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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276523
• Other study ID #: CDR0000441020
• Secondary ID: MDA-ID-01450ID01
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2006
• Last updated: October 29, 2012
• Start date: February 2004
• Est. completion date: March 2006

Study information

• Verified date: October 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Other known NCT identifiers

• NCT00078416

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

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.
• Neoadjuvant therapy

Locations

Country	Name	City	State
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		3 weeks following treatment	No
Secondary	Toxicity		30 days	Yes

External Links

•   UT MD Anderson Cancer Center Official Website