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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
recombinant interferon alfa
vitamin E
isotretinoin
adjuvant therapy
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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 larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • CCOP - Mayo Clinic Scottsdale Oncology Program
  • City of Hope Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Palo Alto
  • Stanford Cancer Center at Stanford University Medical Center
  • CCOP - Christiana Care Health Services
  • MBCCOP - Howard University Cancer Center
  • Veterans Affairs Medical Center - Gainesville
  • Veterans Affairs Medical Center - Miami
  • H. Lee Moffitt Cancer Center and Research Institute
  • Veterans Affairs Medical Center - Tampa (Haley)
  • Winship Cancer Institute of Emory University
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Veterans Affairs Medical Center - Lakeside Chicago
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • CCOP - Central Illinois
  • Decatur Memorial Hospital Cancer Care Institute
  • CCOP - Evanston
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • Indiana University Cancer Center
  • Veterans Affairs Medical Center - Indianapolis (Roudebush)
  • CCOP - Northern Indiana CR Consortium
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
  • Burgess Health Center
  • CCOP - Wichita
  • Veterans Affairs Medical Center - Wichita
  • MBCCOP - LSU Health Sciences Center
  • CCOP - Ochsner
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Tufts - New England Medical Center
  • Beth Israel Deaconess Medical Center
  • CCOP - Michigan Cancer Research Consortium
  • CCOP - Kalamazoo
  • West Michigan Cancer Center
  • CCOP - Duluth
  • Veterans Affairs Medical Center - Minneapolis
  • University of Minnesota Cancer Center
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • Veterans Affairs Medical Center - Omaha
  • CCOP - Missouri Valley Cancer Consortium
  • Midlands Cancer Center at Midlands Community Hospital
  • CCOP - Southern Nevada Cancer Research Foundation
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Veterans Affairs Medical Center - East Orange
  • CCOP - Northern New Jersey
  • Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
  • MBCCOP - University of New Mexico HSC
  • Albert Einstein Clinical Cancer Center
  • MBCCOP-Our Lady of Mercy Cancer Center
  • Veterans Affairs Medical Center - Brooklyn
  • Veterans Affairs Medical Center - New York
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • CCOP - Merit Care Hospital
  • MetroHealth's Cancer Care Center at MetroHealth Medical Center
  • Cleveland Clinic Taussig Cancer Center
  • CCOP - Columbus
  • CCOP - Toledo Community Hospital
  • CCOP - Oklahoma
  • CCOP - Geisinger Clinic and Medical Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Hahnemann University Hospital
  • Abramson Cancer Center of the University of Pennsylvania
  • Fox Chase Cancer Center
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
  • Veterans Affairs Medical Center - Pittsburgh
  • CCOP - MainLine Health
  • CCOP - Sioux Community Cancer Consortium
  • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • CCOP - Scott and White Hospital
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • Veterans Affairs Medical Center - Madison
  • University of Wisconsin Comprehensive Cancer Center
  • CCOP - Marshfield Clinic Research Foundation
  • Medical College of Wisconsin Cancer Center
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)
  • Westmead Breast Centre at NSW Breast Cancer Institute
  • Westmead Hospital
  • Instituto de Enfermedades Neoplasicas
  • MBCCOP - San Juan
  • Veterans Affairs Medical Center - San Juan
  • San Juan City Hospital
  • Pretoria Academic Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
June 13, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00054561
Brief Title
Isotretinoin, Interferon Alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Official Title
Phase III Randomized Study of Adjuvant Biologic Therapy in Patients With Stages III/IV Head and Neck Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 26, 2003 (Actual)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
May 1, 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
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 larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin E
Intervention Type
Drug
Intervention Name(s)
isotretinoin
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong M. Shin, MD
Organizational Affiliation
Emory University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
CCOP - Mayo Clinic Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Veterans Affairs Medical Center - Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
Stanford Cancer Center at Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5216
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
MBCCOP - Howard University Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Veterans Affairs Medical Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1197
Country
United States
Facility Name
Veterans Affairs Medical Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Veterans Affairs Medical Center - Tampa (Haley)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Veterans Affairs Medical Center - Atlanta (Decatur)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-4494
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Veterans Affairs Medical Center - Indianapolis (Roudebush)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316-2301
Country
United States
Facility Name
Burgess Health Center
City
Onawa
State/Province
Iowa
ZIP/Postal Code
51040
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
Veterans Affairs Medical Center - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417-2399
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Veterans Affairs Medical Center - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Midlands Cancer Center at Midlands Community Hospital
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68128-4157
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
MBCCOP - University of New Mexico HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Albert Einstein Clinical Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
MBCCOP-Our Lady of Mercy Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Veterans Affairs Medical Center - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Facility Name
Veterans Affairs Medical Center - New York
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
MetroHealth's Cancer Care Center at MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1192
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Veterans Affairs Medical Center - Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3453
Country
United States
Facility Name
Veterans Affairs Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Westmead Breast Centre at NSW Breast Cancer Institute
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Instituto de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
MBCCOP - San Juan
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
Facility Name
Veterans Affairs Medical Center - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico
Facility Name
San Juan City Hospital
City
San Juan
ZIP/Postal Code
00936-7344
Country
Puerto Rico
Facility Name
Pretoria Academic Hospital
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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