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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00276523
First received: January 12, 2006
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Biological: PEG-interferon alfa-2b
Procedure: Conventional surgery
Procedure: Neoadjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 3 weeks following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: February 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Control (no treatment), conventional surgery.
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
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.
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
Experimental: PEG-Intron 2.5 mg/kg
PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.
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
Experimental: PEG-Intron 5.0 mg/kg
PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276523

Locations
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Roy S. Herbst, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00276523     History of Changes
Obsolete Identifiers: NCT00078416
Other Study ID Numbers: CDR0000441020, MDA-ID-01450, ID01-450
Study First Received: January 12, 2006
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Interferon-alpha
Interferons
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 31, 2014