A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Response rate
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
- •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
- +14 more not shown
Exclusion Criteria
- Not provided
Arms & Interventions
Control
Control (no treatment), conventional surgery.
Intervention: Neoadjuvant therapy (Procedure)
Control
Control (no treatment), conventional surgery.
Intervention: Conventional surgery (Procedure)
PEG-Intron 0.5 mg/kg
PEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.
Intervention: PEG-interferon alfa-2b (Biological)
PEG-Intron 0.5 mg/kg
PEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.
Intervention: Conventional surgery (Procedure)
PEG-Intron 0.5 mg/kg
PEG-interferon alfa-2b 0.5 mg/kg subcutaneously (SQ) once a week for 3 weeks, plus surgery.
Intervention: Neoadjuvant therapy (Procedure)
PEG-Intron 2.5 mg/kg
PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.
Intervention: PEG-interferon alfa-2b (Biological)
PEG-Intron 2.5 mg/kg
PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.
Intervention: Conventional surgery (Procedure)
PEG-Intron 2.5 mg/kg
PEG-interferon alfa-2b 2.5 mg/kg SQ once a week for 3 weeks, plus surgery.
Intervention: Neoadjuvant therapy (Procedure)
PEG-Intron 5.0 mg/kg
PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.
Intervention: PEG-interferon alfa-2b (Biological)
PEG-Intron 5.0 mg/kg
PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.
Intervention: Conventional surgery (Procedure)
PEG-Intron 5.0 mg/kg
PEG-interferon Alfa-2b 5 mg/kg SQ once a week for 3 weeks, plus surgery.
Intervention: Neoadjuvant therapy (Procedure)
Outcomes
Primary Outcomes
Response rate
Time Frame: 3 weeks following treatment
Secondary Outcomes
- Toxicity(30 days)