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Virus Therapy

Virotherapy for Castleman Disease

Phase 2
Waitlist Available
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
Biopsy proven KSHV-associated MCD, confirmed in the Laboratory of Pathology, CCR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study closure
Awards & highlights

Study Summary

This trial is studying a rare disorder caused by the Kaposi's sarcoma herpes virus (KSHV), which also causes several types of cancer. Researchers want to understand the biology of KSHV-associated multicentric Castleman's disease (MCD) to find ways to treat it.

Who is the study for?
Adults over 18 with biopsy-proven KSHV-associated multicentric Castleman's disease can join this study. Pregnant women and individuals with severe unrelated health issues, other active malignancies needing treatment, or conditions making the trial unsafe are excluded.Check my eligibility
What is being tested?
The trial is exploring treatments for a rare cancer-like condition caused by KSHV virus. It includes drugs like Zidovudine and Valganciclovir (which may affect bone marrow), Bortezomib (possible low blood pressure), Rituximab, Doxorubicin, Interferon-alpha (to boost immune response against the virus), and others.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, decreased bone marrow function leading to lower blood counts which could result in fatigue or increased infection risk; gastrointestinal problems; potential sterility; and defects in a fetus if pregnant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My condition is confirmed as KSHV-associated MCD by a pathology lab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study closure
This trial's timeline: 3 weeks for screening, Varies for treatment, and study closure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Describe natural history
Secondary outcome measures
Number of flares
overall survival

Trial Design

6Treatment groups
Active Control
Group I: Active Treament 3Active Control3 Interventions
Patients not responding to high- dose zidovudine and valganciclovir alone may be treated with botezomib plus high- dose zidovudine and valganciclovir
Group II: Active Treatment 1Active Control1 Intervention
Single agent sirolimus for patients where targeted oncolytic virotherapy seems suboptimal
Group III: Active Treatment 2Active Control7 Interventions
EPOCH chemotherapy with rituximab may be utilized to rescue such patients, with the intent of stabilizing suchpatients
Group IV: Active Treatment 4Active Control3 Interventions
Rituximab with liposomal doxorubicin (R-Dox) followed by consolidation or lmaintenancel therapy with dose escalating interferon-alpha
Group V: Active Treatment 5Active Control2 Interventions
High dose zidovudin and valganciclovir
Group VI: Natural HistoryActive Control1 Intervention
Observation Only

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,615 Previous Clinical Trials
40,918,545 Total Patients Enrolled
85 Trials studying Lymphoproliferative Disorders
67,907 Patients Enrolled for Lymphoproliferative Disorders
Robert Yarchoan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
1,565 Total Patients Enrolled

Media Library

Virotherapy (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00092222 — Phase 2
Lymphoproliferative Disorders Research Study Groups: Active Treament 3, Active Treatment 1, Active Treatment 2, Active Treatment 4, Active Treatment 5, Natural History
Lymphoproliferative Disorders Clinical Trial 2023: Virotherapy Highlights & Side Effects. Trial Name: NCT00092222 — Phase 2
Virotherapy (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00092222 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical issues have been addressed through Natural History approaches?

"Natural History is commonly prescribed to Merkel cell cancer patients, but has been found to be effective for the management of a wide array of malignancies including leukemia, ophthalmia, sympathetic and prostate cancers."

Answered by AI

Have any previous investigations explored the Natural History of this phenomenon?

"Currently, 1845 clinical studies are being conducted to examine the Natural History phenomenon. Of these trials, 406 have reached Phase 3 and there are 69332 sites that offer this therapy in Bethesda, Maryland alone."

Answered by AI

Is the research study currently open to new participants?

"This clinical trial, originally posted on October 28th 2004 and last amended November 19th 2022 is no longer enrolling participants. Nevertheless, there are 4915 other trials that remain open to recruitment."

Answered by AI

How many participants are currently undergoing treatment in this clinical experiment?

"This clinical trial is no longer actively searching for candidates. It was first posted on October 28th, 2004 and the last update occurred November 19th 2022. For those who are seeking other trials to participate in, there are currently 3070 studies looking for individuals with hhv-8 and 1845 Natural History investigations open to applicants."

Answered by AI

Has the FDA certified Natural History for its intended purpose?

"The safety of the Natural History trial was scored a 2 due to there being preliminary evidence in favour of its security, however no data validating its efficacy is available."

Answered by AI
Recent research and studies
~5 spots leftby Oct 2025