A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Presence or Absence of Germinal Centers in Resected Tissue
研究概览
简要总结
This trial studies how well high dose vitamin A compound works in treating participants with non-small cell lung cancer that can be removed by surgery. Vitamin A compound may increase the number of germinal centers (immune centers that make antibodies mature) in tumor and lymph tissues which may be beneficial to patients with cancer.
详细描述
PRIMARY OBJECTIVES:
I. To compare the percentage of resected cancers containing germinal centers (GCs) in patients who receive neoadjuvant vitamin A compound (vitamin A) to controls.
SECONDARY OBJECTIVES:
I. To compare the abundance of GCs in adjacent lymph nodes in patients who receive neoadjuvant vitamin A to controls.
II. To compare histopathologic responses based on tumor necrosis in lung cancer patients who receive neoadjuvant vitamin A to controls.
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
- None
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
- •Patient must be 18 years of age or older.
- •Patients must have either biopsy proven or radiographically suspected non-small cell lung cancer.
- •Patients must have disease in the chest that is felt to be surgically resectable.
- •ECOG performance status of 0-
- •Ability to understand and the willingness to sign an IRB-approved informed consent document
排除标准
- •Patients younger than 18 years of age
- •Women who are pregnant or breast feeding.
- •Patients may not be receiving any other investigational agents for the treatment of nonsmall cell lung cancer.
- •Patients may not be taking the following medications: high dose vitamin A supplement (multivitamin supplements prohibited only if vitamin A content is greater than 3,500 international units), bexarotene, alitretinoin, tretinoin, adapalene, isotretinoin, acitretin, doxycycline, minocycline, or demeclocycline,
- •Uncontrolled intercurrent illness including, but not limited to, pancreatitis, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Hypervitaminosis A - toxic effects of ingesting too much vitamin A.
研究组 & 干预措施
Therapeutic Conventional Surgery
Description Participants undergo surgical resection.
干预措施: Therapeutic Conventional Surgery (Procedure)
Vitamin A compound
Participants receive vitamin A compound PO for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection.
干预措施: Vitamin A Compound (Drug)
结局指标
主要结局
Presence or Absence of Germinal Centers in Resected Tissue
时间窗: Up to 2 years
Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.
次要结局
- Presence or Absence of Tumor Necrosis(Up to 2 years)
- Overall Survival(Up to 2 years)
- Proportion of Germinal Centers in Lymph Nodes(Up to 2 years)