Vaccine Maintenance Treatment for Non-Small Cell Lung Cancer
To determine the response rate of the administration of HyperAcute-Lung Cancer Vaccine for subjects with stage IIIB or stage IV non-small cell lung cancer who have been treated with first line platinum-doublet therapy and have responded or are considered to have stable disease.
Carcinoma, Non-Small-Cell Lung
Biological: HyperAcute-Lung Cancer Vaccine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Tergenpumatucel-L (HyperAcute Lung) Cancer Vaccine in Subjects With Advanced Non-Small Cell Lung Cancer Who Responded to First Line Platinum-Doublet Treatment|
- To determine the response rate of the administration of HyperAcute® Lung (HAL) Cancer Vaccine cells by injection into subjects with stage IIIB (pleural effusion) or stage IV non-small cell lung carcinoma who have been treated with first line platinum-dou [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- To conduct correlative scientific studies of subject samples to determine the mechanism of any observed antitumor effect. In these studies human humoral and cellular immune responses to HAL cells will be evaluated. [ Time Frame: while on study ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||December 2014|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
|Experimental: Vaccine Group||
Biological: HyperAcute-Lung Cancer Vaccine
300 million cells given intradermally every 3 weeks for up to a total of 12 vaccinations
Other Name: HAL-1, HAL-2, HAL-3
Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most patients diagnosed with advanced stage lung cancer continue to die from their disease. Reasons for this include that: 1) patients are often diagnosed at a time when their lung cancer has already spread to other sites such as the chest cavity, bone, lung, liver, and brain limiting the options for local radiation therapy and surgery, and 2) the cancer cells are resistant or become resistant to chemotherapy drugs used to treat the patient. Resistance to one type of chemotherapy agent often rapidly leads to resistance against many other chemotherapy drugs.
These reasons are the major causes of cancer progression that are usually discussed when considering treatment options for patients with disease that continues to grow and spread. However, another important part of the body should be considered-- the immune system. Scientists have clearly shown that lung cancer cells produce a number of abnormal proteins or abnormal amounts of certain proteins found in normal lung cells. Normally one would expect a patient to develop an immune response against these abnormal proteins found in their cancer and attack them much the way we would fight off an infection from a foreign bacteria or virus. However, for reasons that scientists do not fully understand, the immune system fails to respond to these abnormal proteins and does not attack the lung cancer cells. This human clinical trial proposes a new way to make the immune system recognize the cancer and encourage it to attack the cancer cells.
Many people are familiar with the idea of transplants between people of organs like the kidneys or heart. When an organ transplant between two people is completed one of the problems that can occur is rejection of the donated organ by the recipient. This can occur because the immune system of the patient who receives the organ attacks the donated organ. If you were to attempt to transplant a pig heart to a human the rejection would be dramatically stronger than when organs are transplanted between two people. This is partly because lower animals express sugar-protein patterns on the surface of their cells that humans do not. In fact, our immune systems can quickly recognize tissues from lower mammals such as the pig or the mouse and destroys them.
In this project, we have put a mouse gene into human lung cancer cells that produces these abnormal sugar patterns and stimulates the immune system to attack the lung cancer. This strategy works well to kill human other cancer cells in the laboratory, but it needs to be tried in lung cancer patients to see if it will be effective and to determine if such a treatment causes any side effects. We propose to test this new treatment in subjects with non-small cell lung cancer to see if it can stop, slow or destroy tumors in these subjects. Subjects will be injected with an anti-tumor vaccine consisting of a mixture of three types of dead human lung cancer cells that have been genetically altered to express the mouse gene responsible for making this abnormal sugar-protein on the cells.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420732
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Missouri|
|Washington University in St. Louis|
|St. Louis, Missouri, United States, 63110|
|Study Chair:||Charles J. Link, Jr., M.D.||NewLink Genetics Corporation|