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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
Must not have
Presence of another malignancy requiring current treatment that would preclude the use of all of the study treatments or the ability to monitor the natural history of MCD untreated
Any abnormality that would be scored as NCI CTC Grade IV toxicity that is unrelated to HIV, its treatment, or to MCD that would preclude protocol treatment and/or observation only
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study closure
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have another cancer that needs treatment interfering with this study.
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I don't have severe health issues unrelated to HIV or my current condition that would stop me from following the study's treatment plan.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Describe natural history
Secondary study objectives
Number of flares
overall survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
13,925 Previous Clinical Trials
41,017,926 Total Patients Enrolled
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
Cancer Research Study Groups: Active Treament 3, Active Treatment 1, Active Treatment 2, Active Treatment 4, Active Treatment 5, Natural History
Cancer 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
~3 spots leftby Oct 2025
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