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Head and Neck CancerPhase 2NCT00276523

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

A Phase 2 study testing PEG-interferon alfa-2b, Conventional surgery and Neoadjuvant therapy in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
PEG-interferon alfa-2b, Conventional surgery and Neoadjuvant therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Feb 2004to Mar 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Houston, Texas, 77030-4009

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
PEG-interferon alfa-2b, Conventional surgery, Neoadjuvant therapy
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
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG-interferon alfa-2bBiological

    Also called SCH 54031

    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 surgeryProcedure or 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 therapyProcedure or surgery

Study groups in NCT00276523
Study groupRoleWhat they receive
ControlActive comparatorControl (no treatment), conventional surgery.
Receives: Procedure: Conventional surgery; Procedure: Neoadjuvant therapy
PEG-Intron 0.5 mg/kgExperimentalPEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.
Receives: Biological: PEG-interferon alfa-2b; Procedure: Conventional surgery; Procedure: Neoadjuvant therapy
PEG-Intron 2.5 mg/kgExperimentalPEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.
Receives: Biological: PEG-interferon alfa-2b; Procedure: Conventional surgery; Procedure: Neoadjuvant therapy
PEG-Intron 5.0 mg/kgExperimentalPEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.
Receives: Biological: PEG-interferon alfa-2b; Procedure: Conventional surgery; Procedure: Neoadjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Measured: 3 weeks following treatment

Secondary outcomes (1)

  1. Toxicity

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2006 (estimated)
  2. Study startFeb 2004
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00276523
Sponsor's protocol ID
CDR0000441020
Other IDs
MDA-ID-01450, ID01-450
Status last verified
Oct 2012
First submitted
12 Jan 2006
Last updated
31 Oct 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEG-interferon alfa-2b, Conventional surgery and Neoadjuvant therapy in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 3 weeks following treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00276523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012.

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