Name of the Trial
Phase II Study of Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody (MDX-010) in Patients with Locally Advanced or Metastatic (Stage IV) Pancreatic Adenocarcinoma (NCI-05-C-0141). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-05-C-0141.

Principal Investigator
Dr. Richard Royal, NCI Center for Cancer Research

Why This Trial Is Important
When foreign cells invade the body, the immune system mounts an immune response to the invading cells and kills them. The immune system is also capable of mounting a response to tumor cells. Often, however, the body's immune response isn't strong enough to completely destroy tumors.

During an immune response, cells signal each other in complex ways that serve to start, stop, or control the intensity of the response. Molecules found on many types of cancer cells stimulate certain immune system cells (called cytotoxic T lymphocytes, or activated T cells) to attack the cancer cells. Once the attack has started, however, the activated T cells produce a molecule called cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). This molecule then produces a signal that tells the T cells to stop their attack. This T-cell inhibition helps prevent normal cells from being harmed by an immune response, but it may also prevent the immune system from destroying malignant tumors. Researchers hope that blocking CTLA-4's inhibitory signal will lead to a more robust immune response against tumors.

In this trial, researchers are using a monoclonal antibody called MDX-010 to treat patients with advanced pancreatic cancer. MDX-010 binds to and blocks the activity of CTLA-4.

"We know that T lymphocytes infiltrate pancreatic tumors in great numbers, but the tumors present an immunosuppressive environment," said Dr. Royal. "We hope that MDX-010 will help lymphocytes overcome this immunosuppression and allow the patient's own immune system to destroy their cancer."

Who Can Join This Trial
Researchers will recruit up to 82 patients aged 18 or over with unresectable or metastatic (stage IV) pancreatic adenocarcinoma. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-05-C-0141.

Contact Information
The study is taking place at the NIH Clinical Center in Bethesda, Md. For more information about this trial, call the NCI Clinical Studies Support Center toll free at 1-888-NCI-1937. This call is confidential.