A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- 另有 14 项未显示
排除标准
- 未提供
研究组 & 干预措施
Control
Control (no treatment), conventional surgery.
干预措施: Neoadjuvant therapy (Procedure)
Control
Control (no treatment), conventional surgery.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Neoadjuvant therapy (Procedure)
结局指标
主要结局
Response rate
时间窗: 3 weeks following treatment
次要结局
- Toxicity(30 days)