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

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.

Conditions

• KSHV Inflammatory Cytokine Syndrome (KICS)
• KSHV
• HHV-8

Interventions

DRUG

Zidovudine

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.

DRUG

Liposomal Doxorubicin

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

DRUG

Valganiclovir

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.

DRUG

Rituximab

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.

OTHER

Standard Therapies

Standard of Care drugs

OTHER

Cohort 1

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Robert Yarchoan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-08

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations