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

NCT00345293 | Completed Phase 1 Results DMC

• 1 other identifier: RDA-0537
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity

  adverse events

  through week 29

Secondary Outcomes (2)

• Immunogenicity

  pre and post treatment

• Clinical Response

  Post treatment

Study Arms (1)

DC/PC3 vaccine

EXPERIMENTAL

3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)

Biological: autologous dendritic cell vaccine (DC/PC3)

Interventions

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

DC/PC3 vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• central nervous system metastasis
• History of autoimmune disease

Sponsors & Collaborators

• Rockefeller University: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10065, United States

Location

Related Publications (1)

• Frank MO, Kaufman J, Parveen S, Blachere NE, Orange DE, Darnell RB. Dendritic cell vaccines containing lymphocytes produce improved immunogenicity in patients with cancer. J Transl Med. 2014 Dec 5;12:338. doi: 10.1186/s12967-014-0338-3.

  PMID: 25475068 DERIVED

Related Links

• study description at Rockefeller University website

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Mayu Frank, MS, ANP, Clinical Research Nurse Practitioner
• Organization: Rockefeller University

frankm@rockefeller.edu

212-327-7443

Study Officials

• Robert B Darnell, MD PHD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2006
• First Posted: June 28, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2015
• Last Updated: April 18, 2016
• Results First Posted: April 18, 2016

Record last verified: 2016-04

Locations

US (1)