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 :
(Withdrew the IND with the FDA.)
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.
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.
Cryoablation of prostate followed b...
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