Tocilizumab for KSHV-Associated Multicentric Castleman Disease
United States8 participantsStarted 2011-09-13
Plain-language summary
Background:
\- Kaposi's sarcoma-associated herpes virus (KSHV)-associated multicentric Castleman disease (KSHV-MCD) is caused by a herpes virus known as KSHV. This disease can also cause several other cancers, including Kaposi sarcoma. People with KSHV-MCD often have symptoms like fever, weight and muscle loss, and fluid in the legs or abdomen. Tocilizumab may be able to block the chemicals in the body that cause KSHV-MCD symptoms. Researchers want to test this drug and other anti-virus drugs to find the best combination of drugs to treat KSHV-MCD.
Objectives:
\- To test the effectiveness of tocilizumab with and without other anti-virus drugs for KSHV-MCD.
Eligibility:
\- People at least 18 years of age who have KSHV-MCD and have certain symptoms and blood abnormalities caused by their KSHV-MCD.
Design:
* Participants will be screened with a medical history and physical exam. They will also have blood tests, and a skin biopsy.
* Participants will have tocilizumab injections every 2 weeks for up to 12 weeks. They will provide daily blood samples for the first 3 days of treatment.
* After the sixth dose, participants will be monitored for 4 weeks to check for possible side effects.
* Those whose KSHV-MCD does not improve or worsens during the study may have tocilizumab combined with two other anti-virus drugs, zidovudine and valganciclovir. These drugs are pills that will be taken four times a day for 5 days out of every 2 weeks.
* Blood, urine, and saliva samples will be collected throughout the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Pathologically confirmed Kaposi sarcoma (KS)-associated herpes virus multi-centric Castleman disease (KSHV-MCD)
* Age greater than or equal to 18
* At least one clinical symptom probably or definitely attributed to KSHV-MCD
* Intermittent or persistent fever for at least 1 week (\>38 degrees C)
* Fatigue (Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater)
* Gastrointestinal symptoms \[includes nausea and anorexia\] (CTCAE Grade 1 or greater)
* Respiratory symptoms \[includes cough and airway hyperreactivity\]
(CTCAE Grade 1 or greater)
* At least one laboratory abnormality probably or definitely attributed to KSHVMCD
* Anemia (Hgb \[men\] \</=12.5 gm/dL, Hgb \[women\] \</= 11 gm/dL)
* Thrombocytopenia (\</=130,000/mm(3))
* Hypoalbuminemia (\<3.4 g/dl)
* Elevated C-reactive protein (CRP) (CRP \> 3 mg/L)\] probably or definitely attributable to KSHV-MCD
* No life- or organ-threatening manifestations of MCD
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Human Immunodeficiency Virus (HIV)-infected patients should be receiving or willing to initiate an effective combination antiretroviral therapy (cART) regimen
* Willingness to complete tuberculosis evaluation and start prophylactic antituberculosis therapy as soon as is medically feasible if patients have a reactive tuberculin skin test and have not completed an adequate course of prevented anti-tuberculosis therapy, following American Tho…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With an Overall Clinical Benefit Response