Protocol Details
Natural History Study of KSHV-Associated Multicentric Castleman's Disease
This study is currently recruiting participants.
Summary
Number |
000337-C |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A |
Referral Letter Required |
No |
Population Exclusion(s) |
Fetuses;
Pregnant Women;
Children |
Keywords |
Kaposi s sarcoma;
HIV;
primary effusion lymphoma;
interlerleukin-6;
Natural History |
Recruitment Keyword(s) |
None |
Condition(s) |
Multicentric Castleman s disease |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Cancer Institute |
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.
Eligibility
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
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT04968288