AzTrials
AzTrials

Head and Neck CancerPhase 3NCT00054561

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

A Phase 3 study testing recombinant interferon alfa, vitamin E and isotretinoin in people with Head and Neck Cancer, run by Eastern Cooperative Oncology Group at 89 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
recombinant interferon alfa, vitamin E and isotretinoin
Type of treatment
Surgery or procedure
How many people
Not given
Where
89 sitesin 5 countries
Study dates
26 Nov 2003to 1 May 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

89 sites in 5 countries.

89 sites in 5 countries

United States82 sites

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York, 11209

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611-4494

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316-2301

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Veterans Affairs Medical Center - Gainesville

    Gainesville, Florida, 32608-1197

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54307-3453

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Veterans Affairs Medical Center - Madison

    Madison, Wisconsin, 53705

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-0001

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Veterans Affairs Medical Center - Miami

    Miami, Florida, 33125

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226-3596

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417-2399

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

    Nashville, Tennessee, 37212-2637

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-6307

  • Cancer Institute of New Jersey at Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Veterans Affairs Medical Center - New York

    New York, New York, 10010

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Veterans Affairs Medical Center - Omaha

    Omaha, Nebraska, 68105

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Burgess Health Center

    Onawa, Iowa, 51040

  • Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, 94304-1290

  • Midlands Cancer Center at Midlands Community Hospital

    Papillion, Nebraska, 68128-4157

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615-7828

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, 19102-1192

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15236

  • Veterans Affairs Medical Center - Pittsburgh

    Pittsburgh, Pennsylvania, 15240

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Mayo Clinic Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Stanford Cancer Center at Stanford University Medical Center

    Stanford, California, 94305-5216

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Albert Einstein Clinical Cancer Center

    The Bronx, New York, 10461

  • MBCCOP-Our Lady of Mercy Cancer Center

    The Bronx, New York, 10466

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • MBCCOP - Howard University Cancer Center

    Washington D.C., District of Columbia, 20060

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Puerto Rico3 sites

  • MBCCOP - San Juan

    San Juan, 00921-3201

  • Veterans Affairs Medical Center - San Juan

    San Juan, 00927-5800

  • San Juan City Hospital

    San Juan, 00936-7344

Other trials in Puerto Rico

Australia2 sites

  • Westmead Breast Centre at NSW Breast Cancer Institute

    Westmead, New South Wales, 2145

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Peru1 site

  • Instituto de Enfermedades Neoplasicas

    Lima, 34

Other trials in Peru

South Africa1 site

  • Pretoria Academic Hospital

    Pretoria, 0001

Other trials in South Africa

About this study

Official title: 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.

Read the 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.

Being tested
recombinant interferon alfa, vitamin E, isotretinoin, adjuvant therapy
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
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interferon alfaBiological

  • vitamin EDietary supplement

  • isotretinoinDrug

  • adjuvant therapyProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2003 (estimated)
  2. Study start26 Nov 2003
  3. Primary completionDec 2004
  4. Study completion1 May 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054561
Sponsor's protocol ID
CDR0000271174
Other IDs
ECOG-1301
Status last verified
Jun 2023
First submitted
5 Feb 2003
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing recombinant interferon alfa, vitamin E and isotretinoin in people with Head and Neck Cancer, run by Eastern Cooperative Oncology Group at 89 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Puerto Rico, Australia, Peru, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00054561.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in