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NCT00109005 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma
A Phase 2 study of Melanoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT00109005 is a Phase 2 study of Melanoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00109005, a Phase 2 study of Melanoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test whether an experimental drug called Revlimid (lenalidomide) can reduce tumor size and prolong survival in patients with metastatic melanoma (melanoma that has spread beyond the original tumor site). It will also examine the toxicity and blood effects of Revlimid. Patients 18 years of age and older with stage IV ocular melanoma may be eligible for this study. Candidates are screened with a medical history and physical and examination, blood and urine tests, electrocardiogram, chest x-ray, computed tomography (CT) scan and other imaging scans if needed, such as a bone scan, magnetic resonance imaging (MRI), ultrasound, or positron emission tomography (PET). Participants are admitted to the National Institutes of Health (NIH) Clinical Center for 24 hours for their first oral dose of Revlimid. During the hospital stay, blood is drawn before the dose is given and again at 0.25, 0.5, 1, 2, 4, 6, 9, 12 and 24 hours after dosing to see how the body handles the drug. If the drug is well tolerated, patients are sent home with a 21-day supply of drug to take once a day for 21 days, then go off drug 7 days. This regimen constitutes one 28-day treatment cycle. Treatment cycles may continue for up to 2 years. Patients keep a daily diary of side effects and have blood drawn once a week. The drug dose may be adjusted according to the laboratory test results. If unacceptable toxicity occurs, treatment may be stopped. Patients who agree to be biopsied undergo this procedure before treatment begins and at the end of treatment cycles 3 and 6. A small area of skin is numbed with medicine and a small piece of tumor is removed with a needle or by a small cut in the tumor. The tissue is examined under a microscope. Patients return to NIH after the first month of treatment and then every 3 months to evaluate their tumors and treatment of side effects. The visits include a physical examination, x-rays and scans to evaluate tumors. Visits are scheduled every 3 months
Conditions Studied
Interventions
- DRUG Revlimid
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2005-04 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00109005
The ClinicalTrials.gov registry entry for NCT00109005 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (98% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Revlimid is the first listed.
NCT00109005 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00109005 about?
NCT00109005 is a clinical study titled "Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma". This study will test whether an experimental drug called Revlimid (lenalidomide) can reduce tumor size and prolong survival in patients with metastatic melanoma (melanoma that has spread beyond the original tumor site). It will also examine the toxicity and blood effects of Revlimid. Patients 18 ye...
What is the current status of trial NCT00109005?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2005-04. Estimated completion is 2009-04.
What conditions does trial NCT00109005 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT00109005?
The interventions under investigation include: Revlimid (DRUG).
Who is sponsoring clinical trial NCT00109005?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00109005 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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