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Isotretinoin, Interferon Alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer

Intervention: recombinant interferon alfa (Biological); vitamin E (Dietary Supplement); isotretinoin (Drug); adjuvant therapy (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Dong M. Shin, MD, Study Chair, Affiliation: Winship Cancer Institute of Emory University


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.

Clinical Details

Official title: Phase III Randomized Study of Adjuvant Biologic Therapy in Patients With Stages III/IV Head and Neck Squamous Cell Carcinoma

Study design: Allocation: Randomized, Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Creatinine no greater than 1. 2 mg/dL


- 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


- Not specified


- 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


- See Disease Characteristics

- Recovered from prior radiotherapy


- See Disease Characteristics

- Recovered from prior surgery


- 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

Locations and Contacts

Instituto de Enfermedades Neoplasicas, Lima 34, Peru

MBCCOP - San Juan, San Juan 00921-3201, Puerto Rico

San Juan City Hospital, San Juan 00936-7344, Puerto Rico

Veterans Affairs Medical Center - San Juan, San Juan 00927-5800, Puerto Rico

Pretoria Academic Hospital, Pretoria 0001, South Africa

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294-3300, United States

CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States

City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States

Veterans Affairs Medical Center - Palo Alto, Palo Alto, California 94304-1290, United States

Stanford Cancer Center at Stanford University Medical Center, Stanford, California 94305-5216, United States

CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States

MBCCOP - Howard University Cancer Center, Washington, District of Columbia 20060, United States

Veterans Affairs Medical Center - Gainesville, Gainesville, Florida 32608-1197, United States

Veterans Affairs Medical Center - Miami, Miami, Florida 33125, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612-9497, United States

Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida 33612, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia 30322, United States

Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia 30033, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611, United States

Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois 60611-4494, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois 62526, United States

CCOP - Evanston, Evanston, Illinois 60201, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615-7828, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

Indiana University Cancer Center, Indianapolis, Indiana 46202-5289, United States

Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana 46202, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa 50316-2301, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa 50314, United States

Burgess Health Center, Onawa, Iowa 51040, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States

CCOP - Ochsner, New Orleans, Louisiana 70121, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Tufts - New England Medical Center, Boston, Massachusetts 02111, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota 55417-2399, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Veterans Affairs Medical Center - Omaha, Omaha, Nebraska 68105, United States

Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska 68128-4157, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756-0002, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey 07018, United States

CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States

Cancer Institute of New Jersey at Robert Wood Johnson University Hospital, New Brunswick, New Jersey 08903, United States

MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico 87131, United States

Westmead Breast Centre at NSW Breast Cancer Institute, Westmead, New South Wales 2145, Australia

Westmead Hospital, Westmead, New South Wales 2145, Australia

Albert Einstein Clinical Cancer Center, Bronx, New York 10461, United States

MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York 10466, United States

Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York 11209, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York 10016, United States

Veterans Affairs Medical Center - New York, New York, New York 10010, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States

MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio 44109, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Toledo Community Hospital, Toledo, Ohio 43623-3456, United States

CCOP - Oklahoma, Tulsa, Oklahoma 74136, United States

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111-2497, United States

Hahnemann University Hospital, Philadelphia, Pennsylvania 19102-1192, United States

Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15236, United States

Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania 15240, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee 37232-6307, United States

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee 37212-2637, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54307-3453, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792-0001, United States

Veterans Affairs Medical Center - Madison, Madison, Wisconsin 53705, United States

CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States

Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin 53226-3596, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin 53295, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 2003
Last updated: February 6, 2009

Page last updated: August 23, 2015

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