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

Condition(s) targeted: Head and Neck Cancer

Intervention: PEG-interferon alfa-2b (Drug); conventional surgery (Procedure); neoadjuvant therapy (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Roy S. Herbst, MD, PhD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

RATIONALE: 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.

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

Study design: Treatment, Randomized, Active Control

Primary outcome: Response rate

Secondary outcome:

Toxicity

Treatment modulation of biomarkers

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, VEGF, interleukin-8, bFGF, NFKB, 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

- ECOG performance status 0-2

- 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)

- 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 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

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

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: February 2004
Last updated: May 23, 2008