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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088660
Recruitment Status : Unknown
Verified February 2006 by Therion Biologics Corporation.
Recruitment status was:  Active, not recruiting
First Posted : August 2, 2004
Last Update Posted : February 8, 2006
Information provided by:
Therion Biologics Corporation

July 30, 2004
August 2, 2004
February 8, 2006
June 2004
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Complete list of historical versions of study NCT00088660 on Archive Site
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PANVAC™-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen
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
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.

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).

Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
Biological: PANVAC™-VF
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Therion Biologics Corporation
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Therion Biologics Corporation
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP