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NCT01441063 · ClinicalTrials.gov registry record · Phase 2
Tocilizumab for KSHV-Associated Multicentric Castleman Disease
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01441063: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01441063 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01441063, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
Overall clinical benefit response is defined as Complete Response (CR): Full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to MCD, lasting at least 3 weeks; and Partial Response (PR): At least 50% of the abnormalities probably or definitely attributed to KSHV-MCD must improve by the minimum amounts specified to attain PR. Only abnormalities present in a specific patient at baseline may count
Interventions
- DRUG Zidovudine
- DRUG Tocilizumab
- DRUG Valganciclovir (VGC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-09-13 |
| Est. Completion | 2020-10-05 |
| Phase | Phase 2 |
What the finished NCT01441063 record still lists
NCT01441063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Zidovudine is the first listed.
NCT01441063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01441063 about?
NCT01441063 is a clinical study titled "Tocilizumab for KSHV-Associated Multicentric Castleman Disease". 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...
What is the current status of trial NCT01441063?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2011-09-13. Estimated completion is 2020-10-05.
What interventions are being tested in trial NCT01441063?
The interventions under investigation include: Zidovudine (DRUG), Tocilizumab (DRUG), Valganciclovir (VGC) (DRUG).
Who is sponsoring clinical trial NCT01441063?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01441063's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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