Status:
SUSPENDED
Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning
Lead Sponsor:
Roger Williams Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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.
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 collec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00664196
Start Date
April 1 2008
End Date
December 1 2018
Last Update
June 17 2016
Active Locations (1)
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1
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908