| April 17, 2008 |
| May 1, 2008 |
| April 2008 |
| April 2010 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00664196 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning |
| Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning |
This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells (designer T cells) in hormone refractory prostate cancer. |
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. |
| Phase I |
| Interventional |
| Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Prostate Cancer |
| Biological: Gene Modified T Cells |
| |
| |
| |
| Recruiting |
| 18 |
| April 2010 |
| April 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Histologically confirmed diagnosis of prostate cancer
- Tumor is hormone refractory
- Elevated PSA
- Bone Scan positive for metastatic prostate cancer
- Life expectancy > 4 months
- Performance status 0-1
- WBC > 4.0
- 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
|
| Male |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00664196 |
| Richard P. Junghans, PhD, MD; Principal Investigator, Roger Williams Medical Center |
| 595-04, W81XWH-05-1-0408 |
| Roger Williams Medical Center |
| Department of Defense |
| Principal Investigator: |
Richard P Junghans, PhD, MD |
Roger Williams Hospital |
|
|
| Roger Williams Medical Center |
| May 2008 |