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

NCT00664196 | Suspended Phase 1 DMC

• 2 other identifiers: 595-04W81XWH-05-1-0408
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer; T cells; Gene Transfer

Outcome Measures

Primary Outcomes (1)

• 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)

  1 Month

Secondary Outcomes (3)

• Tumor Response

  1 Month

• Pharmacokinetics

  1 Month

• Pharmacodynamics

  1 Month

Study Arms (1)

1

EXPERIMENTAL

Biological: Gene Modified T Cells

Interventions

Gene Modified T Cells BIOLOGICAL

One time infusion Modified T-Cells given through a vein in the arm or a catheter over a 30-60 minute period.

Also known as: Designer T-Cells, PSMA, Hormone Refractory

1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Roger Williams Medical Center: lead

Study Sites (1)

Roger Williams Medical Center

Providence, Rhode Island, 02908, United States

Location

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

Study Officials

• Richard P Junghans, PhD, MD

  Roger Williams Hospital

  PRINCIPAL INVESTIGATOR

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: April 17, 2008
• First Posted: April 22, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

US (1)