NCT00021424已完成1 期
Phase I/Pilot Study of Intralesional Immunotherapy With A Recombinant Avipox Virus Engineered To Express A Triad Of Co-Stimulatory Molecules In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck
National Institute on Deafness and Other Communication Disorders (NIDCD)2 个研究点 分布在 1 个国家开始时间: 2001年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV head and neck cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxic effects of recombinant fowlpox-TRICOM vaccine in patients with advanced squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases.
- Determine the safety profile of this regimen in these patients.
- Determine the clinical activity of this regimen, in terms of inflammation at injection site(s) and disease regression or stabilization, in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant fowlpox-TRICOM vaccine (rF-TRI) intralesionally once on weeks 0, 3, and 8. Beginning on week 16, patients may receive additional rF-TRI once every 8 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of rF-TRI until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 stage IV squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases for which current available treatment is not likely to offer a survival advantage or result in significant palliation
- •Unresectable locoregional recurrence after maximum radiotherapy OR
- •Local disease with unresectable distant metastases involving:
- •Base of skull
- •Prevertebral fascia
- •Deep neck muscles
- •Carotid artery (requiring resection)
- •Nasopharynx and/or pterygoid muscles
- •Ineligible to receive radiotherapy to head and neck during study
- •Primary intraoral lesions must be measurable and accessible to intralesional injections
- •No metastatic brain lesions, cerebral metastasis, or leptomeningeal disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •At least 2 months
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 8 g/dL
- •Bilirubin less than 1.5 mg/dL
- •AST/ALT less than 4 times upper limit of normal (ULN)
- •PT/PTT less than 1.5 times ULN
- •Creatinine less than 2.0 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No evidence of congestive heart failure
- •No serious cardiac dysrhythmia
- •No evidence of recent prior myocardial infarction on EKG
- •No clinical coronary artery disease
- •Neurologic:
- •No history of seizures or concurrent seizure disorder
- •No evidence of encephalitis, multiple sclerosis, or other structural brain lesion(s) by clinical or radiological evaluation
- •Immunologic:
- •No risk of immune system compromise
- •HIV negative
- •No hypersensitivity to eggs
- •No significant history of allergies (e.g., anaphylaxis or angioedema)
- •No active or chronic infection
- •No other serious concurrent medical illness
- •No other malignancy unless previously treated with curative intent and no evidence of persistent or recurrent disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy and recovered
- •Chemotherapy:
- 另有 11 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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