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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01441063
The ClinicalTrials.gov registry entry for NCT01441063 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Zidovudine is the first listed.
NCT01441063 reports 0 study locations.
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.
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