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NCT01132911 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Vorinostat and Bortezomib in Children With Refractory of Recurrent Solid Tumors, Including CNS Tumors and Lymphomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01132911: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01132911 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01132911, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: \- Vorinostat and bortezomib are anti-tumor drugs that have been approved by the Food and Drug Administration to treat different kinds of myeloma and lymphoma in adults. The combination of these two drugs has been tried in a small number of adults, but it has not been formally approved and is experimental, particularly in children. Researchers are interested in determining safe and effective treatment doses of vorinostat and bortezomib in children, and learning more about how these drugs affect tumor growth and human development. Objectives: * To determine safe and effective doses of vorinostat and bortezomib to treat solid tumors in children. * To study the effects of vorinostat and bortezomib on blood cells, blood flow, and human development. Eligibility: \- Children, adolescents, and young adults between 1 and 21 years of age who have been diagnosed with solid tumors that have not responded to treatment. Design: * Eligible participants will be screened with a physical examination, blood and tumor samples, and imaging studies. * Participants will have 21-day treatment cycles of vorinostat and bortezomib. Vorinostat will be given as either tablets or liquid doses on days 1 through 5 and 8 through 12 of each cycle. Bortezomib will be given as an intravenous injection on days 1, 4, 8, and 11 of each cycle. Participants will keep a drug administration diary to record information about side effects or other problems with the treatment. * Participants may continue to receive vorinostat and bortezomib for up to 2 years unless serious side effects develop or the tumor does not respond to treatment. * Additional blood samples will be taken at regular intervals for the first 3 days after the first bortezomib dose and for the first 2 days after the first vorinostat dose of the first treatment cycle.
Interventions
- DRUG Vorinostat (SAHA)
- DRUG Velcade (PS-341, Bortezomib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-05-10 |
| Est. Completion | 2011-04-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01132911
The ClinicalTrials.gov registry entry for NCT01132911 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 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 2 interventions - of which Vorinostat (SAHA) is the first listed.
NCT01132911 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01132911 about?
NCT01132911 is a clinical study titled "A Phase I Study of Vorinostat and Bortezomib in Children With Refractory of Recurrent Solid Tumors, Including CNS Tumors and Lymphomas". Background: \- Vorinostat and bortezomib are anti-tumor drugs that have been approved by the Food and Drug Administration to treat different kinds of myeloma and lymphoma in adults. The combination of these two drugs has been tried in a small number of adults, but it has not been formally approved ...
What is the current status of trial NCT01132911?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-05-10. Estimated completion is 2011-04-13.
What interventions are being tested in trial NCT01132911?
The interventions under investigation include: Vorinostat (SAHA) (DRUG), Velcade (PS-341, Bortezomib) (DRUG).
Who is sponsoring clinical trial NCT01132911?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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