PANVAC™-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00088660
• Other study ID #: TBC-PAN-003
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 30, 2004
• Last updated: February 7, 2006
• Start date: June 2004

Study information

• Verified date: February 2006
• Source: Therion Biologics Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• PANVAC™-VF

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Therion Biologics Corporation

Country where clinical trial is conducted

United States,