NCT00006470已完成2 期
Phase II Study of Postoperative Adjuvant Immunotherapy and Radiation in Patients With Completely Resected Stage II and Stage IIIA Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 237
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these two treatments may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with radiation therapy in treating patients who have stage II or stage IIIA non-small cell lung cancer that has been completely removed in surgery.
详细描述
OBJECTIVES:
- Determine the humoral and T-cell response to adjuvant monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine with radiotherapy in patients with completely resected stage II or IIIA non-small cell lung cancer.
- Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine intracutaneously in separate sites once weekly for 3 weeks beginning 2-7 weeks (no later than 49 days) after surgery and then subcutaneously once monthly for 2 years regardless of disease progression. Beginning no more than 1 week after the third postoperative vaccination, all patients undergo radiotherapy 5 days a week for 5-6 weeks. Patients with extracapsular nodal metastases or T3 lesions also undergo 6 additional radiotherapy boosts.
Patients are followed at 4-6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
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 II or IIIA non-small cell lung cancer
- •T1-3, N1-2, M0
- •No stage IIIB (e.g., contralateral N3), stage IV (M1), or T3, N0, M0 disease
- •N1 disease eligible only if hilar lymph node involvement present
- •No bronchoalveolar carcinoma with lobar or multilobar involvement
- •No small cell lung carcinoma, including mixed histology
- •No more than 7 weeks since prior surgery (lobectomy, sleeve resection, bilobectomy, or pneumonectomy)
- •Negative surgical margins
- •No incompletely resected gross disease OR
- •No microscopically positive bronchial or vascular margins
- •No known CNS metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Zubrod 0-1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Not specified
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No superior vena cava syndrome
- •FEV_1 at least 1.0 L
- •Gastrointestinal:
- •No prior celiac disease, familial polyposis, Turcot's syndrome, Gardner's syndrome, Peutz-Jegher's syndrome, or hereditary non-polyposis colon cancer
- •No prior colitis, inflammatory bowel disease, or pancreatitis within the past 10 years
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known sensitivity to rodent proteins
- •No prior hypersensitivity or contraindication to study treatments (e.g., monoclonal antibody 11D10 anti-idiotype vaccine, monoclonal antibody 3H1 anti-idiotype vaccine, aluminum hydroxide, or murine proteins) or any excipients
- •No prior clinically significant hypersensitivity reactions (e.g., angioedema, anaphylaxis, or serious dermatological manifestations) or asthmatic attacks requiring hospitalization
- •No prior immune or immunodeficiency disorders (e.g., HIV, sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders)
- •No prior seizure disorder requiring continuous medication
- •No active infection
- •No other prior or concurrent malignancy within the past 3 years except surgically treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer
- •No medical contraindication to surgery, radiotherapy, or immunotherapy
- •No prior drug or alcohol abuse (excluding nicotine) within the past 12 months
- •No prior psychiatric or addictive disorder that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior murine antibodies (e.g., OncoScint scan)
- •No prior monoclonal antibody 11D10 anti-idiotype vaccine, monoclonal antibody 3H1 anti-idiotype vaccine, or other investigational carcinoembryonic antigen-derived therapy
- •At least 3 years since other prior immunotherapy
- •At least 30 days since prior immunization (e.g., influenza)
- •No immunomodulatory therapy (e.g., gold, auranofin, hydroxychloroquine, sulfasalazine, penicillamine, levamisole, dapsone, azathioprine, intravenous immunoglobulin, leukotriene antagonists, cromoglycate, ketotifen, nedocromil, psoralin-ultraviolet-light, or plasmapheresis) within 30 prior to the first dose of study drug or 5 half-lives of the action of the agent, whichever is longer
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排除标准
- 未提供
研究者
研究点 (237)
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