NCT00019929已完成2 期
Phase II Trial of Individualized Mutant p53 Peptide-Pulsed Cultured Autologous Dendritic Cells in the Adjuvant Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer After Standard Therapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Overall survival by CTEP CTC v2.x
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying vaccine therapy given after standard therapy to see how well it works in treating patients with stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the overall survival in patients with locally advanced non-small cell lung cancer immunized with adjuvant mutant p53 peptide-pulsed autologous dendritic cells after standard therapy.
- Assess the safety and immunological efficacy of this regimen in terms of inducing or boosting a mutant p53-specific immune response in this patient population.
OUTLINE: Patients undergo p53 gene mutation analysis. Patients without a suitable gene mutation receive no vaccination. Patients with a suitable p53 gene mutation receive mutant p53 peptide-pulsed autologous dendritic cells IV over 1-2 minutes weekly for 5 weeks. Patients achieving an immune response with no evidence of progressive disease may receive additional vaccinations every 2 months for a maximum of 10 immunizations.
Patients are followed for 5 years.
PROJECTED ACCRUAL: Approximately 120 patients (40 on the vaccination arm) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC) with one of the following p53 mutations:
- •Point mutation altering the protein sequence
- •Frame-shift mutation with the generation of a novel sequence
- •No significant pleural effusions visible on plain chest radiography
- •Must have completed or plan to undergo curative intent therapy for NSCLC
- •At least 2 courses of neoadjuvant chemotherapy for patients with known N2 or N3 resectable disease OR
- •At least 55 Gy radiotherapy with concurrent or sequential chemotherapy for patients with unresectable disease
- •Patients with incidental N2 or N3 disease at time of surgery may receive optional adjuvant chemotherapy and radiotherapy
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Lymphocyte count greater than 475/mm^3
- •Granulocyte count greater than 1,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 2.0 mg/dL
- •SGOT less than 3 times normal
- •Albumin at least 3.0 g/dL
- •No signs of acute hepatitis B infection
- •Hepatitis B surface antigen positive allowed provided there are no signs of chronic active hepatitis
- •No prior hepatitis C infection
- •Creatinine less than 2.5 mg/dL
- •Calcium less than 11.0 mg/dL (corrected for albumin)
- •Cardiovascular:
- •No myocardial infarction or significant ventricular arrhythmias within the past 6 months
- •No other malignancy within the past 5 years unless curatively treated and probability of recurrence is less than 5%
- •HIV negative
- •No psychiatric or other condition that would preclude study
- •No serious ongoing infection
- •No other serious medical condition that would limit life expectancy to less than 2 years
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy and no anticipated need for chemotherapy for at least 2 months after vaccinations
- •Endocrine therapy:
- •At least 4 weeks since prior supraphysiologic steroids and no anticipated need for steroid therapy for at least 2 months after vaccinations
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy and no anticipated need for radiotherapy for at least 2 months after vaccinations
- •See Disease Characteristics
- •No influenza vaccination if egg allergy present
- •At least 4 weeks and no greater than 24 weeks since completion of all prior modalities for primary therapy
排除标准
- 未提供
结局指标
主要结局
Overall survival by CTEP CTC v2.x
Toxicity by CTEP CTC v2.x
Disease-free survival by CTEP CTC v2.x
次要结局
- Immunological response by ELISPOT before and 2 weeks after last vaccine
研究者
研究点 (2)
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