Experimental Therapies for KICS
What You Need to Know Before You Apply
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might depend on the specific treatments you receive during the study, so it's best to discuss this with the study researchers.
Is the treatment generally safe for humans?
Pegylated liposomal doxorubicin (Doxil, Caelyx) has been shown to have a favorable safety profile compared to conventional doxorubicin, with reduced heart-related side effects and mild skin and mouth-related toxicities. It has been used safely in various cancers, including breast and ovarian cancer, with ongoing studies to further understand its safety in combination treatments.12345
How does the drug for KICS differ from other treatments?
The drug for KICS, which involves liposomal doxorubicin, is unique because it uses a special coating to help the medicine stay in the bloodstream longer and target tumor sites more effectively, reducing side effects compared to traditional chemotherapy. This approach has been shown to be effective in treating similar conditions like Kaposi's sarcoma with fewer side effects.16789
What data supports the effectiveness of the drug Liposomal Doxorubicin for treating KICS?
Liposomal Doxorubicin has been shown to be effective in treating Kaposi's sarcoma, particularly in patients with HIV, with studies reporting partial or complete resolution of symptoms. This suggests potential effectiveness for similar conditions like KICS, as both involve immune system complications.167810
Who Is on the Research Team?
Robert Yarchoan, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults with Kaposi sarcoma herpes virus and symptoms like fever, weight loss, or fluid accumulation. They must have evidence of the virus in blood or tissues and may also have related cancers. Participants need to use contraception and can't be pregnant. Those with severe unrelated health issues are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Natural History Observation
Participants are observed for the natural history of KSHV inflammatory cytokine syndrome (KICS) with regular study visits, medical history collection, physical exams, and sample collection.
Treatment (if required)
Participants with KICS requiring treatment may receive experimental treatments including antiviral and chemotherapy drugs.
Follow-up
Participants are monitored for safety and effectiveness after treatment or observation.
What Are the Treatments Tested in This Trial?
Interventions
- Liposomal Doxorubicin
- Rituximab
- Valganiclovir
- Zidovudine
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor