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Trial record 1 of 1 for:    NCT00753220
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Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer (CRITICAL)

This study has been terminated.
(Withdrew the IND with the FDA.)
Sponsor:
Collaborators:
Prostate Institute of America
Community Memorial Hospital
HemaCare Corporation
Information provided by (Responsible Party):
Bostwick Laboratories
ClinicalTrials.gov Identifier:
NCT00753220
First received: September 12, 2008
Last updated: November 3, 2014
Last verified: November 2014
Results First Received: July 25, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Biological: VDC2008
Drug: Cyclophosphamide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Men at least 18 years of age diagnosed with prostate cancer with metastases limited to three sites (e.g., lymph nodes and/or bone) who have been determined to have undergone progression of their cancer under androgen blockade (i.e., are androgen-independent) will be eligible for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to any screening evaluations, the purpose of the study & study related tests/procedures will be explained, then subject signs ICF. Subject will undergo screening assessments to determine if he meets all of the inclusion criteria & none of the exclusion criteria. Screen failures will not be eligible for re-screening.

Reporting Groups
  Description
VDC2008

Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy

VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.

Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8


Participant Flow:   Overall Study
    VDC2008  
STARTED     7  
COMPLETED     2  
NOT COMPLETED     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
VDC2008

Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy

VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.

Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8


Baseline Measures
    VDC2008  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     5  
Age  
[units: years]
Mean ± Standard Deviation
  72  ± 10  
Gender  
[units: participants]
 
Female     0  
Male     7  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: Up to 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Duke K. Bahn
Organization: Prostate Institute of America
phone: 888-234-0004
e-mail: DKBahn@CMHhospital.org


No publications provided


Responsible Party: Bostwick Laboratories
ClinicalTrials.gov Identifier: NCT00753220     History of Changes
Other Study ID Numbers: CRITICAL001
Study First Received: September 12, 2008
Results First Received: July 25, 2013
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration