A Pilot Safety Study of Vaccination With Autologous, Lethally Irradiated Colorectal Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Patients Who Fail to Receive the First Six Scheduled Vaccinations Because of Toxicity
研究概览
简要总结
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.
详细描述
After you have given your consent to participate in this study, your study doctor will perform some tests to confirm that you are eligible to participate. These tests may take place up to 21 days before the surgery to remove a liver tumor, which will be used to create the vaccines. Many of the following examinations are commonly done to determine diagnosis and/or stage of disease and you may have already had some or all of these evaluations. They may or may not have to be repeated. These tests include a medical history, performance status, blod samples, routine blood tests, tumor assessment and blood pregnancy test (if applicable). If these tests indicate you are eligible for this study and you agree to participate, you will be referred to a surgeon for the surgical removal of tumor tissue from which the vaccine will be made.
The surgery will be performed at Massachusetts General Hospital. You will be asked to sign a separate consent form to give permission to the surgeon to perform this operation. That consent will describe the risks of the operation which involves removing the tumor cells from your liver.
After your surgery, there is a possibility that your physician will recommend other treatment before starting the vaccines if he or she feels it would be beneficial to your care and medically appropriate. This part of the treatment would not be experimental (for example, chemotherapy or radiation therapy).
Then, in this case, the vaccines made from your cancer will not be administered to you until at least 4 weeks after your last chemotherapy or radiation treatment. If the time between your operation and the first scheduled vaccine injection is 8 weeks or longer, we will ask you to undergo another chest, abdomen and pelvic CT scan and clinical blood work to confirm that it is still safe for you to proceed with the vaccines. After this 4 week rest period, vaccine administration will occur as previously outlined.
If these tests indicate you are eligible for this study and you agree to participate, you will be referred to a surgeon for the surgical removal of tumor tissue from which the vaccine will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Histologically documented hepatic colorectal cancer metastasis with resectable hepatic lesions
- •At least 4 weeks since last dose of chemotherapy, radiotherapy, immunotherapy, systemic glucocorticoid therapy or operation in order to receive vaccine
- •Fully recovered from hepatic resection
排除标准
- •Pregnant or breastfeeding
- •Uncontrolled active infection
- •Infection with HIV, Hepatitis B or C
- •Other current malignancies except in situ cancer or basal/squamous cell carcinoma
- •Active autoimmune disease
- •Hepatic metastases involving both branches of the portal vein or all three hepatic veins
- •Peritoneal metastases identified at the time of attempted resection
- •Greater than 1 month since resection of liver metastasis for vaccine production
结局指标
主要结局
Number of Patients Who Fail to Receive the First Six Scheduled Vaccinations Because of Toxicity
时间窗: 2 years
To determine the safety of 6 vaccinations with lethally irradiated, autologous colorectal cancer cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in stage IV colorectal cancer patients who are completely resected. Patient safety will be assured by monitoring the number of patients who fail to receive the first six scheduled vaccinations because of toxicity. If three or more patients experience grade 4 or worse toxicity due to the vaccine before completing six immunizations, the study will be terminated.
次要结局
- Progression Free Survival(75 months)
- Immune Response(2 years)
- Two Year Survival(2 years)
研究者
Cristina R. Ferrone, MD
Principal Investigator
Massachusetts General Hospital