NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

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.

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Eligibility

INCLUSION CRITERIA:

-Biopsy proven KSHV-associated MCD, confirmed in the Laboratory of Pathology, 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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Ramya M. Ramaswami, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 6N110
10 CENTER DR
BETHESDA MD 20892
(240) 506-1088
ramya.ramaswami@nih.gov

Irene Ekwede, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4N216
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6126
irene.ekwede@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04968288

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NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

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.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

-Biopsy proven KSHV-associated MCD, confirmed in the Laboratory of Pathology, 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


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Ramya M. Ramaswami, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 6N110
10 CENTER DR
BETHESDA MD 20892
(240) 506-1088
ramya.ramaswami@nih.gov

Irene Ekwede, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4N216
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6126
irene.ekwede@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04968288

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