A Phase 1 interventional study of rsPSMA protein plus Alhydrogel® vaccine in Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-09.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment
The purpose of this research is to help us study a vaccine treatment for patients with prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections and other diseases, such as cancer. Your immune system is made up of many different types of cells which fight infection and disease in your body. A vaccine may stimulate the immune system to destroy the cancer cells. It may also help to slow the growth of the cancer. The vaccine is a solution given as an injection into or under the skin. It is made up of several parts. The first part is PSMA, a protein present in many cancers, especially prostate cancer. It is referred to as rsPSMA when made in a laboratory for this study and is mixed with a material called Alhydrogel® (aluminum hydroxide suspension) which helps the immune system to make more cancer-fighting cells.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 14 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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This is an ascending, multiple dose study in up to 18 patients. As many as eight patients are planned at each of two dose levels, intrapatient dose escalation is not allowed. Six patients will start on 50μg rsPSMA +0.5 mg Alhydrogel® Weeks 1,2,3 and 7.
Biological: rsPSMA protein plus Alhydrogel® vaccine
This is an ascending, multiple dose study in up to 18 patients. As many as eight patients are planned at each of two dose levels, intrapatient dose escalation is not allowed. Eight patients will start on 250μg rsPSMA + 1.0 mg Alhydrogel Weeks 1,2,3 and 7
Biological: rsPSMA protein plus Alhydrogel® vaccine
The assigned dose of rsPSMA protein plus Alhydrogel® vaccine will be administered subcutaneously to random sites on the upper arm and upper leg at weekly intervals for 3 weeks. This will be followed by a 4-week break and then a fourth vaccination during week 7. The vaccination site will rotate to a different quadrant with each administration.
Is to investigate the safety and tolerability of treatment with increasing dose levels of rsPSMA protein when administered with the adjuvant Alhydrogel®.
Time frame: conclusion of study
To evaluate the immune response to increasing dose levels of rsPSMA protein.
Time frame: conclusion of study
To study the pattern of change in PSA after vaccination.
Time frame: conclusion of study
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center