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Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized 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.
 
ClinicalTrials.gov Identifier: NCT02137746
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
SOTIO Biotech ( SOTIO a.s. )

Study Description
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Brief Summary:
The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Dendritic Cells DCVAC/PCa Phase 2

Detailed Description:
Same as brief summary
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, One-arm, Multi-centre Phase II Clinical Trial Treated With Second Cycle of Active Cellular Immunotherapy With DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy Without Objective Progression
Actual Study Start Date : December 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : March 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: DCVAC/PCa Arm
Dendritic Cells DCVAC/PCa Experimental therapy
 Biological: Dendritic Cells DCVAC/PCa
DCVAC/PCa Experimental therapy


Outcome Measures
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Primary Outcome Measures :
  1. Safety evaluation of the second cycle of DCVAC [ Time Frame: 52 weeks ]
    Safety evaluation of the second cycle of active cellular immunotherapy, which includes a second leukapheresis procedure, who after primary radical prostatectomy completed first cycle of active cellular immunotherapy in clinical trial SP003 without objective disease progression requiring additional anti-tumor therapy.


Secondary Outcome Measures :
  1. Time to Prostate Specific Antigen (PSA) Doubling Time [ Time Frame: 52 weeks ]

Eligibility Criteria
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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

Inclusion Criteria:

  • Male 18 years and older
  • Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2)
  • Post radical Primary Prostatectomy
  • Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease

Exclusion Criteria:

  • Prior androgen deprivation therapy for prostate cancer
  • Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
  • Other uncontrolled intercurrent illness
  • Treatment with immunotherapy against PCa
  • Clinically significant cardiovascular disease
  • Active autoimmune disease requiring treatment
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): NCT02137746


Locations
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Czechia
Hradec Kralove, Czechia
Jablonec nad Nisou, Czechia
Novy Jicin, Czechia
Olomouc, Czechia
Prague 4, Czechia
Prague 5, Czechia
Uherske Hradiste, Czechia
Usti nad Labem, Czechia
Sponsors and Collaborators
SOTIO a.s.
Investigators
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Study Director: Tomas Scheiner, PhD SOTIO Biotech
More Information
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Responsible Party: SOTIO a.s.
ClinicalTrials.gov Identifier: NCT02137746    
Other Study ID Numbers: SP010
2013-003809-26 ( EudraCT Number )
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: June 2015
Keywords provided by SOTIO Biotech ( SOTIO a.s. ):
Prostate Cancer
Radical Prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases