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

October 29, 2012 updated by: M.D. Anderson Cancer Center

A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Control (no treatment), conventional surgery.
Procedure: Neoadjuvant therapy
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.
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.
Procedure: Neoadjuvant therapy
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.
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 Names:
  • SCH 54031
Experimental: PEG-Intron 2.5 mg/kg
PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.
Procedure: Neoadjuvant therapy
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.
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 Names:
  • SCH 54031
Experimental: PEG-Intron 5.0 mg/kg
PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.
Procedure: Neoadjuvant therapy
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.
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 Names:
  • SCH 54031

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 3 weeks following treatment
3 weeks following treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Estimate)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 29, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000441020
  • MDA-ID-01450
  • ID01-450 (Other Identifier: MD Anderson Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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