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A Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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GV-001.004 NCT00051467
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Trial Description
Summary The primary purpose of this study is to assess the safety and effectiveness of TNFerade™ Biologic when administered concurrently with 5-FU and radiation therapy as first-line treatment of unresectable locally advanced pancreatic cancer. TNFerade™ is a replication deficient adenovirus vector containing the gene for TNF-alpha controlled by a chemoradiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ Biologic is a novel way of selective delivery of TNF-alpha to tumor cells. TNFerade™ Biologic will be injected during five weekly injection sessions, concomitant with radiation and 5-FU. TNFerade™ Biologic will be administered by direct intratumoral injection using a percutaneous approach (PTA) or endoscopic ultrasound (EUS). Eligibility Criteria Inclusion Criteria - Patients with unresectable, locally advanced adenocarcinoma of the pancreas proven by biopsy or cytology (defined as direct extension to the SMA and/or celiac axis with absence of a fat plane between the low-density tumor and these arterial structures, or loss of patent superior mesenteric-portal vein confluence), who have not received previous treatment for pancreatic cancer. Patients who have been surgically explored and deemed unresectable on that basis are eligible, provided other entry criteria are met
- Karnofsky performance status = or >70%
- Life expectancy greater than 3 months
Exclusion Criteria - Metastatic (stage IV) disease (including involvement of the colon, adrenals, or kidney, or radiographic evidence of peritoneal seeding)
- Patients with ascites detected by CT, US or MRI
- Patients with bulky celiac adenopathy (i.e., > 2.5 cm)
- Diagnosis of islet cell tumor of the pancreas, lymphoma of the pancreas
- History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer or localized early stage prostate cancer
- Previous chemotherapy or radiation for pancreatic cancer or previous radiation to the target field
- Liver enzymes >3 x ULN (ALT, AST, total bilirubin, alkaline phosphatase)
- Coagulopathy (INR >1.5, PTT ratio >1.5)
- Renal insufficiency (serum creatinine >2.0 mg/dL)
- Significant anemia (e.g. hematocrit <28% or hemoglobin <9 g/dL) (may have RBC transfusion), or thrombocytopenia (platelet count <100,000/µL); or neutropenia (ANC <1500/µL)
- Patients with clinically significant pancreatitis within 12 weeks of treatment
- Contraindication to both percutaneous- and endoscopic- guided delivery
- Patients with history of deep venous thrombosis or pulmonary embolus
- Patients with doppler evidence of deep venous thrombosis at screening
- Patients with history of coagulopathy or known thrombophilic disorders
- Patients receiving hormone replacement therapy including oral contraceptives within 2 weeks prior to Day 1.
- Clinical evidence of active infection of any type, including hepatitis B or C virus
- Pregnant or lactating women. It is recommended that both men and women use condoms or another barrier method of birth control for at least 8 weeks following the last administration of TNFerade™ biologic and some form of birth control for at least 1 year
- Experimental medications within the last 4 weeks prior to Day 1
- Surgery within the last 4 weeks prior to Day 1 (if patient was ambulatory within 48 hours of surgery, patient may be considered eligible)
- Chronic systemic corticosteroid use at superphysiologic doses (greater than 10mg prednisone per day or equivalent)
- Significant concurrent medical or psychiatric illness which, in the opinion of the investigator, would interfere with the patient's ability to participate in the trial
Please note that there are additional entry criteria. The study center will determine if you meet all criteria. If you do qualify to participate, study personnel will explain the study and answer any questions you may have. You can decide whether or not you wish to participate but if you do not qualify for this trial, study staff will explain the reasons. Please contact your local center listed below, or call the toll free PACT study line for assistance at 1-888-344-6096
Trial Contact Information
Trial Lead Organizations/Sponsors GenVec Trial Sites
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U.S.A. |
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Alabama |
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Mobile |
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| | | | | | | | University of South Alabama Mitchell Cancer Institute |
| | Marion Long |
Ph: 251-445-8121 |
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Email:
long@usouthal.edu |
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Arizona |
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Scottsdale |
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| | | Mayo Clinic Scottsdale |
| | Ann Kolb |
Ph: 480-301-4927 |
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Email:
kolb.Ann@mayo.edu |
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Tucson |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | Arizona Cancer Center at University of Arizona Health Sciences Center |
| | Amy Kan, MS, CCRC |
Ph: 520-694-9065 |
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Email:
ykan@azcc.arizona.edu |
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California |
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Glendale |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Glendale Adventist Medical Center |
| | Maria Brown, MPH |
Ph: 818-409-6687 |
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Email:
brownmt@ah.org |
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La Jolla |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | Rebecca and John Moores UCSD Cancer Center |
| | Kalisha McIntosh |
Ph: 858-822-3798 |
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Email:
knmcintosh@ucsd.edu |
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Los Angeles |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | Jonsson Comprehensive Cancer Center at UCLA |
| | Nathalie Chorn |
Ph: 310-825-4493 |
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Email:
nchorn@mednet.ucla.edu |
| | USC/Norris Comprehensive Cancer Center and Hospital |
| | Susan Edwards |
Ph: 323-865-0936 |
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Email:
edwards_s@ccnt.usc.edu |
| | Heinz-Joseph Lenz, M.D. | Principal Investigator |
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Orange |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center |
| | Sentelle Eubanks |
Ph: 714-456-3860 |
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Email:
sentelle@uci.edu |
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San Francisco |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | San Francisco General Hospital Medical Center |
| | Sean Hashemi |
Ph: 415-206-4630 |
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Email:
HashemiS@sfghsurg.ucsf.edu |
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Colorado |
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Denver |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | University of Colorado Cancer Center at UC Health Sciences Center |
| | Maximiliano Smolkin |
Ph: 303-724-1872 |
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Email:
maximiliano.smolkin@uchsc.edu |
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District of Columbia |
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Washington |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center |
| | Lisa Ley |
Ph: 202-687-6653 |
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Email:
leyl@georgetown.edu |
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Florida |
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Tampa |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | H. Lee Moffitt Cancer Center and Research Institute at University of South Florida |
| | Tiffany Campos |
Ph: 813-745-8358 |
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Email:
Tiffany.campos@moffitt.org |
| | Tampa General Hospital |
| | Jennifer Cooper |
Ph: 813-844-4218 |
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Email:
jcooper@hsc.usf.edu |
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Georgia |
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Atlanta |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Winship Cancer Institute of Emory University |
| | Ira Blount |
Ph: 404-778-4449 |
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Email:
iblount@emory.edu |
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Illinois |
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Chicago |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | University of Chicago Cancer Research Center |
| | Sharone Kaplan |
Ph: 773-702-3712 |
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Email:
skaplan@surgery.bsd.uchicago.edu |
| | University of Illinois Cancer Center |
| | Sandee Bernklau, MSN, RN |
Ph: 312-413-0223 |
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Email:
sbern@uic.edu |
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Olympia Fields |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields |
| | Maureen McGlashan |
Ph: 708-747-4000 |
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Email:
maureen.mcglashan@ssfhs.org |
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Indiana |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
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Indianapolis |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Indiana University Medical Goup |
| | Kathleen McGreevy, RN |
Ph: 317-274-5392 |
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Email:
kmcgreev@iupui.edu |
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Kentucky |
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Lexington |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Lucille P. Markey Cancer Center at University of Kentucky |
| | Rebecca Shelton | |
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Email:
rshel1@email.uky.edu |
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Louisiana |
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Alexandria |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Christus St. Frances Cabrini Center for Cancer Care |
| | Tammy DeBona |
Ph: 318-448-6973 |
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Email:
tammy.debona@christushealth.org |
| | Steven Saccaro | Principal Investigator |
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Maryland |
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Baltimore |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| | Beth Griffith |
Ph: 410-502-9253 |
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Email:
bgriffit@jhmi.edu |
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Massachusetts |
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Boston |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Beth Israel Deaconess Medical Center |
| | Megan Healy |
Ph: 617-667-1943 |
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Email:
mehealy@bidmc.harvard.edu |
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Michigan |
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Detroit |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Barbara Ann Karmanos Cancer Institute |
| | Ann Marie Ferris, RN, BSN, CCRP |
Ph: 313-576-9373 |
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Email:
ferrisa@karmanos.org |
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Missouri |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
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Kansas City |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Research Medical Center |
| | Jennifer Otto |
Ph: 816-276-4227 |
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Email:
jennifer.otto@hcamidwest.com |
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St. Louis |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
| | Brandi Simmons |
Ph: 314-747-4112 |
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Email:
simmonsb@ccadmin.wustl.edu |
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Montana |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
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Billings |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Billings Clinic Cancer Center |
| | Joan Kock |
Ph: 406-238-2109 |
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Email:
JKoch@billingsclinic.org |
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New York |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
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New York |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Beth Israel Medical Center - Petrie Division |
| | Sherly Jacob-Perez |
Ph: 212-844-8292 |
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Email:
sjacob@chpnet.org |
| | Mount Sinai Medical Center |
| | Eugene Akahoho |
Ph: 212-824-7310 |
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Email:
eugene.akahoho@mssm.edu |
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North Carolina |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
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Greenville |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Leo W. Jenkins Cancer Center at ECU Medical School |
| | Denise Brigham, RN |
Ph: 252-744-5267 |
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Email:
brigham@ecu.edu |
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Ohio |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
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Cleveland |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Cleveland Clinic Taussig Cancer Center |
| | Shelley Robinson |
Ph: 216-444-9668 |
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Email:
robinss@ccf.org |
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Oregon |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
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Portland |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Legacy Clinical Research and Technology Centerr |
| | Aaron White |
Ph: 503-413-7202 |
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Email:
ajwhite@lhs.org |
| | Portland Providence Medical Center |
| | Katie Strauss |
Ph: 503-215-2619 |
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Email:
katie.strauss@providence.org |
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South Carolina |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
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Charleston |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Charleston Cancer Center |
| | Debi Craft, BS, RN, CCRC |
Ph: 843-576-1006 |
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Email:
debi.craft@charlestonCancer.com |
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Greenville |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | Cancer Centers of the Carolinas - Eastside |
| | Julie Martin, APRN, NP |
Ph: 864-679-3966 |
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Email:
julie.martin@usoncology.com |
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Texas |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
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Dallas |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Mary Crowley Medical Research Center at Sammons Cancer Center |
| | Jim Eamma |
Ph: 214-658-1945 |
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Email:
jeamma@mcmrc.com |
| | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas |
| | Dendra Vonmerveldt |
Ph: 214-648-5107 |
|
Email:
entra.vonmerveldt@utsouthwestern.edu |
|
|
Houston |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | Dan L. Duncan Cancer Center at Baylor College of Medicine |
| | Glenn Wilson |
Ph: 713-798-3468 |
|
Email:
ggwilson@bcm.tmc.edu |
|
Virginia |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
|
Richmond |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Virginia Commonwealth University Massey Cancer Center |
| | Diane Holdford, RN, BSN, CCRC |
Ph: 804-828-0296 |
|
Email:
djholdfo@hsc.vcu.edu |
|
Washington |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
|
Seattle |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center |
| | Jody C Mooney, MS |
Ph: 206-341-1452 |
|
Email:
jody.mooney@vmmc.org |
|
Wisconsin |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
|
Marshfield |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | | CCOP - Marshfield Clinic Research Foundation |
| | Charmaine Matti |
Ph: 715-387-5796 |
|
Email:
matti.charmaine@mcrf.mfldclin.edu |
|
|
Milwaukee |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |
| | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center |
| | Brenda Davies |
Ph: 414-805-4639 |
|
Email:
bdavies@mcw.edu |
|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00051467 Information obtained from ClinicalTrials.gov on December 15, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
![](https://webarchive.library.unt.edu/eot2008/20090115090946im_/http://www.cancer.gov/images/spacer.gif) |