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PEG-interferon Alfa-2b in Treating Patients With Stage II, Stage III, or Stage IV Head and Neck Cancer That Can Be Removed By Surgery

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PEG-interferon alfa-2b
Conventional surgery
Neoadjuvant therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck Stage II, III, or IV disease One of the following primary tumor sites: Oral cavity Oropharynx Hypopharynx Larynx Resectable disease Scheduled to undergo surgery as primary treatment Distant metastases or a second primary tumor allowed provided tumor deemed resectable by the surgeon No squamous cell carcinoma of the nasopharynx or skin PATIENT CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status 0-2 White Blood Cells (WBC) > 3,000/mm^3 Platelet count ≥ 150,000/mm^3 Hemoglobin ≥ 10 g/dL Transfusion and/or epoetin alfa support allowed provided it is given ≥ 1 week before study entry AND the patient is stable Bilirubin < 1.5 times upper limit of normal (ULN) serum glutamic pyruvic transaminase (SGPT) ≤ 5 times ULN Creatinine < 1.5 times ULN No hemolytic anemia No hemoglobinopathies (e.g., thalassemia) No prior or current ascites No bleeding varices No other evidence of decompensated liver disease No symptomatic ischemic heart disease No symptomatic congestive heart failure No other uncontrolled heart condition No chronic obstructive pulmonary disease No documented pulmonary hypertension No other chronic pulmonary disease No known HIV positivity No AIDS-related illness No active uncontrolled infection No immunologically mediated disease, including any of the following: Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) Rheumatoid arthritis Idiopathic thrombocytopenia purpura Systemic lupus erythematosus Autoimmune hemolytic anemia Scleroderma Severe psoriasis No Central Nervous System (CNS) trauma No confusion or disorientation No active seizure disorders requiring medication No spontaneous encephalopathy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No pre-existing uncontrolled thyroid abnormality No poorly controlled diabetes mellitus No history of major psychiatric illness that would prelude giving informed consent No nonmalignant systemic disease that would preclude study participation PRIOR CONCURRENT THERAPY: More than 4 weeks since prior biologic therapy and recovered More than 4 weeks since prior chemotherapy and recovered More than 4 weeks since prior radiotherapy and recovered More than 4 weeks since prior surgery No prior interferon No other concurrent immunotherapy No concurrent chemotherapy No concurrent hormonal antineoplastic therapy No concurrent systemic corticosteroids No concurrent radiotherapy

Sites / Locations

  • M.D. Anderson Cancer Center at University of Texas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Control

PEG-Intron 0.5 mg/kg

PEG-Intron 2.5 mg/kg

PEG-Intron 5.0 mg/kg

Arm Description

Control (no treatment), conventional surgery.

PEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.

PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.

PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Toxicity

Full Information

First Posted
January 12, 2006
Last Updated
October 29, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00276523
Brief Title
PEG-interferon Alfa-2b in Treating Patients With Stage II, Stage III, or Stage IV Head and Neck Cancer That Can Be Removed By Surgery
Official Title
A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: SCH 54031 (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.
Detailed Description
OBJECTIVES: Primary Determine the antiangiogenic effects of PEG-interferon alfa-2b, in terms of pre- and post-treatment levels of microvessel density (MVD), endothelial cell apoptosis, vascular endothelial growth factor (VEGF), interleukin-8, basic fibroblast growth factor (bFGF), Nuclear Factor-KappaB (NF-KB), matrix metalloproteinase/MMP-9, and NF-KB in biopsy specimens, from patients with resectable stage II-IV squamous cell carcinoma of the head and neck. Secondary Determine the toxicity profile of this drug in these patients. Determine the clinical response in patients treated with this drug. OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 4 treatment arms. Arm I: Patients undergo surgery within 3 weeks after randomization. Arm II: Patients receive PEG-interferon alfa-2b subcutaneously on days 1, 8, and 15. Arm III: Patients receive PEG-interferon alfa-2b as in arm II but at a higher dose. Arm IV: Patients receive PEG-interferon alfa-2b as in arm II but at a higher dose than in arm III. 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.

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 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control (no treatment), conventional surgery.
Arm Title
PEG-Intron 0.5 mg/kg
Arm Type
Experimental
Arm Description
PEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.
Arm Title
PEG-Intron 2.5 mg/kg
Arm Type
Experimental
Arm Description
PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.
Arm Title
PEG-Intron 5.0 mg/kg
Arm Type
Experimental
Arm Description
PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.
Intervention Type
Biological
Intervention Name(s)
PEG-interferon alfa-2b
Other Intervention Name(s)
SCH 54031
Intervention Description
Study medication begins on Day 1 and taken subcutaneously once each week with the last dose being taken within 1 week prior to surgery or biopsy.
Intervention Type
Procedure
Intervention Name(s)
Conventional surgery
Intervention Description
Participants on the control arm may undergo surgery at anytime within 3 weeks of randomization, and those randomized to PEG-Intron will undergo surgery on Days 16-22 following initiation of treatment.
Intervention Type
Procedure
Intervention Name(s)
Neoadjuvant therapy
Primary Outcome Measure Information:
Title
Response rate
Time Frame
3 weeks following treatment
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck Stage II, III, or IV disease One of the following primary tumor sites: Oral cavity Oropharynx Hypopharynx Larynx Resectable disease Scheduled to undergo surgery as primary treatment Distant metastases or a second primary tumor allowed provided tumor deemed resectable by the surgeon No squamous cell carcinoma of the nasopharynx or skin PATIENT CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status 0-2 White Blood Cells (WBC) > 3,000/mm^3 Platelet count ≥ 150,000/mm^3 Hemoglobin ≥ 10 g/dL Transfusion and/or epoetin alfa support allowed provided it is given ≥ 1 week before study entry AND the patient is stable Bilirubin < 1.5 times upper limit of normal (ULN) serum glutamic pyruvic transaminase (SGPT) ≤ 5 times ULN Creatinine < 1.5 times ULN No hemolytic anemia No hemoglobinopathies (e.g., thalassemia) No prior or current ascites No bleeding varices No other evidence of decompensated liver disease No symptomatic ischemic heart disease No symptomatic congestive heart failure No other uncontrolled heart condition No chronic obstructive pulmonary disease No documented pulmonary hypertension No other chronic pulmonary disease No known HIV positivity No AIDS-related illness No active uncontrolled infection No immunologically mediated disease, including any of the following: Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) Rheumatoid arthritis Idiopathic thrombocytopenia purpura Systemic lupus erythematosus Autoimmune hemolytic anemia Scleroderma Severe psoriasis No Central Nervous System (CNS) trauma No confusion or disorientation No active seizure disorders requiring medication No spontaneous encephalopathy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No pre-existing uncontrolled thyroid abnormality No poorly controlled diabetes mellitus No history of major psychiatric illness that would prelude giving informed consent No nonmalignant systemic disease that would preclude study participation PRIOR CONCURRENT THERAPY: More than 4 weeks since prior biologic therapy and recovered More than 4 weeks since prior chemotherapy and recovered More than 4 weeks since prior radiotherapy and recovered More than 4 weeks since prior surgery No prior interferon No other concurrent immunotherapy No concurrent chemotherapy No concurrent hormonal antineoplastic therapy No concurrent systemic corticosteroids No concurrent radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy S. Herbst, MD, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center Official Website

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PEG-interferon Alfa-2b in Treating Patients With Stage II, Stage III, or Stage IV Head and Neck Cancer That Can Be Removed By Surgery

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