NCT00345293CompletedPhase 1
A Phase I/II Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients.
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Rockefeller University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Toxicity
Study Overview
Brief Summary
The purpose of this study is to assess the safety and activity of DC/PC3, a dendritic cell vaccine used as immunotherapy for prostate cancer. The vaccine is made with each participants' own immune cells obtained through blood donation. Dendritic cells are known to activate other immune cells such as T cells, that are able to mount an attack against cancer cells. The dendritic cell vaccine will be administered as injections every 2 weeks over a course of 2 months.
Detailed Description
See Brief Summary.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Prostate cancer
- •Rising prostate specific antigen (PSA, 3 values, each measured at least 2 weeks apart) post initial therapy (ie, radiation, prostatectomy) human leukocyte antigen A2.1 (HLA-A2.1)
Exclusion Criteria
- •central nervous system metastasis
- •History of autoimmune disease
Outcomes
Primary Outcomes
Toxicity
Time Frame: through week 29
adverse events
Secondary Outcomes
- Clinical Response(Post treatment)
- Immunogenicity(pre and post treatment)
Investigators
Study Sites (1)
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