- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00054561
Isotretinoin, Interferon Alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Phase III Randomized Study of Adjuvant Biologic Therapy in Patients With Stages III/IV Head and Neck Squamous Cell Carcinoma
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 Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine the efficacy of adjuvant isotretinoin, interferon alfa, and vitamin E, in terms of incidence of primary disease recurrence and secondary primary tumor development, in patients with stage III or IV squamous cell carcinoma of the head and neck previously treated with definitive surgical excision and/or postoperative radiotherapy.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Compare the overall and disease-free survival of patients treated with this regimen vs those who undergo observation only.
- Determine whether alterations of p53 gene, retinoic acid receptors, retinoid-regulated gene, and interferon-responsive genes are associated with clinical outcome in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T stage (T1 or T2 vs T3 or T4), N stage (N0 or N1 vs N2 or N3), prior therapy (complete tumor resection vs resection and radiotherapy/chemoradiotherapy vs radiotherapy or chemoradiotherapy alone), and prior chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral isotretinoin once daily, interferon alfa subcutaneously 3 times weekly, and oral vitamin E 3 times daily. Treatment repeats every month for 12 courses (1 year) in the absence of disease recurrence or unacceptable toxicity.
- Arm II: Patients undergo observation only for 1 year. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 376 patients (188 per treatment arm) will be accrued for this study within 3.75 years.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital
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Westmead, New South Wales, Australia, 2145
- Westmead Breast Centre at NSW Breast Cancer Institute
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Lima, Peru, 34
- Instituto De Enfermedades Neoplasicas
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San Juan, Puerto Rico, 00936-7344
- San Juan City Hospital
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San Juan, Puerto Rico, 00927-5800
- Veterans Affairs Medical Center - San Juan
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San Juan, Puerto Rico, 00921-3201
- MBCCOP - San Juan
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Pretoria, South Africa, 0001
- Pretoria Academic Hospital
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Alabama
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Birmingham, Alabama, United States, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Arizona
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Scottsdale, Arizona, United States, 85259-5404
- CCOP - Mayo Clinic Scottsdale Oncology Program
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California
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Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
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Palo Alto, California, United States, 94304-1290
- Veterans Affairs Medical Center - Palo Alto
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Stanford, California, United States, 94305-5216
- Stanford Cancer Center at Stanford University Medical Center
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Delaware
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Newark, Delaware, United States, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20060
- MBCCOP - Howard University Cancer Center
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Florida
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Gainesville, Florida, United States, 32608-1197
- Veterans Affairs Medical Center - Gainesville
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Miami, Florida, United States, 33125
- Veterans Affairs Medical Center - Miami
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Tampa, Florida, United States, 33612
- Veterans Affairs Medical Center - Tampa (Haley)
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute of Emory University
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Decatur, Georgia, United States, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Illinois
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Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago, Illinois, United States, 60611-4494
- Veterans Affairs Medical Center - Lakeside Chicago
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Evanston, Illinois, United States, 60201
- CCOP - Evanston
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Peoria, Illinois, United States, 61615-7828
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, United States, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, United States, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, United States, 50316-2301
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Onawa, Iowa, United States, 51040
- Burgess Health Center
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Kansas
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
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Louisiana
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New Orleans, Louisiana, United States, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Health Sciences Center
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Maryland
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Baltimore, Maryland, United States, 21231
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02111
- TUFTS - New England Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
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Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Minneapolis, Minnesota, United States, 55417-2399
- Veterans Affairs Medical Center - Minneapolis
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, United States, 68105
- Veterans Affairs Medical Center - Omaha
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Papillion, Nebraska, United States, 68128-4157
- Midlands Cancer Center at Midlands Community Hospital
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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East Orange, New Jersey, United States, 07018
- Veterans Affairs Medical Center - East Orange
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Hackensack, New Jersey, United States, 07601
- CCOP - Northern New Jersey
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New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Bronx, New York, United States, 10461
- Albert Einstein Clinical Cancer Center
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Bronx, New York, United States, 10466
- MBCCOP-Our Lady of Mercy Cancer Center
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Brooklyn, New York, United States, 11209
- Veterans Affairs Medical Center - Brooklyn
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New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, United States, 10010
- Veterans Affairs Medical Center - New York
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North Dakota
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Fargo, North Dakota, United States, 58122
- CCOP - Merit Care Hospital
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, United States, 44109
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- CCOP - Oklahoma
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Hershey, Pennsylvania, United States, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19102-1192
- Hahnemann University Hospital
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Pittsburgh, Pennsylvania, United States, 15240
- Veterans Affairs Medical Center - Pittsburgh
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Pittsburgh, Pennsylvania, United States, 15236
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
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Wynnewood, Pennsylvania, United States, 19096
- CCOP - MainLine Health
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- CCOP - Sioux Community Cancer Consortium
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Tennessee
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Nashville, Tennessee, United States, 37232-6307
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
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Nashville, Tennessee, United States, 37212-2637
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
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Texas
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Wisconsin
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Green Bay, Wisconsin, United States, 54307-3453
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Madison, Wisconsin, United States, 53705
- Veterans Affairs Medical Center - Madison
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Madison, Wisconsin, United States, 53792-0001
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, United States, 54449
- CCOP - Marshfield Clinic Research Foundation
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Milwaukee, Wisconsin, United States, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Milwaukee, Wisconsin, United States, 53226-3596
- Medical College of Wisconsin Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck
- Primary site must be within the oral cavity, oropharynx, larynx, or hypopharynx
- Stage III or IV primary lesion at diagnosis
- No distant metastatic disease at diagnosis
- No multiple primary lesions
Currently disease-free after treatment with 1 of the following:
- Complete tumor resection
- Radiotherapy or chemoradiotherapy alone*
- Resection followed by radiotherapy/chemoradiotherapy*
- No more than 4-16 weeks since prior surgery and/or radiotherapy/chemoradiotherapy NOTE: *Radiotherapy must have been 70-72 Gy in 1.8-2.0 Gy fractions to the primary tumor and clinically positive neck nodes and 44-50 Gy in 1.8-2.0 Gy fractions to clinically negative nodes, including the lower neck
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT no greater than 2 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2 times ULN
Renal
- Creatinine no greater than 1.2 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 1 month prior to, during, and for 1 month after study therapy
- Electrolytes normal
- Fasting serum triglyceride level no greater than 2 times ULN (anti-triglyceride medication allowed)
- No other malignancy within the past 2 years except localized basal cell or squamous cell skin cancer
- No other concurrent medical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
At least 4 weeks since prior chemotherapy and recovered
- Prior neoadjuvant chemotherapy allowed
- Prior chemotherapy administered concurrently with radiotherapy allowed
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- No history of megadose vitamin A (more than 25,000 I.U.)
- No other clinical trial enrollment that would preclude adjuvant systemic therapy
- No concurrent vitamin supplements containing vitamin A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Dong M. Shin, MD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Dermatologic Agents
- Micronutrients
- Vitamins
- Antioxidants
- Interferons
- Interferon-alpha
- Vitamin E
- Isotretinoin
Other Study ID Numbers
- CDR0000271174
- ECOG-1301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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