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

Paused · Phase 1

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT00664196

Run by

Roger Williams Medical Center

People needed

18

Starts

2008-04-01

Expected to finish

2018-12-01

Last updated by the study team

2016-06-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• Roger Williams Medical Center — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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