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
NCT ID: NCT00276523
Last Updated: 2012-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
3 participants
INTERVENTIONAL
2004-02-29
2006-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control
Control (no treatment), conventional surgery.
Conventional surgery
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.
Neoadjuvant therapy
PEG-Intron 0.5 mg/kg
PEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.
PEG-interferon alfa-2b
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.
Conventional surgery
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.
Neoadjuvant therapy
PEG-Intron 2.5 mg/kg
PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.
PEG-interferon alfa-2b
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.
Conventional surgery
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.
Neoadjuvant therapy
PEG-Intron 5.0 mg/kg
PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.
PEG-interferon alfa-2b
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.
Conventional surgery
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.
Neoadjuvant therapy
Interventions
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PEG-interferon alfa-2b
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.
Conventional surgery
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.
Neoadjuvant therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Roy S. Herbst, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center Official Website
Other Identifiers
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MDA-ID-01450
Identifier Type: -
Identifier Source: secondary_id
ID01-450
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000441020
Identifier Type: -
Identifier Source: org_study_id
NCT00078416
Identifier Type: -
Identifier Source: nct_alias