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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Therion Biologics Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Therion Biologics Corporation
ClinicalTrials.gov Identifier:
NCT00088660
First received: July 30, 2004
Last updated: February 7, 2006
Last verified: February 2006
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Biological: PANVAC™-VF
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Therion Biologics Corporation:

Estimated Enrollment: 250
Study Start Date: June 2004
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088660

  Show 62 Study Locations
Sponsors and Collaborators
Therion Biologics Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00088660     History of Changes
Other Study ID Numbers: TBC-PAN-003
Study First Received: July 30, 2004
Last Updated: February 7, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Therion Biologics Corporation:
Metastatic

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 31, 2014