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NCT00048334 · ClinicalTrials.gov registry record · Phase 1
Depsipeptide to Treat Thyroid and Other Advanced Cancers
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00048334: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00048334 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00048334, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This phase I study will evaluate the experimental drug Romidepsinin patients with advanced cancer. The study will: 1) determine how well patients tolerate Romidepsin; 2) measure blood levels of Romidepsin during treatment; 3) analyze the cellular and molecular effects of the drug; and 4) determine if Romidepsin can shrink tumors. Romidepsin has been shown to kill cancer cells growing in the laboratory and to shrink tumors in animals with various tumor types. In preliminary studies, several patients with a type of lymphoma and one patient with kidney cancer responded to treatment. Patients 18 years of age and older with advanced cancer (excluding acute leukemia) may be eligible for this study. Candidates are screened with a medical history and physical examination, x-rays and CT scans, and blood and urine tests. Patients with thyroid cancer may also have magnetic resonance imaging (MRI). This test uses a magnetic field instead of x-rays to obtain images or body organs and tissues. Participants receive three infusions of Romidepsin administered through an intravenous line over 4 hours on days 1, 3 and 5 of a 21-day treatment cycle. The intravenous line is a catheter (plastic tube) placed in a vein and may be a peripheral line, inserted in a vein in the arm, or a central line, in which the tube is placed under the skin of the chest or neck into a major vein. Patients are hospitalized for the first 6 days of the first cycle to monitor heart rate. Those who tolerate the treatment well may continue as an outpatient. In addition to drug therapy, participants undergo the following procedures: * Blood tests: Small amounts of blood are drawn frequently during the first five days of treatment to measure Romidepsin levels and to see how the body uses and excretes the drug. A heparin lock (an indwelling device to keep the vein open) may be put in the vein to prevent the need for repeated needle sticks. * Biopsies (removal of a small sample of tumor tissue): Tumors that are a
Interventions
- DRUG Depsipeptide, FR901228, FK228
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2002-10-26 |
| Est. Completion | 2010-04-01 |
| Phase | Phase 1 |
What the finished NCT00048334 record still lists
NCT00048334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Depsipeptide, FR901228, FK228 is the first listed.
NCT00048334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00048334 about?
NCT00048334 is a clinical study titled "Depsipeptide to Treat Thyroid and Other Advanced Cancers". This phase I study will evaluate the experimental drug Romidepsinin patients with advanced cancer. The study will: 1) determine how well patients tolerate Romidepsin; 2) measure blood levels of Romidepsin during treatment; 3) analyze the cellular and molecular effects of the drug; and 4) determine i...
What is the current status of trial NCT00048334?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2002-10-26. Estimated completion is 2010-04-01.
What interventions are being tested in trial NCT00048334?
The interventions under investigation include: Depsipeptide, FR901228, FK228 (DRUG).
Who is sponsoring clinical trial NCT00048334?
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 NCT00048334's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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