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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 CenterLos Angeles, California  90033-0800
Washington University School of MedicineSaint Louis, Missouri  63110
Temple University Cancer CenterPhiladelphia, Pennsylvania  19140
Swedish Cancer InstituteSeattle, Washington  98104
North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
Arlington Cancer CenterArlington, Texas  76012
Jackson Memorial HospitalMiami, Florida  33136
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Maine Center for Cancer Medicine and Blood DisordersScarborough, Maine  04074
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Carle Cancer CenterUrbana, Illinois  61801
Tulane Cancer CenterNew Orleans, Louisiana  70112
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Pacific Shores Medical GroupLong Beach, California  90813
Texas Cancer CareFort Worth, Texas  76104
Mary Crowley Medical Research CenterDallas, Texas  75246
Tyler Cancer CenterTyler, Texas  75702
Medical Oncology, LLCBaton Rouge, Louisiana  70808
Cancer Care NorthwestSpokane, Washington  99202
Duke University Medical CenterDurham, North Carolina  27710
Scripps Cancer CenterLa Jolla, California  92037
Nebraska Methodist HospitalOmaha, Nebraska  68114
University of Colorado Health Science CenterAurora, Colorado  80010-0510
Charleston Cancer CenterCharleston, South Carolina  29406
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
The Sarah Cannon Cancer CenterNashville, Tennessee  37203
Columbia Presbyterian Medical CenterNew York, New York  10032
University of KentuckyLexington, Kentucky  40536-0098
Charleston Hematology OncologyCharleston, South Carolina  29403
Hematology Oncology Consultants, Inc.Columbus, Ohio  43235
Gabrail Cancer CenterCanton, Ohio  44718
Virginia Cancer InstituteRichmond, Virginia  23230
Oncology AssociatesCedar Rapids, Iowa  52403
Josephine Ford Cancer CenterDetroit, Michigan  48202
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Kansas City Cancer CenterKansas City, Missouri  64111
New York Oncology HematologyAlbany, New York  12208
VA Medical CenterMiami, Florida  33125
Dayton Oncology HematologyKettering, Ohio  45067
VA San Diego Healthcare SystemSan Diego, California  92161
University of South Alabama/ Cancer Research InstituteMobile, Alabama  36693
Chao Family Comprehensice Cancer CenterOrange, California  92868
Desert Hematology Oncology Medical Group, IncRancho Mirage, California  92270
Greeley Medical ClinicGreeley, Colorado  80631
Loveland Hematology OncologyLoveland, Colorado  80538
Norwalk Hospital/ Whittingham Cancer CenterNorwalk, Connecticut  06856
Lombardi Comprehensive Cancer CenterWashington, District of Columbia  20007
Washington Hospital Cancer CenterWashington, District of Columbia  20010
Jupiter Medical CenterJupiter, Florida  33458
Sylvester Cancer CenterMiami, Florida  33136
St. Luke's Mountain States Tumor InstituteBoise, Idaho  83712
Hematology Oncology Life CenterAlexandria, Louisiana  71301
Jayne Gurtler, MD and Laura Brinz, MD APMCMetairie, Louisiana  70006
Franklin Square HospitalBaltimore, Maryland  21237
Tufts-New England Medical Center, The Neeley Center for Clinical ResearchBoston, Massachusetts  02111
Great Falls Clinic, LLPGreat Falls, Montana  59405
Winthrop Oncology/Hematology DivisionMineola, New York  11501
University of Oklahoma Health Science CenterOklahoma City, Oklahoma  73104
Dr. H. Alejandro Preti, F.A.C.P.Houston, Texas  77030
Elkins Pancreas CenterHouston, Texas  77030
Medical Consultants Ltd.Milwaukee, Wisconsin  53215