This study is NOT currently recruiting participants.
Number
18-C-0038
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: No longer recruiting/follow-up only Gender: Male & Female Min Age: 4 Years Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
None
Keywords
Synovial Sarcoma; 15 Year Follow-up; Delayed Adverse Events; Natural History
Recruitment Keyword(s)
Condition(s)
Synovial Sarcoma; Sarcoma, Synovial
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
NY-ESO-1c259T is a drug. It is made by permanently transferring genetic material into the body s own T cells. This is done using a process taken from viruses. The process is called a lentivirus vector. This process might cause damage to the body s healthy cells, such as an infection. Researchers want to monitor for this possibility.
Objective:
To find out if the study drug NY-ESO-1c259T has any long-term side effects.
Eligibility:
People who took part in the study 11-C-0113
Design:
Participants will have their health checked for 15 years after they get the study drug.
Participants will have 3 visits in year 1. They will have 2 visits per year in years 2-5. They will have 1 visit per year in years 5-15.
At the visits, participants will have:
Medical history
Physical exam
Blood tests
Medical photos taken to identify side effects
Participants will give the names of any new cancer drugs or therapies they are taking.
Participants will tell the study doctor about any health changes.
Women participants cannot become pregnant or nurse at least 12 months after getting the study drug or 4 months after there is no drug left in their blood. Male participants cannot father a child until 4 months after they last got the study drug. Participants must use acceptable birth control methods if they are sexually active during this time.
If participants die during they study, their family may be asked if an autopsy can be done on their body.
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ELIGIBILITY CRITERIA: Subjects must have received NY-ESO-1c259 T in an GSK clinical study. For NCI patients, 11-C-0113 is the GSK clinical study in which the patients received NYESO-1c259.
Subjects must have received NY-ESO-1c259 T in an GSK clinical study. For NCI patients, 11-C-0113 is the GSK clinical study in which the patients received NYESO-1c259.
Principal Investigator
Referral Contact
For more information: