Status:
UNKNOWN
PANVAC™-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen
Lead Sponsor:
Therion Biologics Corporation
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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) ver...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00088660
Start Date
June 1 2004
Last Update
February 8 2006
Active Locations (62)
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1
University of South Alabama/ Cancer Research Institute
Mobile, Alabama, United States, 36693
2
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
3
Pacific Shores Medical Group
Long Beach, California, United States, 90813
4
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033