Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Adva… (NCT00753220) | Clinical Trial Compass
TerminatedPhase 1/2
Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer
Stopped: Withdrew the IND with the FDA.
United States7 participantsStarted 2009-08
Plain-language summary
The purpose of this study is to determine if the intra-tumoral injection of a subject's own dendritic cells after cryotherapy of the prostate is a safe and effective treatment for advanced prostate cancer.
In theory, the injected dendritic cells will internalize antigens from the tumor cells which have been damaged by cryotherapy and activate the subject's immune system against that specific tumor.
Subjects will also receive a low dose chemotherapy designed to lower the number of T-regulatory cells which have been shown to lower or stop some immune system responses.
Hypothesis 1: Dendritic cell injection into cryotreated prostate cancer is non-toxic;
Hypothesis 2: Dendritic cell injection into cryotreated prostate cancer is medically beneficial to the subject.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Androgen Deprivation Therapy; or
✓. Organ-preserving therapy (i.e., non-prostatectomy) for primary prostate cancer (e.g., radiation therapy).
✓. TxNxM1a : Lymph node metastases histologically proven and confirmed by Central Pathology Laboratory;
✓. TxNxM1a: Lymph node metastases not histologically proven, given that the following are satisfied in the temporal order listed:
✓. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) for positive lymph nodes negative at original diagnosis of prostate cancer;
✓. Definitive local treatment undertaken;
✓. Evidence of local treatment failure on the basis of rising serum PSA;
✓. Prostatic biopsy positive for carcinoma;
Exclusion criteria
✕. A requirement for treatment with opioid analgesics for any reason within 21 days prior to study screening;
. Average weekly pain score of 4 or more as reported on the 11-point Pain Intensity - Numerical Rating Scale (Appendix III) over the two weeks prior to study enrollment.
✕. Systemic corticosteroids (use of inhaled, intranasal and topical steroids is acceptable);
✕. External beam radiation therapy or surgery;
✕. PC-SPES (or PC-SPEC) or Saw Palmetto extract;
✕. Megestrol acetate (Megace®), diethyl stilbesterol (DES), or cyproterone acetate;
✕. Ketoconazole;
✕. High dose calcitriol (i.e., \> 7.0 μg/week);