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

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.
 
ClinicalTrials.gov Identifier: NCT00078585
Recruitment Status : Completed
First Posted : March 3, 2004
Last Update Posted : September 11, 2017
Sponsor:
Collaborators:
Therion Biologics Corporation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bavarian Nordic

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: PROSTVAC®-VF/TRICOM™ Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2003
Actual Primary Completion Date : January 4, 2006
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078585


Locations
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Sponsors and Collaborators
Bavarian Nordic
Therion Biologics Corporation
National Cancer Institute (NCI)
Investigators
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Study Director: Thomas J Schuetz, MD Therion Biologics Corporation
Principal Investigator: Philip W Kanthoff, MD Dana-Faber Cancer Institut
More Information
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Publications of Results:

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Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00078585    
Obsolete Identifiers: NCT00081120
Other Study ID Numbers: TBC-PRO-002
First Posted: March 3, 2004    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases