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

Sponsor:	Therion Biologics Corporation
Information provided by:	Therion Biologics Corporation
ClinicalTrials.gov Identifier:	NCT00088660

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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

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

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

Keywords provided by Therion Biologics Corporation:

Metastatic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010