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

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PANVAC™-VF
Sponsored by
Therion Biologics Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South Alabama/ Cancer Research Institute
  • Moores UCSD Cancer Center
  • Pacific Shores Medical Group
  • USC/Norris Comprehensive Cancer Center
  • Chao Family Comprehensice Cancer Center
  • Desert Hematology Oncology Medical Group, Inc
  • Scripps Cancer Center
  • VA San Diego Healthcare System
  • University of Colorado Health Science Center
  • Greeley Medical Clinic
  • Loveland Hematology Oncology
  • Norwalk Hospital/ Whittingham Cancer Center
  • Lombardi Comprehensive Cancer Center
  • Washington Hospital Cancer Center
  • Jupiter Medical Center
  • VA Medical Center
  • Jackson Memorial Hospital
  • Sylvester Cancer Center
  • St. Luke's Mountain States Tumor Institute
  • North Idaho Cancer Center
  • Carle Cancer Center
  • Oncology Associates
  • University of Kentucky
  • Hematology Oncology Life Center
  • Medical Oncology, LLC
  • Jayne Gurtler, MD and Laura Brinz, MD APMC
  • Tulane Cancer Center
  • Maine Center for Cancer Medicine and Blood Disorders
  • Franklin Square Hospital
  • Tufts-New England Medical Center, The Neeley Center for Clinical Research
  • Josephine Ford Cancer Center
  • Kansas City Cancer Center
  • Saint Louis University Cancer Center
  • Washington University School of Medicine
  • Great Falls Clinic, LLP
  • Nebraska Methodist Hospital
  • Dartmouth Hitchcock Medical Center
  • The Cancer Institute of New Jersey
  • New York Oncology Hematology
  • Winthrop Oncology/Hematology Division
  • Columbia Presbyterian Medical Center
  • Duke University Medical Center
  • Gabrail Cancer Center
  • Hematology Oncology Consultants, Inc.
  • Dayton Oncology Hematology
  • University of Oklahoma Health Science Center
  • Temple University Cancer Center
  • Charleston Hematology Oncology
  • Charleston Cancer Center
  • Cancer Centers of the Carolinas
  • The Sarah Cannon Cancer Center
  • Arlington Cancer Center
  • Mary Crowley Medical Research Center
  • Texas Cancer Care
  • Dr. H. Alejandro Preti, F.A.C.P.
  • Elkins Pancreas Center
  • Tyler Cancer Center
  • Texas Cancer Care
  • Virginia Cancer Institute
  • Swedish Cancer Institute
  • Cancer Care Northwest
  • Medical Consultants Ltd.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 30, 2004
Last Updated
February 7, 2006
Sponsor
Therion Biologics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00088660
Brief Title
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

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Therion Biologics Corporation

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
PANVAC™-VF

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of South Alabama/ Cancer Research Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
Moores UCSD Cancer Center
City
LaJolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Chao Family Comprehensice Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Desert Hematology Oncology Medical Group, Inc
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Scripps Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
University of Colorado Health Science Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Greeley Medical Clinic
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Loveland Hematology Oncology
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Norwalk Hospital/ Whittingham Cancer Center
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Washington Hospital Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
VA Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
St. Luke's Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
North Idaho Cancer Center
City
Coeur D Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Oncology Associates
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Hematology Oncology Life Center
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Medical Oncology, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Jayne Gurtler, MD and Laura Brinz, MD APMC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Maine Center for Cancer Medicine and Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Franklin Square Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Tufts-New England Medical Center, The Neeley Center for Clinical Research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Josephine Ford Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Kansas City Cancer Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Louis University Cancer Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Great Falls Clinic, LLP
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
The Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
New York Oncology Hematology
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Winthrop Oncology/Hematology Division
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York City
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Hematology Oncology Consultants, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Dayton Oncology Hematology
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Temple University Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Charleston Hematology Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
The Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Cancer Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Dr. H. Alejandro Preti, F.A.C.P.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Elkins Pancreas Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texas Cancer Care
City
Weatherford
State/Province
Texas
ZIP/Postal Code
76086
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Medical Consultants Ltd.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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