Wednesday, February 10, 2010

New Clinical Research Project Now Enrolling Patients

The UMBTC is beginning another clinical research study at MGH.

The study is entitled, "Is the presences of cytomegalovirus (CMV) in tumor tissue a prognostic factor for patients with newly diagnosed glioblastoma multiforme (GBM)?"

Background: CMV is a member of the herpesvirus family. Other members of this family include the viruses that cause chicken pox and mononucleosis. Between 50% and 80% of adults in the United States are infected with CMV by age 40. Most CMV infections are silent, causing no symptoms.  CMV infection can be serious, especially when transmitted to an infant at birth or in a patient immunosuppressed because of medication (i.e. transplant patients) or HIV. Once CMV is in our body, it stays there, dormant, for life.  Currently, there is no treatment for CMV.

Is there a link between CMV and GBM?  In 2002, Charles Cobbs, a Neurosurgeon, first reported finding CMV DNA in GBM tumor samples.  This result was confirmed by other investigators, including Duane Mitchell at Duke University.

It is unlikely that CMV causes GBM. But because CMV related proteins have an effect on cell growth and survival, CMV may contribute to the aggressive behavior of GBM. For example, CMV might make tumor cells more resistant to chemotherapy and radiation therapy or it might help tumor cells evade the immune system.

Study objectives: 
1. Quantify the amount of CMV DNA that is present in tumor tissue. We plan to develop a test that will tell us how much, if any, CMV DNA is present in a specimen of tumor tissue. We will use a technique called real time polymerase chain reaction (PCR). For this test, DNA will be extracted from a  small amount of tumor tissue removed at the time of surgery.  
2. We will next determine if the presence of CMV DNA in GBM samples is an independent prognostic factor. That is, does a person whose tumor contains CMV DNA respond better or worse to treatment? We will also use statistical tests to determine if a particular level of CMV DNA can predict response to treatment.
3. If the results look promising, we hope to expand the study to include other brain tumor centers and pediatric patients.
4. If it turns out that CMV DNA has a negative impact on patients, new and specific treatments can be developed to target CMV.

This study has been approved by the Institutional Review Board at MGH and the HIPAA compliance officer at MGH. That means that this study meets federal guidelines to protect a patient from harm and to protect confidential medical information.

If you or your family have questions about this clinical research, please contact the UMBTC at 906-225-7739 or email us at info@hopestartshere.org.


No comments: