Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells (designer T cells) in hormone refractory prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: Gene Modified T Cells |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning |
- 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 ]
- 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 ]
| Estimated Enrollment: | 18 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Gene Modified T Cells
One time infusion Modified T-Cells given through a vein in the arm or a catheter over a 30-60 minute period.
Other Names:
|
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 collected by leukopheresis, transported to the RWMC cGMP Cell Manipulation Core and transduced with retrovirus containing a chimeric antigen receptor (CAR) that is expressed on the modified cells. This CAR 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 at a dose of 10^10 with randomization to either low or moderate Interleukin 2 given by CI (continuous infusion) for one month following the T cell infusion. Subsequent subjects will receive 10^11 cells with Interleukin 2 at either low or moderate dose, in a non randomized manner, depending upon the outcome of the prior cohort. Prior to T cell infusion, all subjects will receive 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 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
Contacts and Locations| Contact: Robin A Davies, BA, BSN, RN | 401-456-2419 | rdavies@chartercare.org |
| United States, Rhode Island | |
| Roger Williams Medical Center | Recruiting |
| Providence, Rhode Island, United States, 02908 | |
| Contact: Robin A Davies, BA, BSN, RN 401-456-2419 rdavies@chartercare.org | |
| Principal Investigator: Richard P Junghans, PhD, MD | |
| Principal Investigator: | Richard P Junghans, PhD, MD | Roger Williams Hospital |
More Information
No publications provided
| Responsible Party: | Roger Williams Medical Center |
| ClinicalTrials.gov Identifier: | NCT00664196 History of Changes |
| Other Study ID Numbers: | 595-04, W81XWH-05-1-0408 |
| Study First Received: | April 17, 2008 |
| Last Updated: | May 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Roger Williams Medical Center:
|
Prostate Cancer T cells Gene Transfer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013