Lung Cancer Vaccine: An Attack on Tumor Cells
by Mitchell Magee, M.D.

Lung cancer is one of the most common cancers in the U.S., representing about 13% of all cancers, and newly afflicting over 160,000 in 2001. Lung cancer accounts for over one-fourth (28%) of cancer deaths in the U.S., claiming more men and women than any other cancer. In fact, it kills more people than colon, prostate and breast cancer combined.

Anyone who has ever smoked has twice the risk of developing lung cancer as someone who has never smoked. However, about one out of five people diagnosed with lung cancer have never smoked.

Lung cancer is usually classified as either small cell or non-small cell. Non-small cell represents 75-80% of all cases of lung cancer and includes three distinct types of lung cancer: squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. These are grouped together and called "non-small cell lung cancer" (NSCLC) because their pattern of spread and their treatment differ from small cell lung cancer, and when diagnosed at an early stage, have the potential to be cured by surgery.

Unfortunately, most lung cancers are not diagnosed until they have grown large and spread to other parts of the lungs and/or body, making a surgical cure less likely or impossible. When the cancer has spread or metastasized, treatment may include chemotherapy or immunotherapy, which kills cancer cells throughout the body. Immunotherapy is a type of treatment for cancer that is based on the idea that the immune system can be activated to destroy cancer cells. Few studies of immunotherapy for advanced stage lung cancer have been published, but there is evidence to suggest the feasibility of producing a vaccine that can stimulate the immune system to specifically attack lung cancer cells.

Surgeons at CRSTI are currently conducting a clinical trial, in conjunction with U.S. Oncology and Cell Genesys Corporation, investigating one method of lung cancer vaccine preparation. The purpose of this study is to determine the safety and efficacy of administering this vaccine in advanced stage NSCLC patients.

Phase I/II Study of Vaccination With Irradiated Autologous Lung Tumor Cells Mixed With a GM-CSF Secreting Bystander Cell Line (Lung Bystander GVAX) in Advanced Stage Non Small Cell Lung Cancer (NSCLC):

This study tests a vaccine for the treatment of non-small cell lung cancer (NSCLC)and is open to patients who have advanced or recurrent NSCLC. The Lung Bystander GVAX® Vaccine consists of two parts: 1) a patient's tumor cells and 2) K562 Bystander GVAX® cells. In this study, a patient's own tumor will be used to try to make a cancer vaccine. Patients undergo a surgical procedure to obtain tumor tissue specifically for vaccine preparation. Their tumor cells are immediately preserved and stored for rapid processing into single cells and irradiated so they can no longer grow. In this form, they can be injected into the body, but they will not cause new cancer because they cannot grow. There is a 30% chance that preparation of the tumor cells for the vaccine will not be successful. If it is not successful, patients will not receive the vaccine. If the process is successful, patients will be asked to begin vaccine treatment approximately 4 weeks following the surgical tumor procurement.

The K562 Bystander GVAX® cells have been modified so they can secrete GM-CSF (Granulocyte Macrophage Colony Stimulating Factor). GM-CSF is a substance normally found in immune cells of the body in very small amounts. The K562 Bystander GVAX® cells have a circle of genetic material placed inside them that produce GM-CSF. It is believed that mixing a patient's tumor cells with the K562 Bystander GVAX® cells and injecting them under the skin will help activate the immune system to fight cancer. The goal of the vaccine is to create an army of white blood cells that can recognize and attack the tumor cells. The purpose of this research study is to find out what effects Lung Bystander GVAX® Vaccine has on patients and their lung cancer. This vaccine has not yet been approved by the Food and Drug Administration (FDA) for the treatment of NSCLC.

Preliminary results have been encouraging with some patients demonstrating significant immune response to tumor cells.

Dr. Mitchell Magee is a practicing cardiothoracic surgeon with COR Specialty Associates of North Texas, PA (CSANT) and Medical Director of CRSTI.