The Upper Michigan Brain Tumor Center has brought three clinical trials to Marquette General Hospital. Clinical trials give patients an opportunity to receive novel or experimental therapies or to contribute to the scientific knowledge regarding their tumor.
There are four types of clinical trials.
Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention trials : look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic trials : conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening trials : test the best way to detect certain diseases or health conditions.
Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness
The trials now available at MGH include one treatment trial, a diagnostic trial and a screening trial.
The treatment trial is entitled, “KARE 004: A PHASE II STUDY OF GLIADEL, CONCOMITANT TEMOZOLOMIDE AND RADIATION, FOLLOWED BY DOSE DENSE THERAPY WITH TEMOZOLOMIDE PLUS BEVACIZUMAB FOR NEWLY DIAGNOSED MALIGNANT HIGH GRADE GLIOMA.” This study is sponsored by the Kentuckiana Cancer Institute in Louisville, Kentucy. Renato V. LaRocca, M.D is the principle investigator for this national study while Richard A. Rovin, MD FACS and Suresh Nukala, MD are the principle investigators at MGH.
Briefly, this study is for patients with malignant gliomas at the time of the initial diagnosis. The current standard treatment at MGH is to undergo maximal, safe surgical resection (when possible). At the time of surgery, Gliadel wafers are placed into the cavity after resection. The Gliadel wafer is a biodegradable polymer disc that slowly releases chemotherapy called BCNU directly to the brain tissue surrounding the tumor cavity. About 2 weeks after surgery, the patients begin radiation therapy in combination with oral chemotherapy called temozolomide (Temodar). After radiation is completed, the patients continue to receive the temozolomide orally for five days of a 28 day cycle.
For patients participating in the KARE 004 study, there are some differences compared to the current standard therapy. Following completion of radiation treatments, instead of receiving the temozolomide for 5 days, patients will receive two 7-day courses of the temozolomide within each 28 day cycle. Every 14 days, they will also receive an intravenous infusion of a medication named bevacizumab. This will continue for up to 12 cycles.
Bevacizumab (or Avastin) is a monoclonal antibody that binds to and inactivates a protein called VEGF. VEGF stands for vascular endothelial growth factor. VEGF is a normal protein that is needed for blood vessel formation. As it turns out, in order to grow, tumors need to develop extra blood supply. Some tumors produce high levels of VEGF and so trick the body into building them new blood vessels. Bevacizumab is designed to prevent VEGF from bringing new blood vessels to the tumor. Without an adequate blood supply, the tumor can’t grow. Bevacizumab is already used in combination with other chemotherapy to treat colon cancers and is FDA approved for the treatment of recurrent malignant glioma.
This study will help determine if patients receiving more doses of temozolomide and bevacizumab have a better outcome than patients receiving the current standard therapy.
The second clinical trial is entitled, “TOTAL CANCER CARE” and it is sponsored by the Moffit Cancer Center in Tampa, Florida. This is not a treatment trial, rather it is a diagnostic trial. This is a study to evaluate genetic changes that occur in tumor tissue. In this study, a small sample of excess tumor tissue removed at the time of surgery or biopsy is frozen and shipped to Moffit Cancer Center. The scientists at Moffit can look at tens of thousands of different genes within the tumor at the same time. Once they have looked at tumors from many thousands of patients, they will be able to see patterns of gene expression. Once this information is known, it may be possible to design treatments that target the specific genetic changes identified. This is the first step towards personalized tumor therapy.
The third clinical trial is entitled, “IS VEGF A USEFUL SERUM BIOMARKER FOR PATIENTS DIAGNOSED WITH MENINGIOMA OR GLIOMA?” This study is sponsored by the UMBTC. Drs. Rovin and Nukala along with Dr. Robert Winn from Northern Michigan University are the lead investigators. This is a screening trial.
As described above, tumors need to recruit extra blood supply in order to grow. To get these extra blood vessels, tumors send out a signal—a protein called VEGF. This study looks at the level of VEGF in the bloodstream in patients diagnosed with a glioma or meningioma. The idea is that the level of VEGF in the bloodstream might be an indicator of tumor growth, or how a tumor is responding to treatment. Right now, an MRI is used to determine if a tumor is growing or responding to treatment. This study will correlate VEGF levels with tumor behavior as assessed by MRI. Someday it might be possible to use VEGF levels to monitor tumor behavior--certainly an easier and less expensive alternative to MRI.
If you or a family member is interested in learning more about the clinical trials or perhaps participating in a trial, call the UMBTC at 906-225-7739 to arrange for a consultation.