other standard cancer treatments that would be useful to use to treat MCD based on what we know about this condition.

Eligibility:

People 18 years of age and older with KSHV-MCD.

Design:

Participants will be screened with:

Medical history

Physical exam

CT scan

Blood and heart tests

Participants will have an initial evaluation. This will include:

Review of participants symptoms and ability to perform their normal activities

Blood and urine tests

Imaging studies such as CT and PET scans. Participants may have a contrast agent injected into their arm.

Photographs to document skin lesions

Optional skin biopsy. For this, a small piece of the skin will be removed.

Optional lymph node needle biopsy

Optional samples of the fluid in the space around the lungs, intestines, or heart

Optional sample of the liquid that surrounds the brain and spinal cord

Saliva samples

DEXA scan to examine the bones

Questionnaires

Optional limb measurements or cognitive tests

Physicians will give participants recommendations about treatment.

After their initial evaluation and any treatment, participants will have additional visits. These will occur every 3 months for the first year, then every 6 months for the second year, and then once a year for up to 1 year.

Sponsor: National Cancer Institute (NCI) · Participants: 195 · Started: Nov 17, 2021

Contact the study team

• Irene B Ekwede, R.N. · Phone: (240) 760-6126
• Ramya M Ramaswami, M.D. · Phone: (240) 506-1088

Official record on ClinicalTrials.gov — NCT04968288

Locations in the U.S.

Conditions

• Primary Effusion Lymphoma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.