Pilot Study of GVAX in Colorectal Cancer Cells

This study is a Pilot clinical trial. Pilot clinical trials test the safety of an investigational combination of drugs. Pilot studies provide information on what effects, both good and bad, the Investigational agent might have on your disease. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved the treatment for your type of cancer.
The main purposes of this study are to determine:
* The amount of vaccine that can be made for your colorectal tumor cells
* If the vaccine can be given safely
* What the effects of the vaccine are, both good and bad
* How the vaccine affects your immune system
* Whether this vaccine might have any effect on the return of your cancer in the liver after surgical removal
This study is being done because there are currently no treatments which have demonstrated to cure diseae which has progressed, or moved beyond the site of the primary site of disease (colon or rectum). These vaccinations will be given after you have completed the standard of care treatment as determined by your doctor.
Laboratory research has made vaccines from cancer cells by inserting genetic material from a protein called granulocyte-macrophage colony stimulating factor (GM-CSF) into the cancer cell. Once complete, the cancer cells are able to produce large amounts of GM-CSF. The vaccine made form these cells has a greater anti-tumor effect than cancer cells without GM-CSF. The purpose of this research study is to determine the safety of an investigational vaccine that will be made using your own colorectal cancer cells in the manner described above.
This vaccine has been used in several other research studies for treatment for other cancers (skin, lung, ovarian, sarcoma and leukemia.) Information from these other research studies suggests that this vaccine may help to reduce the risk of your colorectal cancer returning after you have your colorectal cancer surgery.
Due to these results in melanoma and several other tumors we are encouraged to use this vaccine approach in patients with liver metastases from colorectal cancer, after the cancer in the liver has been removed by surgery.

本研究为一项先导性临床试验（Pilot clinical trial）。先导性临床试验用于评估试验性联合用药的安全性。先导性研究可明确试验性干预制剂对受试者所患疾病的利弊效应。“试验性”意指该干预手段仍处于研究阶段，临床研究医师正进一步对其进行探索；同时也意味着美国食品药品监督管理局（Food and Drug Administration, FDA）尚未批准该疗法用于受试者所患的癌症类型。
本研究的主要目标为明确以下内容：
* 可针对受试者结直肠肿瘤细胞制备的疫苗剂量
* 该疫苗的给药安全性
* 该疫苗的利弊效应
* 该疫苗对受试者免疫系统的影响
* 该疫苗是否可对手术切除后肝内复发的结直肠癌产生干预作用
开展本研究的原因为，目前尚无获批疗法可治愈进展至原发灶（结肠或直肠）以外的结直肠癌。受试者需在完成主管医师确定的标准治疗方案后，接种该疫苗。
实验室研究通过将粒细胞-巨噬细胞集落刺激因子（granulocyte-macrophage colony stimulating factor, GM-CSF）的编码基因插入肿瘤细胞，制备肿瘤疫苗。经改造后的肿瘤细胞可大量表达GM-CSF，由此制备的疫苗较未插入该基因的肿瘤细胞疫苗具备更强的抗肿瘤活性。本研究旨在评估以上述方式利用受试者自身结直肠癌细胞制备的试验性疫苗的安全性。
该疫苗已在多项针对其他癌症（皮肤癌、肺癌、卵巢癌、肉瘤及白血病）的研究中应用。上述研究的数据表明，该疫苗或可降低结直肠癌患者术后的癌症复发风险。
鉴于黑色素瘤及其他多种肿瘤中的研究结果，我们计划在结直肠癌肝转移患者完成肝内肿瘤手术切除后，应用该疫苗疗法。