Clinical trial NCT00088660: PANVAC™-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: Metastatic
Lead sponsor: Therion Biologics Corporation
Sponsor class: INDUSTRY
First posted: 2004-08-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this multi-center, randomized, controlled trial are to evaluate the safety and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating factor (GM-CSF) versus best supportive care or palliative chemotherapy.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama/ Cancer Research Institute
state: Alabama
city: LaJolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: Chao Family Comprehensice Cancer Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc
state: California
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Aurora
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Greeley
country: United States
facility: Greeley Medical Clinic
state: Colorado
city: Loveland
country: United States
facility: Loveland Hematology Oncology
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Hospital/ Whittingham Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Cancer Center
state: District of Columbia
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Miami
country: United States
facility: VA Medical Center
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Sylvester Cancer Center
state: Florida
city: Boise
country: United States
facility: St. Luke's Mountain States Tumor Institute
state: Idaho
city: Coeur D Alene
country: United States
facility: North Idaho Cancer Center
state: Idaho
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: Oncology Associates
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Alexandria
country: United States
facility: Hematology Oncology Life Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Medical Oncology, LLC
state: Louisiana
city: Metairie
country: United States
facility: Jayne Gurtler, MD and Laura Brinz, MD APMC
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Cancer Center
state: Louisiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine and Blood Disorders
state: Maine
city: Baltimore
country: United States
facility: Franklin Square Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts-New England Medical Center, The Neeley Center for Clinical Research
state: Massachusetts
city: Detroit
country: United States
facility: Josephine Ford Cancer Center
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: St. Louis
country: United States
facility: Saint Louis University Cancer Center
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Great Falls
country: United States
facility: Great Falls Clinic, LLP
state: Montana
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Mineola
country: United States
facility: Winthrop Oncology/Hematology Division
state: New York
city: New York City
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Ohio
city: Kettering
country: United States
facility: Dayton Oncology Hematology
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Cancer Care
state: Texas
city: Houston
country: United States
facility: Dr. H. Alejandro Preti, F.A.C.P.
state: Texas
city: Houston
country: United States
facility: Elkins Pancreas Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Weatherford
country: United States
facility: Texas Cancer Care
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Milwaukee
country: United States
facility: Medical Consultants Ltd.
state: Wisconsin
Study officials:
References: