Prostate Cancer Clinical Trial
Official title:
Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning
Verified date | June 2016 |
Source | Roger Williams Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells (designer T cells) in hormone refractory prostate cancer.
Status | Suspended |
Enrollment | 18 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Histologically confirmed diagnosis of prostate cancer 2. Elevated PSA 3. Life expectancy > 4 months 4. Performance status 0-1 5. ANC 1.0 6. Platelets > 100,000 7. Hemoglobin > 8.0 8. Creatinine < 1.5mg/dl 9. Direct Bilirubin < 1.5 mg/dl 10. No evidence of CHF, CAD, cardiac arrhythmias, A-fib, A flutter, myocardial infarction. 11. No serious, symptomatic obstructive or emphysematous lung disease 12. 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 13. Patients must have a biopsy able tumor, and be willing to undergo biopsy (Group 3 only) 14. Patient is at least 18 years of age. Exclusion Criteria: 1. Serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic or allergic disease based on history, labs or physical exam 2. Active clinical disease caused by CMV, Hepatitis B, or C, HIV, TB 3. Cytotoxic and/or radiation therapy during last 4 weeks prior to entry 4. Any concurrent malignancies 5. Patient requires systemic steroids 6. Patient has participated in prior investigational therapy 7. Patient has prior exposure to mouse antibody 8. Patient has had irradiation to whole pelvis or >25% marrow |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roger Williams Medical Center | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Roger Williams Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Tumor Response | 1 Month | No | |
Secondary | Pharmacokinetics | 1 Month | No | |
Secondary | Pharmacodynamics | 1 Month | No |
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