Clinical Trials (PDQ®) - National Cancer Institute

Page Options

Clinical Trial Questions?

Get Help:

	Quick Links


	Help Using the NCI Clinical Trials Search Form Educational Materials About Clinical Trials About NCI's Cancer Clinical Trials Registry Dictionary of Cancer Terms NCI Drug Dictionary

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Closed Over 18 Pharmaceutical / Industry TBC-PAN-003
NCT00088660

Trial Description

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.

Further Study Information

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 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Therion Biologics Corporation

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00088660
Information obtained from ClinicalTrials.gov on September 16, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.