Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies
Follow-Up Study of Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents
About This Trial
- This long-term follow-up study is for adults who previously received a specific gene-based cancer vaccine in an earlier clinical trial.
- It does not test any new medications, but instead checks on your long-term health and safety over time.
- If you participate, you will have a yearly medical checkup and routine blood tests for the first five years, followed by annual phone check-ins for the next ten years.
- You should know that taking part will not interfere with your regular care, and you can still receive other cancer treatments while in this study.
More Information
- This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors.
- Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.
- The study does not involve the use of any drug or biologic agent.
- Participants will undergo an annual health history.
- Because certain viruses enter into cells and create proteins from the viral genes, the type of vaccine treatment used is referred to gene therapy.
- The genes expressed by poxviral vectors do not become part of the genetic material left behind.
- Because gene therapy is a somewhat new technology, a prolonged monitoring of patients' health status is necessary, according to new specific reporting requirements for harmful events in patients who undergo such gene therapy studies.
- The risk of any long-term negative effects from the gene therapy that patients had received is quite small.
- Still, it is important that there be updates at least annually.
- This annual monitoring of health status will extend for 15 years, according to guidelines from the Food and Drug Administration, or for as long as patients are willing to participate.
- Patients who received poxviral vectors (vaccinia or fowlpox, or both) at the National Cancer Institute, through a trial affiliated with the Laboratory of Tumor Immunology and Biology, may be eligible for this study.
- Participants will be involved in the following forms of data collection: - Annual medical history and physical examinations for the first 5 years following the last vaccine. - Annual telephone contact during the last 10 years. - Health status check, including primary cancer status, secondary malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders. - Blood tests for the presence of HIV antibodies. - Reporting of medical problems, including information on unexpected hospitalizations and medications.
- If a participant has died, the study will document the cause of death and autopsy information if available.
Who Can Enroll
- Age Range: 18 years and older
- Gender: All
- Who This Trial is For: This long-term follow-up study is for adults who previously received a specific gene-based cancer vaccine in an earlier clinical trial.
Study Details
- Start Date: September 13, 2004
- Lead Sponsor: National Cancer Institute (NCI)
Full Eligibility Criteria
Inclusion Criteria
- Subjects who received poxviral vectors (vaccinia and/or fowlpox) or other vaccines utilizing gene transfer or any other immunotherapeutic agent through GMB, UOB and LTIB affiliated trials at the National Cancer Institute, as well as subjects at extramural sites receiving these agents as part of a multi-site trial. Available stored specimens obtained from NCI participants in GMB, UOB, and LTIB affiliated protocols may be transferred to this protocol for storage and eventual future research use.
- Subjects must be >= 18 years of age.
Exclusion Criteria
Participants unwilling to participate.
(Please note, participants may participate in this protocol and, at the same time,
participate in an active treatment or continuing care study.)