Isotretinoin, Interferon Alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Public ClinicalTrials.gov record NCT00054561. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase III Randomized Study of Adjuvant Biologic Therapy in Patients With Stages III/IV Head and Neck Squamous Cell Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Drugs used in chemotherapy such as isotretinoin use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Vitamin E may be able to decrease side effects caused by isotretinoin. It is not yet known whether combining isotretinoin and interferon alfa with vitamin E is more effective than observation in preventing recurrence of head and neck cancer after surgery and/or radiation therapy. PURPOSE: Randomized phase III trial to compare the effectiveness of isotretinoin and interferon alfa combined with vitamin E with that of observation in treating patients who have undergone surgery and/or radiation therapy for stage III or stage IV head and neck cancer.
Study identification
- NCT ID
- NCT00054561
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
- recombinant interferon alfa Biological
- vitamin E Dietary Supplement
- isotretinoin Drug
- adjuvant therapy Procedure
Biological · Dietary Supplement · Drug + 1 more
Eligibility (public fields only)
- Age range
- 18 Years to 120 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 26, 2003 (Actual)
- Primary completion
- Dec 2004 (Actual)
- Completion
- May 1, 2009 (Actual)
- Last update posted
- Jun 15, 2023
2003 – 2009
United States locations
- U.S. sites
- 82
- U.S. states
- 30
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | — |
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale | Arizona | 85259-5404 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | — |
| Veterans Affairs Medical Center - Palo Alto | Palo Alto | California | 94304-1290 | — |
| Stanford Cancer Center at Stanford University Medical Center | Stanford | California | 94305-5216 | — |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | — |
| MBCCOP - Howard University Cancer Center | Washington D.C. | District of Columbia | 20060 | — |
| Veterans Affairs Medical Center - Gainesville | Gainesville | Florida | 32608-1197 | — |
| Veterans Affairs Medical Center - Miami | Miami | Florida | 33125 | — |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612-9497 | — |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida | 33612 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | 30033 | — |
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | 60611-4494 | — |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611 | — |
| CCOP - Central Illinois | Decatur | Illinois | 62526 | — |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | — |
| CCOP - Evanston | Evanston | Illinois | 60201 | — |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615-7828 | — |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | — |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | 46202 | — |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | — |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | — |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309-1016 | — |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | — |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316-2301 | — |
| Burgess Health Center | Onawa | Iowa | 51040 | — |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | — |
| Veterans Affairs Medical Center - Wichita | Wichita | Kansas | 67218 | — |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | — |
| Tufts - New England Medical Center | Boston | Massachusetts | 02111 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | — |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| CCOP - Duluth | Duluth | Minnesota | 55805 | — |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | 55417-2399 | — |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | — |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | — |
| Veterans Affairs Medical Center - Omaha | Omaha | Nebraska | 68105 | — |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | — |
| Midlands Cancer Center at Midlands Community Hospital | Papillion | Nebraska | 68128-4157 | — |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | — |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | — |
| Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | 07018 | — |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | — |
| Cancer Institute of New Jersey at Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | 87131 | — |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | 11209 | — |
| Veterans Affairs Medical Center - New York | New York | New York | 10010 | — |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York | 10016 | — |
| Albert Einstein Clinical Cancer Center | The Bronx | New York | 10461 | — |
| MBCCOP-Our Lady of Mercy Cancer Center | The Bronx | New York | 10466 | — |
| CCOP - Merit Care Hospital | Fargo | North Dakota | 58122 | — |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | — |
| CCOP - Columbus | Columbus | Ohio | 43206 | — |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43623-3456 | — |
| CCOP - Oklahoma | Tulsa | Oklahoma | 74136 | — |
| CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania | 17822-2001 | — |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102-1192 | — |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | — |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15236 | — |
| Veterans Affairs Medical Center - Pittsburgh | Pittsburgh | Pennsylvania | 15240 | — |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | — |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | 57104 | — |
| Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville | Tennessee | 37212-2637 | — |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee | 37232-6307 | — |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | — |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin | 54307-3453 | — |
| Veterans Affairs Medical Center - Madison | Madison | Wisconsin | 53705 | — |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-0001 | — |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | — |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226-3596 | — |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00054561, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 15, 2023 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00054561 live on ClinicalTrials.gov.