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Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical research trials and Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer. Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
For Condition: Laryngeal Cancer,Oropharyngeal Cancer,lip and oral cavity cancer,Hypopharyngeal Cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase 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.
Details: 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 4 weeks for 13 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DongShin, Study Chair, University of Pittsburgh Cancer Institute
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Veterans Affairs Medical Center - Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15240
United States
Recruiting Timothy Carlos 412-688-6248
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Robert Dalton 218-786-8364
NSW Breast Cancer Institute *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Michael Barton 61-2-9845-5555
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patrick Loehrer 317-278-7418
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
Pretoria Academic Hospital *Recruiting*
Pretoria, , 0001
South Africa
Recruiting Coenraad Slabber 27-12-354-1054
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Cancer Answers 800-456-7121
Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Roscoe Morton 515-247-3121
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Fadlo Khuri 404-778-5180
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5216
United States
Recruiting Harlan Pinto 650-725-9057
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Camilo Fadul 603-650-6312
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
Veterans Affairs Medical Center - East Orange *Recruiting*
East Orange, New Jersey, 07019
United States
Recruiting Basil Kasimis 973-676-1000 ext. 1544
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting George Adams 612-625-2410
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Robert Dreicer 216-445-4623
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
Veterans Affairs Medical Center - Indianapolis (Roudebush) *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Patrick Loehrer 317-554-0000
Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita, Kansas, 67218
United States
Recruiting Shaker Dakhil 316-685-2221
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Veterans Affairs Medical Center - Brooklyn *Recruiting*
Brooklyn, New York, 11209
United States
Recruiting Andrea Wiesel Leaf 718-630-3691
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
Burgess Health Center *Recruiting*
Onawa, Iowa, 51040
United States
Recruiting James Mailliard 712-423-2311
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting James Lockhart 918-491-5878
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
Veterans Affairs Medical Center - San Juan *Recruiting*
San Juan, , 00927-5800
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Cathcart 505-272-5688
Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion, Nebraska, 68128-4157
United States
Recruiting James Mailliard 402-593-3000
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting John Kirkwood 412-692-4724
Veterans Affairs Medical Center - Palo Alto *Recruiting*
Palo Alto, California, 94304-1290
United States
Recruiting Harlan Pinto 650-493-5000 ext. 4948
Veterans Affairs Medical Center - Omaha *Recruiting*
Omaha, Nebraska, 68105
United States
Recruiting James Mailliard 402-280-5274
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
Veterans Affairs Medical Center - Miami *Recruiting*
Miami, Florida, 33125
United States
Recruiting Niramol Savaraj 305-324-3143
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
Drexel University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19102-1192
United States
Recruiting Pamela Crilley 215-762-8547
Westmead Hospital *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Richard Kefford 61-2-9845-6033
Veterans Affairs Medical Center - Tampa (Haley) *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Julie Kish 813-972-2000
Veterans Affairs Medical Center - Gainesville *Recruiting*
Gainesville, Florida, 32608-1197
United States
Recruiting Dean McCarley 352-374-6016
MBCCOP - San Juan *Recruiting*
San Juan, , 00921-3201
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
Veterans Affairs Medical Center - Atlanta (Decatur) *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Maria Amarante Ribeiro 404-728-7680
San Juan City Hospital *Recruiting*
San Juan, , 00936-7344
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-241-4245
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Arlene Forastiere 410-955-9818
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417-2399
United States
Recruiting Markus Gapany 612-725-2000 ext. 3459
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
Iowa Lutheran Hospital *Recruiting*
Des Moines, Iowa, 50316-2301
United States
Recruiting Roscoe Morton 515-663-5612
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Carla Falkson 205-975-2691
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6307
United States
Recruiting David Johnson 615-343-9454
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus *Recruiting*
Nashville, Tennessee, 37212-2637
United States
Recruiting Kenneth Hande 615-327-4751
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Theodore Krontiris 626-301-8164
Veterans Affairs Medical Center - Madison *Recruiting*
Madison, Wisconsin, 53705
United States
Recruiting Mark Albertini 608-262-7017
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee, Wisconsin, 53295
United States
Recruiting Mohammed Raheem 414-384-2000
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Veterans Affairs Medical Center - New York *Recruiting*
New York City, New York, 10010
United States
Recruiting Howard Hochster 212-652-1912
Additional Information:
Study ID Numbers: CDR0000271174; ECOG-1301
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054561
Other Hypopharyngeal Cancer Studies:
1. Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
2. Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
3. Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
4. Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer
5. Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia
Related Studies:
Other Hypopharyngeal Cancer Clinical Trials
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Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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