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Trial of IV Injection of CV787 in Hormone Refractory Metastatic Prostate Cancer

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. Identifier: NCT00116155
Recruitment Status : Completed
First Posted : June 28, 2005
Last Update Posted : June 28, 2005
Information provided by:
Cell Genesys

Brief Summary:
This is a multi-center, open-label, dose finding study of CV787 adenovirus in patients with hormone refractory metastatic prostate cancer. Patients will receive treatment intravenously at one of up to nine dose levels, each containing three to six patients.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: CV787 (CG7870) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Dose Finding Trial of the Intravenous Injection of CV787, a Prostate-Specific Antigen Cytolytic Adenovirus, in Patients With Hormone Refractory Metastatic Prostate Cancer

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To determine the safety, tolerability, and the maximum tolerated dose of CG7870 when administered intravenously to patients with progressive metastatic hormone refractory prostate cancer

Secondary Outcome Measures :
  1. To evaluate prostate-specific antigen (PSA) response rates, duration of response, and time to disease progression
  2. To evaluate other clinical efficacy responses observed
  3. To evaluate the systemic pharmacokinetics of CG7870 after intravenous administration
  4. To monitor the immune response to CG7870

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Layout table for additonal information Identifier: NCT00116155    
Other Study ID Numbers: CV787-9902
First Posted: June 28, 2005    Key Record Dates
Last Update Posted: June 28, 2005
Last Verified: June 2005
Keywords provided by Cell Genesys:
Hormone Refractory Metastatic Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases