RecruitingPhase 2NCT01419561

Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)


Sponsor

National Cancer Institute (NCI)

Enrollment

140 participants

Start Date

Sep 8, 2011

Study Type

INTERVENTIONAL

Conditions

Summary

Background: \- KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by Kaposi sarcoma-associated herpesvirus (KSHV). This virus can cause cancer. People with KICS can have severe symptoms. They include fever, weight loss, and fluid in the legs or abdomen. People with KICS may also be at risk of getting other cancers associated with KSHV. These cancers include Kaposi sarcoma and lymphoma. Because KICS is a newly identified disease, more information is needed on how the disease works and what can be done to treat it. Objectives: \- To collect genetic and medical information from people with KSHV inflammatory cytokine syndrome. Eligibility: \- Individuals at least 18 years of age who have Kaposi sarcoma herpes virus and symptoms that resemble those caused by KICS. Design: * Participants will have regular study visits. The schedule will be determined by the study researchers. * Participants will provide a complete medical history and have a full physical exam. Blood and urine samples will be collected as well. * People with KICS that requires treatment may get new experimental treatments. These treatments may include antiviral drugs and chemotherapy drugs, depending on the nature of the disease. * Participants will have imaging studies, such as chest x-rays and computed tomography scans, to study the tumors. * Bone marrow and lymph node biopsies may be done to collect tissue samples for study. * Participants who have Kaposi sarcoma will have photographs taken of their lesions.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is following people who show signs of KICS — a rare and serious condition caused by a virus called KSHV that triggers severe inflammation throughout the body — to better understand how the disease progresses and how to treat it. **You may be eligible if...** - You are 18 years of age or older - You have any HIV status (positive or negative) - You have at least two symptoms or abnormal test results possibly related to KICS, such as fever, chills, fatigue, unexplained weight loss, low sodium levels, or swollen lymph nodes that cannot be explained by another known condition **You may NOT be eligible if...** - You are under 18 years old - Your symptoms are clearly explained by another medical condition - You are unable or unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZidovudine

Zidovudine 600 mg will be administered orally 4 times a day or i.v. at 300 mg every 6 hours for 14 days for cycle 1 and for 7 days (up to additional 7 days if ongoing symptoms) for following cycles.

DRUGLiposomal Doxorubicin

Liposomal doxorubicin (20 mg/m2) will be administered i.v. over 1 hour at day 1 of each cycle

DRUGValganiclovir

Valganciclovir (900mg) will be administered orally twice/day or Ganciclovir (5 mg/kg) will be administered i.v. over 1 hour for 14 days for cycle 1 and for 7 days (up to additional 7 days if ongoing symptoms) for following cycles.

DRUGRituximab

Rituximab (375 mg/m2) will be admnistered i.v. at 50 mg/hr up to 100 mg/hr at day 1 of the first cycle and at 100mg/hr up to 400 mg /hr at day 1 of following cycles.

OTHERStandard Therapies

Standard of Care drugs

OTHERCohort 1

Participants who are infected with KSHV who meet criteria for inflammatory cytokine syndrome (KICS)


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT01419561


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