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Completed

NCT Number: NCT00345293

Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rockefeller University Hospital

New York, 10065, United States

About this study

See Brief Summary.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous dendritic cell vaccine (DC/PC3)

Biological

ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity

Primary outcomes

  1. Toxicity

    Time frame: through week 29

    adverse events

Secondary outcomes

  1. Immunogenicity

    Time frame: pre and post treatment

    The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts).

  2. Clinical Response

    Time frame: Post treatment

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Collaborators

  • Memorial Sloan Kettering Cancer Center

Registry information

Official study title

A Phase I/II Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients.

Important dates

Study start
2006
Primary completion
2013
Study completion
2015
First posted
Jun 28, 2006
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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