CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Zidovudine +2 moredrug
Likely dose
Zidovudine 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01441063
NCT01441063Phase 2Completed

Pilot Study of Tocilizumab in Patients With Symptomatic Kaposi Sarcoma Herpesvirus (KSHV) - Associated Multicentric Castleman Disease

National Cancer Institute (NCI)·interventional·Posted Sep 27, 2011·Updated Oct 27, 2020

In Brief

A Phase 2 clinical trial evaluating Zidovudine, Tocilizumab, and 1 other intervention for Castleman Disease and 2 related conditions. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2011
Enrollment StartSep 13, 2011
Primary CompletionJun 6, 2018
Study CompletionOct 5, 2020
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 14.8 years ago

Interventions

Zidovudinedrug

Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)

Tocilizumabdrug

Tocilizumab 8mg/kg every 2 weeks

Valganciclovir (VGC)drug

Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.