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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.

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:
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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

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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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