Updates in Cancer Clinical Trials
Between 200 and 250 clinical trials are available for patient enrollment at the Cancer Center with more than 700 patients participating each year. Some of our clinical trials are also conducted at community hospitals and regional cancer centers affiliated with the Carbone Cancer Center. Following are three clinical trials at the Carbone Cancer Center.
A new study entitled "A Pilot Trial of Hu14.18-IL2 (EMD 273063) and Cilengitide in Subjects with Completely Resectable Recurrent Stage III or Stage IV Melanoma" has recently opened at the Carbone Cancer Center. This study is for patients with advanced melanoma with recurrent regional (Stage III) metastasis or any distant (Stage IV) metastasis for whom surgical resection would be clinically recommended. While prolonged survival is a possibility for a minority of patients receiving surgery for recurrent Stage III or Stage IV disease, the majority of these patients will have subsequent disease recurrence and death due to melanoma. To date, no treatment has been proven superior to observation after surgery for these advanced melanoma patients. This new melanoma study plans to enroll up to 36 patients over the next 36 months and will evaluate evidence of anti-tumor activity of hu14.18 and cilengitide (alone or in combination) in previously untreated advanced melanoma patients who have achieved a complete response through surgical resection of all known metastatic disease. The use of this combined therapy for patients that have achieved a complete response following surgery is designed to reproduce the "microscopic residual disease" setting where this combination has been most effective in mice. Since detailed analyses are performed on the removed melanoma tissue, patients need to be enrolled in this study prior to the resection of metastatic disease to be eligible.
Patients with brain tumors either that spread from another area of the body or that originate in the brain frequently require the use of steroids to help control edema (swelling) in the brain. Brain edema contributes to patient symptoms such as headaches, nausea and vomiting, problems with speech, balance and seizures. Steroids, such as dexamethasone or prednisone, do a good job with helping to control edema, thus improving the above symptoms. Unfortunately, the long term use of steroids causes additional medical problems.
A recently opened study designed as a blinded, placebo-controlled trial is looking at a new drug, human Corticotropin Releasing Factor (hCRF) in comparison to standardly used steroids. The objective of this trial is to examine the safety and efficacy of hCRF in patients with malignant brain tumors who require the chronic use steroids to control signs and symptoms of edema around the brain tumor.
The standard treatment for advanced ovarian cancer is surgery followed by chemotherapy. Because ovarian cancer is highly sensitive to chemotherapy, most women will go into remission following initial treatment. However, more than 80 percent of these women will suffer a recurrence of their disease.
Researchers are looking to improve this statistic. One possible method is the use of maintenance (continued, low-dose) chemotherapy in patients who are clinically free of disease following surgery and chemotherapy.
The Carbone Cancer Center is currently participating in a national trial of maintenance chemotherapy in advanced ovarian cancer. Eligible patients are randomized to one of three treatment groups: chemotherapy with paclitaxel, chemotherapy with Xyotax™, or observation only. Paclitaxel is FDA-approved for use in ovarian cancer. Xytox™ is a modified form of paclitaxel that is administered over a shorter period of time and is associated with fewer allergic reactions than paclitaxel. In addition, Xyotax™ may cause less neurotoxicity and hair loss than paclitaxel. In this study, chemotherapy is given once per month for a total of 12 months. All participants are monitored monthly by a study physician and complete surveys assessing quality of life throughout the duration of the study.
Date Published: 03/14/2008