Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells.

NCT00289341 | Completed Phase 1 Results

• 1 other identifier: RDA 0466
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and activity of a type of vaccine as immune therapy for prostate cancer. This vaccine will be made for each participant's own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells are immune cells, whose role is to identify foreign antigens (bacteria, viruses, or tumor cells, for example) in the body and to activate other cells of the immune system to mount an attack on that foreign antigen. Each participant will be randomized into either Arm 1 (experimental treatment only) or Arm 2 (placebo first, then the experimental treatment). Participants will be given the vaccine and three boosters as an injection. After the placebo phase, each participant in Arm 2 will crossover to the treatment phase so that all participants will eventually receive the experimental treatment.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Adverse Event

  Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks). At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine. All serious AEs and any other AEs that occurred 5 times or more are reported. The exact binomial test was used to compare the occurrence of each AE between groups.

  End of blinded phase (wk 9)

• Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The "Number" Indicated is the Median Difference of Post-Pre, of Each Antigen Group.

  The difference between post minus pre-vaccination bulk T cell proliferation was calculated for each antigen.

  pre- vs post-vaccination. Pre-vaccination T cells were collected at Wk 0 and post-vaccination T cells were collected at Wk 13

Secondary Outcomes (1)

• Change in PSA Slope, Pre- vs Post-vaccination.

  pre- vs post- vaccination PSA slopes.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

12 patients in the placebo Arm for 8 weeks followed by DC/LNCAP, DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks.

Biological: vaccine vehicle only

DC/LNCaP

EXPERIMENTAL

12 patients, receiving DC/LNCaP, DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks

Biological: DC/LNCaP

Interventions

vaccine vehicle only BIOLOGICAL

Subcutaneous injection of vaccine vehicle only (5% DMSO in normal saline), followed by cross-over to Arm 1 design.

Placebo

DC/LNCaP BIOLOGICAL

Subcutaneous injection of DC/LNCaP, DC/LNCaP-M1, DC/KLH

DC/LNCaP

Eligibility Criteria

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

You may qualify if:

• Disease Characteristics
• Histologically confirmed prostate carcinoma
• Progressive, disease required, i.e.: elevated PSA documented to be rising on 3 occasions, either despite castrate testosterone levels (below 50 ng/dl), or after definitive local therapy (prostatectomy or radiation).
• Prior/Concurrent Therapy
• Biologic therapy:
• Recovered from toxicity of any prior therapy
• Chemotherapy:
• At least 4 weeks since chemotherapy -Endocrine evaluation/therapy
• rising PSA values at least 2 weeks apart
• At least 2 weeks since concurrent corticosteroids (other than for replacement therapy for adrenal insufficiency)
• Medical hormonal therapy to maintain castrate testosterone levels permitted
• Radiotherapy:
• At least 4 weeks since radiotherapy
• Surgery:
• Prior surgery allowed

You may not qualify if:

• Disease Characteristics -No active CNS metastases
• Prior/Concurrent Therapy
• Biologic therapy:
• No prior autologous or allogeneic tumor vaccines
• No concurrent other immunotherapy
• Chemotherapy
• Not previously treated with more than 2 chemotherapy regimens
• No concurrent chemotherapy
• Radiotherapy --No concurrent radiotherapy
• Patient Characteristics -Cardiovascular: No NYHA class III/IV status No active angina, clinically significant cardiac arrythmia, recent (6 months) myocardial infarction
• Pulmonary:
• No severe debilitating pulmonary disease
• Other:
• No active infection requiring antibiotics
• No active pain requiring chronic opioid analgesics.

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

Related Publications (2)

• 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

• Frank MO, Kaufman J, Tian S, Suarez-Farinas M, Parveen S, Blachere NE, Morris MJ, Slovin S, Scher HI, Albert ML, Darnell RB. Harnessing naturally occurring tumor immunity: a clinical vaccine trial in prostate cancer. PLoS One. 2010 Sep 1;5(9):e12367. doi: 10.1371/journal.pone.0012367.

  PMID: 20824184 DERIVED

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
• 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: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 9, 2006
• Study Start: March 1, 2002
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 18, 2013
• Results First Posted: January 8, 2013

Record last verified: 2013-01

Locations

US (1)