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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)

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ClinicalTrials.gov Identifier: NCT00753220
Recruitment Status : Terminated (Withdrew the IND with the FDA.)
First Posted : September 16, 2008
Results First Posted : November 4, 2014
Last Update Posted : November 4, 2014
Sponsor:
Collaborators:
Prostate Institute of America
Community Memorial HealthCenter
HemaCare Corporation
Information provided by (Responsible Party):
Bostwick Laboratories

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Biological: VDC2008
Drug: Cyclophosphamide
Enrollment 7
Recruitment Details 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 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.
Arm/Group Title VDC2008
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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

Period Title: Overall Study
Started 7
Completed 2
Not Completed 5
Arm/Group Title VDC2008
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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

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  28.6%
>=65 years
5
  71.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
72  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
0
   0.0%
Male
7
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Maximum Tolerated Dose (MTD)
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PROTOCOL EXCERPT: The primary objective of the Phase I Portion of this study is the determination of the maximum tolerated dose (MTD) of intratumorally injected study agent VDC2008 administered following cryoablation of the prostate, and pre- and post-treatment with a low-dose cyclophosphamide therapy, as determined by toxicity and adverse event monitoring following treatment of metastatic androgen-independent prostate cancer.

ADDITIONAL INFORMATION: MTD was not reached by any study participant prior to end of the study. Additional participants would have been necessary to determine MTD.

Time Frame Up to 1 year
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title VDC2008
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: intratumorally delivered cells
NA [1] 
[1]
MTD was not reached by any study participant prior to end of the study.
Time Frame Overall Study (1 year, 2 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VDC2008
Hide Arm/Group Description

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

All-Cause Mortality
VDC2008
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
VDC2008
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VDC2008
Affected / at Risk (%) # Events
Total   3/7 (42.86%)    
Gastrointestinal disorders   
Heartburn  1 [1]  1/7 (14.29%)  1
General disorders   
Fatigue  1  1/7 (14.29%)  1
Pain  1  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Loss of Appetite  1  1/7 (14.29%)  1
Nervous system disorders   
Memory  1 [2]  1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Mild heartburn
[2]
Memory Problem from General Anesthesia
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
Responsible Party: Bostwick Laboratories
ClinicalTrials.gov Identifier: NCT00753220     History of Changes
Other Study ID Numbers: CRITICAL001
First Submitted: September 12, 2008
First Posted: September 16, 2008
Results First Submitted: July 25, 2013
Results First Posted: November 4, 2014
Last Update Posted: November 4, 2014