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NCT01274338 · ClinicalTrials.gov registry record · Phase 3
Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery
A Phase 3 study of Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 1,673
- Enrollment target
- 20
- Study locations
NCT01274338 is a Phase 3 study of Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 1,673 participants, above the 100-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (1573% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT01274338, a Phase 3 study of Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,673 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon alfa-2b in treating patients with melanoma.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- BIOLOGICAL Ipilimumab
- BIOLOGICAL Recombinant Interferon Alfa-2b
Study Locations (20)
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- John L McClellan Memorial Veterans Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Providence Hospital - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
Alaska
- Alaska Regional Hospital - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,673 participants |
| Start Date | 2011-05-25 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01274338
The ClinicalTrials.gov registry entry for NCT01274338 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,673 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 100-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (1573% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Recurrent Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01274338 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Arkansas, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01274338 about?
NCT01274338 is a clinical study titled "Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery". This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune sy...
What is the current status of trial NCT01274338?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,673 participants. The study started on 2011-05-25. Estimated completion is 2026-03-19.
What conditions does trial NCT01274338 study?
This clinical trial studies the following conditions: Recurrent Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Melanoma of Unknown Primary.
What interventions are being tested in trial NCT01274338?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Ipilimumab (BIOLOGICAL), Recombinant Interferon Alfa-2b (BIOLOGICAL).
Who is sponsoring clinical trial NCT01274338?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01274338 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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