| Ad Title: |
A Phase 2, Multicenter, Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL Wafer in Patients with Metastatic Brain Cancer |
| Study Title: |
A Phase 2, Multicenter, Exploratory Study Evaluating the Treatment Effect of Surgery Plus GLIADEL Wafer in patients with Metastatic Brain Cancer |
| Protocol Number: |
122007-028 |
| Department(s) involved in the Study: |
Int Med - Hematology, Neurology
|
| Purpose of the Study: |
To evaluate the effect of the surgical intervention and insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic brain cancer. |
| Participant Eligibility: |
Eligible participants must be age 18 and older with a primary diagnosis of solid-based tumor cancer or unknown primary cancer and have 1-3 brain metastatis(es) for which surgical resection is planned for a single metastasis and any remaining metastases are planned for SRS or an intra-operative diagnosis of metastatic brain tumor in a patient with a single brain lesion. In addition, participants must also have a life expectancy of 12 weeks or greater, a Karnofsky Performance Status of 70 or higher, and an RPA status of 1 or 2. Participants must sign the informed consent, agree to use a barrier method of contraception, and comply with all study requirements. |
| Disease/Condition Under Study: |
metastatic brain tumors |
| Cancer Related Study: |
Yes
|
| Study Drug(s): |
|
| Study Device(s): |
Gliadel Wafer
|
| Study Doctor: |
Dr. Elizabeth Maher |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
Parkland Memorial Hospital
|
Yes
|
|
UT Southwestern University Hospitals Zale Lipshy Building
|
Yes
|
|
UT Southwestern Medical Center
|
Yes
|
|
| Contact Phone: |
214-648-7031 |
| Email: |
stacy.foster@utsouthwestern.edu |
| Other Information: |
Please contact study coordinator for additional information. |
| Website Keywords: |
Brain Cancer, Neurology
|
| Medical Keywords: |
brain tumors, Gliadel Wafer
|
