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NCT01445340 · ClinicalTrials.gov registry record · Phase 1
Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01445340: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01445340 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445340, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Background: * Cutaneous T-cell lymphoma (CTCL) is a rare, slow-growing form of skin cancer. The cancer cells are found in red, scaly patches that may sometimes itch. * Early-stage CTCL is usually treated with topical therapies, which may lose effectiveness over time and have adverse effects, such as risk of secondary skin cancers and difficulty of use. * Romidepsin is an experimental drug that, given through a vein, has improved CTCL in some patients with later stages of the disease. * A topical ointment form of romidepsin may be helpful in treating early-stage CTCL. Objectives: * To determine the highest tolerated dose of topical romidepsin that can be given to patients with early-stage CTCL. * To evaluate the effectiveness of topical romidepsin in patients with early-stage CTCL. * To determine how the body handles topical romidepsin. Eligibility: -Patients 18 of age and older with early-stage CTCL. Design: * Study Part 1: Successive groups of 3 patients are treated with increasingly higher concentrations of topical romidepsin until the highest tolerated dose is found. * Study Part II: The highest tolerated dose, as determined in Part I, is applied to larger areas of skin in another group of patients. * All study participants apply the study medicine to their skin three times a day for 4 weeks. * During treatment, participants are monitored at weeks 2 and 4 with a history and physical examination, blood tests, electrocardiogram, skin biopsies and photographs of the skin. * After stopping treatment, participants return to the clinic at weeks 6 and 8 for blood tests and to see how the study medication is affecting the body.
Interventions
- DRUG Romidepsin (FR901228)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-04-21 |
| Est. Completion | 2012-06-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01445340
The ClinicalTrials.gov registry entry for NCT01445340 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 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 1 intervention - of which Romidepsin (FR901228) is the first listed.
NCT01445340 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01445340 about?
NCT01445340 is a clinical study titled "Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma". Background: * Cutaneous T-cell lymphoma (CTCL) is a rare, slow-growing form of skin cancer. The cancer cells are found in red, scaly patches that may sometimes itch. * Early-stage CTCL is usually treated with topical therapies, which may lose effectiveness over time and have adverse effects, such a...
What is the current status of trial NCT01445340?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2007-04-21. Estimated completion is 2012-06-29.
What interventions are being tested in trial NCT01445340?
The interventions under investigation include: Romidepsin (FR901228) (DRUG).
Who is sponsoring clinical trial NCT01445340?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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