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

ConditionsKSHV Inflammatory Cytokine Syndrome (KICS)KSHVHHV-8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than or equal to18 Years.

Any HIV status.

Clinical symptoms (each at least grade 1 by CTCAE definitions)

Fever (>38 degrees C), chills or rigors

Disqualifiers

Pregnancy

Any abnormality that would be scored as NCI CTC Grade 4 toxicity that is unrelated to HIV, its treatment, or to KICS that would preclude the use of all of the study treatments or the ability to monitor the natural history of KICS untreated.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zidovudine

    Drug

    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.

  • Liposomal Doxorubicin

    Drug

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

  • Valganiclovir

    Drug

    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.

  • Rituximab

    Drug

    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.

  • Standard Therapies

    Other intervention

    Standard of Care drugs

  • Cohort 1

    Other intervention

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

Treatment groups

140 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: 1No intervention 0 interventions
Group B: 2No intervention 0 interventions
Group C: 3Experimental treatment 2 interventions
Group D: 4Experimental treatment 2 interventions
Group E: 5Other 1 intervention
Group F: 6Other 1 intervention

Trial outcomes

Primary outcomes

1

Natural history of KICS

Description of the natural history of KICS, including the spectrum of clinical, laboratory and radiographic abnormalities seen in affected patients

Time frame
one year

Secondary outcomes

1

Participants with KICS

Evaluate the survival of participants with KICS and of KICS with primary effusion lymphoma (PEL)

Time frame
one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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