Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning - Full Text View

Sponsor:	Roger Williams Medical Center
Information provided by (Responsible Party):	Roger Williams Medical Center
ClinicalTrials.gov Identifier:	NCT00664196

Purpose

This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells (designer T cells) in hormone refractory prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Biological: Gene Modified T Cells	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Roger Williams Medical Center:

Primary Outcome Measures:

Determine the safety of using modified T cells by documenting the type and severity of any side effects and establishing the Maximum Tolerated Dose (MTD) [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tumor Response [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
Pharmacokinetics [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
Pharmacodynamics [ Time Frame: 1 Month ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Biological: Gene Modified T Cells One time infusion Modified T-Cells given through a vein in the arm or a catheter over a 30-60 minute period. Other Names: Designer T-Cells PSMA Hormone Refractory

Detailed Description:

The study creates autologous gene-modified T cells against prostate specific membrane antigen (PSMA, unrelated to PSA) (designer T cells) by ex vivo modification of patient T cells. T cells are collected by phlebotomy or leukopheresis, transported to the RWMC cGMP Cell Manipulation Core and transduced with retrovirus containing a chimeric immune receptor (CIR) that is expressed on the modified cells. This CIR links specificity of an antibody against PSMA with signaling domains of the T cell and redirects the recognition of the T cells to engage and kill prostate cancer cells anywhere in the body. These are administered in a dose escalation of 10^9 to 10^11 cells following non-myeloablative (NMA) conditioning. This conditioning creates a "space" in the blood and marrow for engraftment of the infused cells to maintain of high level of anti-tumor effector T cells in the body. Each patient is treated with a single dose of T cells, without repeat dosing. Patients are followed for toxicity and response and pharmacokinetics-pharmacodynamics of the infused T cells. Patients are on-study for one-month after their T cell dose.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of prostate cancer
Elevated PSA
Life expectancy > 4 months
Performance status 0-1
ANC 1.0
Platelets > 100,000
Hemoglobin > 8.0
Creatinine < 1.5mg/dl
Direct Bilirubin < 1.5 mg/dl
No evidence of CHF, CAD, cardiac arrhythmias, A-fib, A flutter, myocardial infarction.
No serious, symptomatic obstructive or emphysematous lung disease
No asthma requiring IV medication during last 12 months, no serious lung disease associated with dyspnea at normal activity levels, or at rest due to any cause, including cancer metastasis and pleural effusion
Patients must have a biopsy able tumor, and be willing to undergo biopsy (Group 3 only)
Patient is at least 18 years of age.

Exclusion Criteria:

Serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic or allergic disease based on history, labs or physical exam
Active clinical disease caused by CMV, Hepatitis B, or C, HIV, TB
Cytotoxic and/or radiation therapy during last 4 weeks prior to entry
Any concurrent malignancies
Patient requires systemic steroids
Patient has participated in prior investigational therapy
Patient has prior exposure to mouse antibody
Patient has had irradiation to whole pelvis or >25% marrow

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664196

Contacts

Contact: Robin A Davies, BA, BSN, RN

401-456-2268

rdavies@rwmc.org

Locations

United States, Rhode Island
Roger Williams Medical Center	Recruiting
Providence, Rhode Island, United States, 02908
Contact: Robin A Davies, BA, BSN, RN 401-456-2268 rdavies@rwmc.org
Principal Investigator: Richard P Junghans, PhD, MD

Sponsors and Collaborators

Roger Williams Medical Center

Investigators

Principal Investigator:

Richard P Junghans, PhD, MD

Roger Williams Hospital

More Information

No publications provided

Responsible Party:	Roger Williams Medical Center
ClinicalTrials.gov Identifier:	NCT00664196 History of Changes
Other Study ID Numbers:	595-04, W81XWH-05-1-0408
Study First Received:	April 17, 2008
Last Updated:	January 18, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roger Williams Medical Center:

Prostate Cancer
T cells
Gene Transfer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012