This study is NOT currently recruiting participants.
Number
001805-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
Yes
Population Exclusion(s)
Children
Keywords
Gene Transfer; Recombinant DNA Product; Gamma-Retroviral Vectors; Laboratory Evaluation; Natural History
Recruitment Keyword(s)
None
Condition(s)
Cervical Intraepithelial Neoplasia; Cervical Neoplasms; Oropharyngeal Neoplasms; Squamous Intraepithelial Lesions of the Cervix; Hematologic Malignacies
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Other: long-term follow-up
Supporting Site
National Cancer Institute
Gene-modified T cell therapy is an approach to treating cancer. For this treatment, researchers take a type of immune cell called T cells from a person s body; modify the T cell genes to help them target and kill only cancer cells; and put the modified T cells back into the person s body. The treatment is still new, and FDA guidelines require that people who have received this therapy be monitored for up to 15 years.
Objective:
To monitor the long-term health of people have received gene-modified T cell therapy.
Eligibility:
People aged 18 years and older. They must have been treated with gene-modified T cell therapy in a trial supported by Rutgers Cancer Institute or the NIH Clinical Center.
Design:
Participants will have follow-up visits for up to 15 years after receiving gene-modified T cell therapy. They will have 4 visits in the first year. Then they will have visits once a year for the next 4 years.
These visits will include a physical exam with blood tests. Participants will also complete a questionnaire about their health. They will be asked about other cancer treatments they may receive. It may be possible for some of the evaluations/procedures to be done by the participant s treating physician (such as primary care physician, primary oncologist, etc.), instead of the study doctor and staff at the study site.
Participants may stop onsite visits after 5 years. But they will still have annual follow-up visits by email or telephone for 10 more years. A primary care doctor may also share the participant s health information with researchers. Participants may be asked to come back for more in-person testing if adverse events occur.
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INCLUSION CRITERIA: Subjects who are co-enrolled on a T cell gene therapy clinical trial at Rutgers Cancer Institute that requires co-enrollment in this protocol are eligible.
Subjects who are co-enrolled on a T cell gene therapy clinical trial at Rutgers Cancer Institute that requires co-enrollment in this protocol are eligible.
Principal Investigator
Referral Contact
For more information: