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PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00078585
First Posted: March 3, 2004
Last Update Posted: September 11, 2017
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.
Collaborators:
Therion Biologics Corporation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bavarian Nordic
March 1, 2004
March 3, 2004
September 11, 2017
November 2003
January 4, 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00078585 on ClinicalTrials.gov Archive Site
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PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
A Phase II Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC®-VF/TRICOM™ in Combination With GM-CSF in Patients With Androgen-Independent Adenocarcinoma of the Prostate

PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the immune system 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.

This multi-center, double-blind, randomized, empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer (AIPC).

All patients will be required to sign an informed consent prior to the performance of any on-study procedures. Patients will be screened for eligibility within 14 days prior to vaccine administration. 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 blinded treatment assignment. The ratio of active treatment to empty vector control (placebo) is 2:1.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Prostate Cancer
Biological: PROSTVAC®-VF/TRICOM™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2009
January 4, 2006   (Final data collection date for primary outcome measure)
  • Male patients > 18 years of age who have been vaccinated against smallpox;
  • Histological confirmation of adenocarcinoma of the prostate with evidence of metastatic disease including either of the following: Lymph node metastasis measurable by CT and/or Bone metastasis evaluable by bone scan;
  • Despite hormone therapy, there is evidence of two consecutive increases in PSA (Prostate Specific Antigen);
  • Gleason Score of 7 or lower at initial diagnosis.

Please note that there are additional eligibility criteria that you must meet to qualify.

If you do qualify to participate, study personnel will explain the trial in detail and answer any questions you may have. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00078585
TBC-PRO-002
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Not Provided
Bavarian Nordic
Bavarian Nordic
  • Therion Biologics Corporation
  • National Cancer Institute (NCI)
Study Director: Thomas J Schuetz, MD Therion Biologics Corporation
Principal Investigator: Philip W Kanthoff, MD Dana-Faber Cancer Institut
Bavarian Nordic
September 2017

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