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A Phase III Randomized, Controlled Study to Evaluate the Safety and Efficacy of PANVAC™-VF in Combination With GM-CSF Versus Best Supportive Care or Palliative Chemotherapy in Patients With Metastatic (Stage IV) Adenocarcinoma of the Pancreas Who Have Failed a Gemcitabine-Containing Chemotherapy Regimen


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

A Phase III Randomized, Controlled Study to Evaluate the Safety and Efficacy of PANVAC™-VF in Combination With GM-CSF Versus Best Supportive Care or Palliative Chemotherapy in Patients With Metastatic (Stage IV) Adenocarcinoma of the Pancreas Who Have Failed a Gemcitabine-Containing Chemotherapy Regimen


PANVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the
body can be taught to fight cancer by directing the immune system to attack specific targets
found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This
trial will help determine if this vaccine can help fight cancer.

All patients will be required to sign an informed consent prior to the performance of any
study-related procedures. Patients will be screened for eligibility within 14 days prior to
their anticipated treatment start date (Day 0). Patients who meet all inclusion and
exclusion criteria will be centrally randomized into the study and will receive a unique
patient identification number and a treatment assignment. The ratio of active treatment to
control is 1:1 (PANVAC-VF: best supportive care or palliative chemotherapy).


Inclusion Criteria:



- Patients > 18 years of age who have been vaccinated against smallpox;

- Histologically confirmed diagnosis of adenocarcinoma of the pancreas;

- Patient has metastatic (Stage IV) disease;

- ECOG performance status 0-1;

- Failed a gemcitabine-containing chemotherapeutic regimen within 3 months of study
entry.

Exclusion Criteria:

- Prior or concurrent immunotherapy for cancer;

- Radiation therapy within 28 days prior to registration;

- Systemic corticosteroid therapy (except inhaled or topical steroids) within 28 days
of registration;

- Significant cardiovascular abnormalities or diseases;

- Known positive for HIV, hepatitis B and/or C;

- Evidence of immunodeficiency or immune suppression.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

TBC-PAN-003

NCT ID:

NCT00088660

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Metastatic
  • Pancreatic Neoplasms

Name

Location

USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Washington University School of Medicine Saint Louis, Missouri  63110
Temple University Cancer Center Philadelphia, Pennsylvania  19140
Swedish Cancer Institute Seattle, Washington  98104
North Idaho Cancer Center Coeur d'Alene, Idaho  83814
Arlington Cancer Center Arlington, Texas  76012
Jackson Memorial Hospital Miami, Florida  33136
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Maine Center for Cancer Medicine and Blood Disorders Scarborough, Maine  04074
Moores UCSD Cancer Center La Jolla, California  92093-0658
Carle Cancer Center Urbana, Illinois  61801
Tulane Cancer Center New Orleans, Louisiana  70112
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Pacific Shores Medical Group Long Beach, California  90813
Texas Cancer Care Fort Worth, Texas  76104
Mary Crowley Medical Research Center Dallas, Texas  75246
Tyler Cancer Center Tyler, Texas  75702
Medical Oncology, LLC Baton Rouge, Louisiana  70808
Cancer Care Northwest Spokane, Washington  99202
Duke University Medical Center Durham, North Carolina  27710
Scripps Cancer Center La Jolla, California  92037
Nebraska Methodist Hospital Omaha, Nebraska  68114
University of Colorado Health Science Center Aurora, Colorado  80010-0510
Charleston Cancer Center Charleston, South Carolina  29406
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
The Sarah Cannon Cancer Center Nashville, Tennessee  37203
Columbia Presbyterian Medical Center New York, New York  10032
University of Kentucky Lexington, Kentucky  40536-0098
Charleston Hematology Oncology Charleston, South Carolina  29403
Hematology Oncology Consultants, Inc. Columbus, Ohio  43235
Gabrail Cancer Center Canton, Ohio  44718
Virginia Cancer Institute Richmond, Virginia  23230
Oncology Associates Cedar Rapids, Iowa  52403
Josephine Ford Cancer Center Detroit, Michigan  48202
The Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Kansas City Cancer Center Kansas City, Missouri  64111
New York Oncology Hematology Albany, New York  12208
VA Medical Center Miami, Florida  33125
Dayton Oncology Hematology Kettering, Ohio  45067
VA San Diego Healthcare System San Diego, California  92161
University of South Alabama/ Cancer Research Institute Mobile, Alabama  36693
Chao Family Comprehensice Cancer Center Orange, California  92868
Desert Hematology Oncology Medical Group, Inc Rancho Mirage, California  92270
Greeley Medical Clinic Greeley, Colorado  80631
Loveland Hematology Oncology Loveland, Colorado  80538
Norwalk Hospital/ Whittingham Cancer Center Norwalk, Connecticut  06856
Lombardi Comprehensive Cancer Center Washington, District of Columbia  20007
Washington Hospital Cancer Center Washington, District of Columbia  20010
Jupiter Medical Center Jupiter, Florida  33458
Sylvester Cancer Center Miami, Florida  33136
St. Luke's Mountain States Tumor Institute Boise, Idaho  83712
Hematology Oncology Life Center Alexandria, Louisiana  71301
Jayne Gurtler, MD and Laura Brinz, MD APMC Metairie, Louisiana  70006
Franklin Square Hospital Baltimore, Maryland  21237
Tufts-New England Medical Center, The Neeley Center for Clinical Research Boston, Massachusetts  02111
Great Falls Clinic, LLP Great Falls, Montana  59405
Winthrop Oncology/Hematology Division Mineola, New York  11501
University of Oklahoma Health Science Center Oklahoma City, Oklahoma  73104
Dr. H. Alejandro Preti, F.A.C.P. Houston, Texas  77030
Elkins Pancreas Center Houston, Texas  77030
Medical Consultants Ltd. Milwaukee, Wisconsin  53215