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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00276523 |
Purpose
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of head and neck cancer. It may also stop the growth of head and neck cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This randomized phase II trial is studying how well different doses of PEG-interferon alfa-2b work in treating patients with stage II, stage III, or stage IV head and neck cancer that can be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Biological: PEG-interferon alfa-2b Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck |
| Study Start Date: | February 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 4 treatment arms.
In arms II, III, and IV, patients undergo surgery within 1 week after completion of PEG-interferon alfa-2b.
After completion of study treatment, patients are followed for up to 30 days.
PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck
One of the following primary tumor sites:
Resectable disease
Scheduled to undergo surgery as primary treatment
PATIENT CHARACTERISTICS:
Hemoglobin ≥ 10 g/dL
No immunologically mediated disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Texas | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Principal Investigator: | Roy S. Herbst, MD, PhD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000441020, MDA-ID-01450 |
| Study First Received: | January 12, 2006 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00276523 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx |
stage IV squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx |
|
Interferon-alpha Anti-Infective Agents Immunologic Factors Antineoplastic Agents Growth Substances Interferons Physiological Effects of Drugs Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Peginterferon alfa-2b Growth Inhibitors Angiogenesis Modulating Agents Interferon Alfa-2a Interferon Alfa-2b |