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Experimental Therapies for KICS
Phase 2
Recruiting
Led By Robert Yarchoan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 Years
Exposure risk for KSHV infection (including being a first or second generation immigrant from an endemic area, or male-to-male sexual activity) or evidence of KSHV infection demonstrated by molecular evidence of KSHV in whole blood, immunohistochemical evidence of KSHV in tissues, or presence of KS or PEL (KSHV-associated malignancies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial is for people with KSHV inflammatory cytokine syndrome to get new experimental treatments, which may include antiviral drugs and chemotherapy drugs.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is studying how KSHV inflammatory cytokine syndrome (KICS) works and testing treatments including antiviral drugs like Valganiclovir and chemotherapy agents such as Rituximab, Zidovudine, Liposomal Doxorubicin against standard therapies.See study design
What are the potential side effects?
Possible side effects include reactions to infusions, lowered blood counts leading to increased infection risk, fatigue, nausea, liver issues from antivirals; plus hair loss, heart damage from chemotherapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am at risk for KSHV infection or have evidence of it.
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My HIV status is positive or negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Natural history of KICS
Secondary outcome measures
Participants with KICS
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: 6Experimental Treatment1 Intervention
Natural history
Group II: 5Experimental Treatment1 Intervention
Standard and alternative rational therapies (inactive)
Group III: 4Experimental Treatment2 Interventions
Rituximab with or without liposomal doxorubicin (inactive)
Group IV: 3Experimental Treatment2 Interventions
High dose zidovudine + valganciclovir (inactive)
Group V: 2Active Control1 Intervention
Natural history/Observation arm (inactive)
Group VI: 1Active Control1 Intervention
Evaluation for Alternative Causes of KICS Symptoms (inactive)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Zidovudine
2016
Completed Phase 4
~8000
Liposomal Doxorubicin
2013
Completed Phase 2
~570
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,541 Total Patients Enrolled
Robert Yarchoan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
1,500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am at risk for KSHV infection or have evidence of it.I have at least two symptoms from different categories that might be due to KICS and can't be explained by other conditions.I agree to use birth control during and after the study as required.I don't have severe health issues unrelated to HIV or KICS that would stop me from receiving the study treatments.My HIV status is positive or negative.
Research Study Groups:
This trial has the following groups:- Group 1: 6
- Group 2: 2
- Group 3: 4
- Group 4: 1
- Group 5: 5
- Group 6: 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the U.S. Food and Drug Administration accepted Zidovudine as a medically viable treatment option?
"Our assessment of zidovudine's safety is a 2, as it has yet to be clinically proven effective for its intended use but there are some data points that suggest the drug can be safely administered."
Answered by AI
Is there a cap on how many people can enroll in this study?
"Yes, the information hosted on clinicaltrials.gov confirms that this medical study is still recruiting participants. This investigation was initially unveiled on September 8th 2011 and has most recently been changed as of November 19th 2022; 80 individuals are expected to be sourced from 2 distinct centres for enrollment in the trial."
Answered by AI
In what patient population is Zidovudine most frequently recommended?
"Zidovudine is a common treatment of endometrial cancer in its advanced stages. Additionally, it has been used to prevent perinatal HIV transmission and chemotherapy for soft tissue sarcoma (STS)."
Answered by AI
Are there any open enrolment opportunities for this experiment?
"Indeed, the data available on clinicaltrials.gov verifies that recruitment for this medical experiment is ongoing; it was initially posted on September 8th 2011 and recently updated November 19th 2022. The total number of participants required across two sites stands at 80 individuals."
Answered by AI
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