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Trial record 37 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

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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ClinicalTrials.gov Identifier: NCT00276523
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : October 31, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE January 12, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date October 31, 2012
Study Start Date  ICMJE February 2004
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2012)
Response rate [ Time Frame: 3 weeks following treatment ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00276523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2012)
Toxicity [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Biological: 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.
    Other Name: SCH 54031
  • Procedure: 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.
  • Procedure: Neoadjuvant therapy
Study Arms  ICMJE
  • Active Comparator: Control
    Control (no treatment), conventional surgery.
    Interventions:
    • Procedure: Conventional surgery
    • Procedure: Neoadjuvant therapy
  • Experimental: PEG-Intron 0.5 mg/kg
    PEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.
    Interventions:
    • Biological: PEG-interferon alfa-2b
    • Procedure: Conventional surgery
    • Procedure: Neoadjuvant therapy
  • Experimental: PEG-Intron 2.5 mg/kg
    PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.
    Interventions:
    • Biological: PEG-interferon alfa-2b
    • Procedure: Conventional surgery
    • Procedure: Neoadjuvant therapy
  • Experimental: PEG-Intron 5.0 mg/kg
    PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.
    Interventions:
    • Biological: PEG-interferon alfa-2b
    • Procedure: Conventional surgery
    • Procedure: Neoadjuvant therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2012)
3
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276523
Other Study ID Numbers  ICMJE CDR0000441020
MDA-ID-01450
ID01-450 ( Other Identifier: MD Anderson Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Roy S. Herbst, MD, PhD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP